Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-29 @ 6:52 PM
Study NCT ID:
NCT01906866
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2013-07-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D058496', 'term': 'Smith-Magenis Syndrome'}, {'id': 'D017204', 'term': 'Angelman Syndrome'}, {'id': 'D014402', 'term': 'Tuberous Sclerosis'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D006222', 'term': 'Hamartoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D065703', 'term': 'Malformations of Cortical Development, Group I'}, {'id': 'D054220', 'term': 'Malformations of Cortical Development'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'talin@neurim.com', 'phone': '972-7684902', 'title': 'Dr. Tali Nir', 'organization': 'Neurim Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '104 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Circadin 2/5/10 mg Double Blind', 'description': 'Circadin 2/5/10 mg. Double blind period, active arm', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 51, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo arm', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 50, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Circadin 2/5/10 mg Open Label', 'description': 'Circadin 2/5/10 mg. Open-label period, active arm', 'otherNumAtRisk': 95, 'deathsNumAtRisk': 95, 'otherNumAffected': 80, 'seriousNumAtRisk': 95, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Non-serious adverse events', 'notes': 'COUGH DYSPNOEA ASTHMA RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 50, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-serious adverse events', 'notes': 'SOMNOLENCE HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 51, 'numAffected': 42}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-serious adverse events', 'notes': 'FATIGUE PYREXIA HANGOVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 28, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 49, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-serious adverse events', 'notes': 'VOMITING DIARRHOEA NAUSEA CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 58, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-serious adverse events', 'notes': 'MOOD SWINGS AGITATION ANXIETY AGGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 47, 'numAffected': 36}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-serious adverse events', 'notes': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-serious adverse events', 'notes': 'UPPER RESPIRATORY TRACT INFECTION INFLUENZA OTITIS MEDIA GASTROENTERITIS NASOPHARYNGITIS SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 61, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'SAE - Serious adverse event', 'notes': 'PNEUMONIA EYE INFECTION OTITIS MEDIA ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'SAE -Serious adverse event', 'notes': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'SAE -Serious adverse event', 'notes': 'AGGRESSION OPPOSITIONAL DEFIANT DISORDER Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Sleep Time (TST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm Units: minutes arithmetic mean (standard error): 51.03 (±10.46)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo arm Units: minutes arithmetic mean (standard error): 18.71 (±10.82)'}], 'classes': [{'categories': [{'measurements': [{'value': '51.03', 'groupId': 'OG000', 'lowerLimit': '30.3', 'upperLimit': '71.76'}, {'value': '18.71', 'groupId': 'OG001', 'lowerLimit': '-2.73', 'upperLimit': '40.15'}]}]}], 'analyses': [{'pValue': '=0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.32', 'ciLowerLimit': '2.38', 'ciUpperLimit': '62.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'The treatment effect of Circadin® 2/5 mg minitabs was compared to that of a placebo on total sleep time, as assessed by the Sleep and Nap Diary questionnaire, following 13 weeks of double-blind treatment', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the Safety Analysis Set who satisfied all major entry criteria (I.Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double-blind phase.\n\nPatients were classified according to randomized treatment. This analysis set was used for all efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Sleep Latency (Mins)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo arm\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '95.16', 'spread': '59.253', 'groupId': 'OG000'}, {'value': '98.76', 'spread': '73.899', 'groupId': 'OG001'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '60.74', 'spread': '42.111', 'groupId': 'OG000'}, {'value': '76.88', 'spread': '82.589', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.2', 'ciLowerLimit': '-44.61', 'ciUpperLimit': '-5.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.787', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Sleep Latency (minutes) derived from Sleep and Nap Diary following 13 weeks of double-blind treatment with Circadin 2/5 mg minitabs versus placebo.\n\nThe lower the value for sleep latency, the better the outcome.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the Safety Analysis Set who satisfied all major entry criteria (I.Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double-blind phase. Patients were classified according to randomized treatment. This analysis set was used for all efficacy analyses'}, {'type': 'SECONDARY', 'title': 'Duration of Wake After Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo arm\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '64.4', 'spread': '24.421', 'groupId': 'OG000'}, {'value': '64.89', 'spread': '32.525', 'groupId': 'OG001'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '68.75', 'spread': '32.199', 'groupId': 'OG000'}, {'value': '70.89', 'spread': '51.590', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Duration of Wake after Sleep onset period derived from Sleep and Nap Diary following 13 weeks of double-blind treatment with Circadin 2/5 mg minitabs versus placebo.\n\nThe shorter the value, the better the outcome.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Awakenings Per Night', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo arm\n\nPlacebo'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.11', 'spread': '1.655', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '1.441', 'groupId': 'OG001'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '2.37', 'spread': '2.095', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '1.895', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Number of awakenings per night will be assessed by a Sleep and Nap Diary and summarized after 13 weeks of double-blind treatment for each treatment group using descriptive statistics.\n\nThe smaller the number, the better the outcome.', 'unitOfMeasure': 'Number of awakenings per night', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Longest Sleep Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '383.79', 'spread': '117.677', 'groupId': 'OG000'}, {'value': '380.58', 'spread': '118.429', 'groupId': 'OG001'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '451.45', 'spread': '124.933', 'groupId': 'OG000'}, {'value': '414.65', 'spread': '124.993', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Mixed Models for Repeated Measures (MMRM) analysis', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MI analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'The longest sleep period following 13 weeks of double-blind treatment with Circadin 2/5 mg and placebo was evaluated by a Sleep and Nap Diary questionnaire.\n\nThe longer the sleep period, the better the outcome.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full analysis set)'}, {'type': 'SECONDARY', 'title': 'Social Functioning - Children Global Assessment Scale (CGAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo arm\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '17.93', 'groupId': 'OG000'}, {'value': '51.5', 'spread': '18.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': "The Children's Global Assessment Scale (CGAS) Questionnaire measures social functioning at home, in school, and in community settings.\n\nThe scores range from 1, which is the very worst, to 100, which is the very best.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS set'}, {'type': 'SECONDARY', 'title': 'Behavior at Home and in School - Strengths and Difficulties Questionnaire (SDQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10', 'description': 'Circadin 2/5/10. Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '19.6', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '6.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'The Strengths and Difficulties Questionnaire (SDQ) is a brief, 25-item, measure of behavioral and emotional difficulties that can be used to assess behavior at home and in school in children.\n\nThe SDQ consists of 25 items which are divided into 5 subscales: 1) emotional symptoms (5 items); 2) conduct problems (5 items); 3) hyperactivity/inattention (5 items); 4) peer relationship problems (5 items); and 5) prosocial behavior (5 items).\n\nSubscales 1 to 4 are summed to generate a Total Difficulties Score (that ranges from 0 to 40). Each item on the SDQ is scored on a 3-point ordinal scale with 0 = not true, 1 = somewhat true, and 2 = certainly true, with higher scores indicating larger problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Dropouts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg. Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo. Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'Number of dropouts during the 13 weeks of double-blind treatment in the Circadin 2/5 mg and placebo arms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'Assessment of Sleep Parameters by Actigraphy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo arm\n\nPlacebo'}], 'classes': [{'title': 'Change in TST (total sleep time)', 'categories': [{'measurements': [{'value': '7.23', 'spread': '96.521', 'groupId': 'OG000'}, {'value': '-23.94', 'spread': '61.860', 'groupId': 'OG001'}]}]}, {'title': 'Change in sleep latency', 'categories': [{'measurements': [{'value': '25.11', 'spread': '38.371', 'groupId': 'OG000'}, {'value': '-12.50', 'spread': '24.744', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity over days to weeks using a noninvasive device.\n\nDespite major efforts to ensure adherence, actigraphy monitoring was challenging in this population, and a majority of patients (75% in the Circadin and 77% in the placebo group) refused to wear the device and/or took it off sometime during the night. Only 12 patients in the Circadin and 13 in the placebo group had data for both baseline and 13 weeks of treatment, and even in those it was not possible to ascertain that they wore the device throughout the night.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Despite major efforts to ensure adherence, actigraphy monitoring was challenging in this population, and a majority of patients (75% in the Circadin and 77% in the placebo group) refused to wear the device during one or both periods and/or took it off some time during the night. Only 12 patients in the Circadin and 13 in the placebo group had data for both baseline and 13 weeks of treatment, and even in those it was not possible to ascertain that they wore the device throughout the night.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Treatment Emergent Signs and Symptoms (TESS) Summary.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg. Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo. Control group'}], 'classes': [{'title': 'Somnolence - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increased Excitability - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Increased Excitability - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Increased Excitability - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Increased Excitability - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hangover Feelings - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hangover Feelings - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hangover Feelings - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hangover Feelings - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mood Swings - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Mood Swings - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Mood Swings - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Mood Swings - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Tremor - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tremor - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tremor - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tremor - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Seizures - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Seizures - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Seizures - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Seizures - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Headache - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea/ Vomiting - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea/ Vomiting - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea/ Vomiting - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nausea/ Vomiting - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Rash - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypothermia - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypothermia - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypothermia - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypothermia - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Coughing/ Breathlessness - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Coughing/ Breathlessness - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Coughing/ Breathlessness - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Coughing/ Breathlessness - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other Adverse Event - Baseline', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other Adverse Event - 13 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other Adverse Event - 26 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other Adverse Event - 52 weeks', 'categories': [{'title': 'No Symptoms', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Treatment Emergent Signs and Symptoms (TESS). Signs and symptoms not seen at baseline (i.e. before starting the treatment) and/or worsened even if present at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group'}], 'classes': [{'title': 'Diastolic - Baseline', 'categories': [{'measurements': [{'value': '64.3', 'spread': '8.31', 'groupId': 'OG000'}, {'value': '63.9', 'spread': '10.11', 'groupId': 'OG001'}]}]}, {'title': 'Systolic - Baseline', 'categories': [{'measurements': [{'value': '104.5', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '104.7', 'spread': '13.94', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic - 13 weeks', 'categories': [{'measurements': [{'value': '65.5', 'spread': '8.74', 'groupId': 'OG000'}, {'value': '65.9', 'spread': '10.73', 'groupId': 'OG001'}]}]}, {'title': 'Systolic - 13 weeks', 'categories': [{'measurements': [{'value': '105.5', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '106.5', 'spread': '12.57', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic - 26 weeks', 'categories': [{'measurements': [{'value': '64.5', 'spread': '9.65', 'groupId': 'OG000'}, {'value': '65.1', 'spread': '10.06', 'groupId': 'OG001'}]}]}, {'title': 'Systolic - 26 weeks', 'categories': [{'measurements': [{'value': '105.3', 'spread': '12.49', 'groupId': 'OG000'}, {'value': '107.3', 'spread': '15.46', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic - 52 weeks', 'categories': [{'measurements': [{'value': '65.8', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '66.2', 'spread': '9.84', 'groupId': 'OG001'}]}]}, {'title': 'Systolic - 52 weeks', 'categories': [{'measurements': [{'value': '106.9', 'spread': '12.81', 'groupId': 'OG000'}, {'value': '108.1', 'spread': '14.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Systolic and Diastolic Blood Pressure (mmHg) A normal blood pressure (BP) level is lower than 140/70 mmHg, meaning systolic BP values lower than 140 mmHg, and diastolic BP values lower than 70 mmHg.\n\nValues within the normal range mean good safety and tolerability outcomes.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Pulse (Beats Per Minute)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '89.2', 'spread': '13.84', 'groupId': 'OG000'}, {'value': '92.3', 'spread': '21.42', 'groupId': 'OG001'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '90.7', 'spread': '15.98', 'groupId': 'OG000'}, {'value': '94.4', 'spread': '17.96', 'groupId': 'OG001'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '86.1', 'spread': '13.01', 'groupId': 'OG000'}, {'value': '97', 'spread': '20.16', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '86.5', 'spread': '14.46', 'groupId': 'OG000'}, {'value': '94.2', 'spread': '19.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Safety and tolerability of Circadin treatment compared to placebo: Pulse rate. The normal pulse for healthy adults ranges from 60 to 100 beats per minute (bpm).\n\nValues within the normal range mean good safety and tolerability outcomes.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Respiratory Rate (Bpm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '19.2', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '4.33', 'groupId': 'OG001'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '19.2', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '4.36', 'groupId': 'OG001'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '18.7', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '20', 'spread': '4.97', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '18.4', 'spread': '3.84', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '4.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Respiratory rate (breaths per minute). The normal respiratory rate for elderly individuals living independently is 12-18 breaths per minute while it is 16-25 breaths per minute for those needing long-term care.\n\nValues within the normal range mean good safety and tolerability outcomes.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability - Body Temperature (°C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Circadin 2/5/10', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Control group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.69', 'spread': '0.479612', 'groupId': 'OG000'}, {'value': '36.54', 'spread': '0.684174', 'groupId': 'OG001'}]}]}, {'title': '13 weeks', 'categories': [{'measurements': [{'value': '36.68', 'spread': '0.464637', 'groupId': 'OG000'}, {'value': '36.63', 'spread': '0.369984', 'groupId': 'OG001'}]}]}, {'title': '26 weeks', 'categories': [{'measurements': [{'value': '36.76', 'spread': '0.459521', 'groupId': 'OG000'}, {'value': '36.57', 'spread': '0.371819', 'groupId': 'OG001'}]}]}, {'title': '52 weeks', 'categories': [{'measurements': [{'value': '36.70', 'spread': '0.457630', 'groupId': 'OG000'}, {'value': '36.65', 'spread': '0.439824', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Body Temperature (°C). Normal body temperature varies by person, age, activity, and time of day. It ranges from 36.1°C to 37.2°C.\n\nValues within the normal range mean good safety and tolerability outcomes.', 'unitOfMeasure': '°C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo arm\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Circadin 2/5/10 mg', 'description': 'Circadin 2/5/10 mg: Active arm'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo arm\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '4.08', 'groupId': 'BG000'}, {'value': '8.4', 'spread': '4.24', 'groupId': 'BG001'}, {'value': '8.7', 'spread': '4.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All patients in the Safety Analysis Set who satisfied all major entry criteria (Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double blind phase. Patients were classified according to randomized treatment. This analysis set was used for all efficacy analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-19', 'size': 1223486, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-07T05:51', 'hasProtocol': True}, {'date': '2016-10-10', 'size': 498865, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-07T05:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-21', 'studyFirstSubmitDate': '2013-07-11', 'resultsFirstSubmitDate': '2018-10-02', 'studyFirstSubmitQcDate': '2013-07-21', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-02', 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Sleep Time (TST)', 'timeFrame': '13 weeks', 'description': 'The treatment effect of Circadin® 2/5 mg minitabs was compared to that of a placebo on total sleep time, as assessed by the Sleep and Nap Diary questionnaire, following 13 weeks of double-blind treatment'}], 'secondaryOutcomes': [{'measure': 'Sleep Latency (Mins)', 'timeFrame': '13 weeks', 'description': 'Sleep Latency (minutes) derived from Sleep and Nap Diary following 13 weeks of double-blind treatment with Circadin 2/5 mg minitabs versus placebo.\n\nThe lower the value for sleep latency, the better the outcome.'}, {'measure': 'Duration of Wake After Sleep', 'timeFrame': '13 weeks', 'description': 'Duration of Wake after Sleep onset period derived from Sleep and Nap Diary following 13 weeks of double-blind treatment with Circadin 2/5 mg minitabs versus placebo.\n\nThe shorter the value, the better the outcome.'}, {'measure': 'Number of Awakenings Per Night', 'timeFrame': '13 weeks', 'description': 'Number of awakenings per night will be assessed by a Sleep and Nap Diary and summarized after 13 weeks of double-blind treatment for each treatment group using descriptive statistics.\n\nThe smaller the number, the better the outcome.'}, {'measure': 'Longest Sleep Period', 'timeFrame': '13 weeks', 'description': 'The longest sleep period following 13 weeks of double-blind treatment with Circadin 2/5 mg and placebo was evaluated by a Sleep and Nap Diary questionnaire.\n\nThe longer the sleep period, the better the outcome.'}, {'measure': 'Social Functioning - Children Global Assessment Scale (CGAS)', 'timeFrame': '13 weeks', 'description': "The Children's Global Assessment Scale (CGAS) Questionnaire measures social functioning at home, in school, and in community settings.\n\nThe scores range from 1, which is the very worst, to 100, which is the very best."}, {'measure': 'Behavior at Home and in School - Strengths and Difficulties Questionnaire (SDQ)', 'timeFrame': '13 weeks', 'description': 'The Strengths and Difficulties Questionnaire (SDQ) is a brief, 25-item, measure of behavioral and emotional difficulties that can be used to assess behavior at home and in school in children.\n\nThe SDQ consists of 25 items which are divided into 5 subscales: 1) emotional symptoms (5 items); 2) conduct problems (5 items); 3) hyperactivity/inattention (5 items); 4) peer relationship problems (5 items); and 5) prosocial behavior (5 items).\n\nSubscales 1 to 4 are summed to generate a Total Difficulties Score (that ranges from 0 to 40). Each item on the SDQ is scored on a 3-point ordinal scale with 0 = not true, 1 = somewhat true, and 2 = certainly true, with higher scores indicating larger problems.'}, {'measure': 'Number of Dropouts', 'timeFrame': '13 weeks', 'description': 'Number of dropouts during the 13 weeks of double-blind treatment in the Circadin 2/5 mg and placebo arms.'}, {'measure': 'Assessment of Sleep Parameters by Actigraphy', 'timeFrame': '13 weeks', 'description': 'Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity over days to weeks using a noninvasive device.\n\nDespite major efforts to ensure adherence, actigraphy monitoring was challenging in this population, and a majority of patients (75% in the Circadin and 77% in the placebo group) refused to wear the device and/or took it off sometime during the night. Only 12 patients in the Circadin and 13 in the placebo group had data for both baseline and 13 weeks of treatment, and even in those it was not possible to ascertain that they wore the device throughout the night.'}, {'measure': 'Safety and Tolerability - Treatment Emergent Signs and Symptoms (TESS) Summary.', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Treatment Emergent Signs and Symptoms (TESS). Signs and symptoms not seen at baseline (i.e. before starting the treatment) and/or worsened even if present at baseline.'}, {'measure': 'Safety and Tolerability - Blood Pressure (mmHg)', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Systolic and Diastolic Blood Pressure (mmHg) A normal blood pressure (BP) level is lower than 140/70 mmHg, meaning systolic BP values lower than 140 mmHg, and diastolic BP values lower than 70 mmHg.\n\nValues within the normal range mean good safety and tolerability outcomes.'}, {'measure': 'Safety and Tolerability - Pulse (Beats Per Minute)', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Safety and tolerability of Circadin treatment compared to placebo: Pulse rate. The normal pulse for healthy adults ranges from 60 to 100 beats per minute (bpm).\n\nValues within the normal range mean good safety and tolerability outcomes.'}, {'measure': 'Safety and Tolerability - Respiratory Rate (Bpm)', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Respiratory rate (breaths per minute). The normal respiratory rate for elderly individuals living independently is 12-18 breaths per minute while it is 16-25 breaths per minute for those needing long-term care.\n\nValues within the normal range mean good safety and tolerability outcomes.'}, {'measure': 'Safety and Tolerability - Body Temperature (°C)', 'timeFrame': '13 weeks, 26 weeks, 52 weeks.', 'description': 'Body Temperature (°C). Normal body temperature varies by person, age, activity, and time of day. It ranges from 36.1°C to 37.2°C.\n\nValues within the normal range mean good safety and tolerability outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleep disturbance', 'Circadian', 'Prolong release melatonin', 'Autism Spectrum Disorder', 'Smith-Magenis Syndrome', 'Angelman Syndrome', 'tuberous sclerosis'], 'conditions': ['Sleep Disorders']}, 'referencesModule': {'references': [{'pmid': '31982581', 'type': 'DERIVED', 'citation': 'Malow BA, Findling RL, Schroder CM, Maras A, Breddy J, Nir T, Zisapel N, Gringras P. Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2021 Feb;60(2):252-261.e3. doi: 10.1016/j.jaac.2019.12.007. Epub 2020 Jan 23.'}, {'pmid': '29096777', 'type': 'DERIVED', 'citation': 'Gringras P, Nir T, Breddy J, Frydman-Marom A, Findling RL. Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):948-957.e4. doi: 10.1016/j.jaac.2017.09.414. Epub 2017 Sep 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks.', 'detailedDescription': 'This is a randomized placebo-controlled study in children diagnosed with autism spectrum disorders (ASDs) and neurodevelopmental disabilities caused by neurogenetic diseases.\n\nChildren who are found to be eligible for the study will follow a 4-week, basic sleep hygiene and behavioral intervention wash-out period, and will continue in a 2-week single-blind (SB) placebo run-in period. Then, they will be randomized in a 1:1 ratio to receive either Circadin® 2 mg or placebo for 3 weeks in a double-blind treatment period.\n\nAfter 3 weeks of treatment, on the last day of Week 5 ±3 days (Visit 3), sleep variables will be assessed to determine if dose modification (an increase to 5 mg) is required. Children will then continue on 2 or 5 mg of Circadin® or placebo for an additional double-blind period of 10 weeks. This double-blind period will be followed by an open-label period of 13 weeks. At the end of the 13-week open-label period on the last day of Week 28 ±3 days (Visit 5), sleep variables will be assessed to determine if a potential additional dose modification (i.e., an increase either to 5 mg for patients who are still on 2 mg or an increase to 10 mg for patients who are on 5 mg) is necessary (If a dose increase is decided upon, the dose increase should be from 2 mg to 5 mg, or 5 mg to 10 mg). Children will continue at 2, 5, or 10 mg Circadin® in an open-label period for another 78 weeks of follow-up, which will include continuous safety monitoring and 2 efficacy assessment time points at Weeks 41 and 54. The study will end with a 2-week SB placebo run-out period.\n\nEach patient will participate in the study until the end of the second open-label safety follow-up period, and 2 week run-out period. The study duration will be 112 weeks, including the 4-week wash-out period with sleep hygiene and behavioral intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nTo be eligible for study entry, all patients must satisfy all of the following criteria at screening:\n\n1. Must be children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug\n2. Must have written informed consent provided by a legal guardian and assent (if needed)\n3. Must have a documented history of ASD according to or consistent with the ICD-10 (International Classification of Diseases) or DSM-5/4 (Diagnostic and Statistical Manual of Mental Disorders) criteria, or neurodevelopmental disabilities caused by neurogenetic diseases (i.e., Smith-Magenis syndrome, Angelman syndrome, Bourneville's disease \\[tuberous sclerosis\\]) as confirmed by case note review showing that diagnosis was reached through assessment by a community pediatrician or pediatric neurologist or other health care professionals experienced in the diagnosis who took into account early developmental history and school records.\n4. Must have current sleep problems including: a minimum of 3 months of impaired sleep defined as ≤6 hours of continuous sleep AND/OR ≥0.5 hour sleep latency from light off in 3 out of 5 nights based on parent reports and patient medical history. (The maintenance and latency problems do not necessarily have to be in the same 3 nights of the week.)\n5. May be on a stable dose of non-excluded medication for 3 months, including anti- epileptics, anti-depressants (selective serotonin reuptake inhibitors \\[SSRIs\\]), stimulants, all mood changing drugs and β-blockers. (Only morning administration of β-blockers is allowed since β-blockers at night have the potential to reduce endogenous melatonin levels and might cause disturbed sleep)\n6. The sleep disturbance is not due to the direct physiological effects of any concomitant medications such as SSRIs, stimulants, etc.\n\nAfter completing 4 weeks of sleep hygiene training (for those who need it) and 2 weeks of placebo run-in, patients will be eligible to continue the study if they comply with the following:\n\n* Continue to fulfill sleep problem criteria (see Inclusion Criterion 4) based on the completed Sleep and Nap Diary entered into the electronic case report form\n* Parents demonstrate compliance in Sleep and Nap Diary completion (5 out of 7 nights). Compliance means that in at least 5 out of 7 nights per week (total of 2 weeks before each scheduled visit) the parents complete the diary pages with all mandatory questions\n* Continue to fulfil all other eligibility criteria\n\nExclusion Criteria:\n\nChildren who meet any of the following criteria will be excluded from participating in the study:\n\n1. Have had treatment with any form of melatonin within 2 weeks prior to Visit 1\n2. Have a known allergy to melatonin or lactose\n3. Have a known moderate to severe sleep apnea\n4. Have an untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances\n5. Did not respond to previous Circadin® therapy based on past medical history records in the last 2 years\n6. Are taking or have been taking prohibited medication within 2 weeks prior to Visit 1 (Section 7.1)\n7. Are females of child-bearing potential that are not using contraceptives and/or breastfeeding and that are sexually active (Abstinence is an acceptable method of contraception.)\n8. Pregnant females\n9. Are currently participating in a clinical trial or have participated in a clinical trial involving medicinal product within the last 3 months prior to the study \\[this does not include patients who participated in the Phase I Pharmacokinetics (PK) study who can be already included in the study\\]\n10. Children with known renal or hepatic insufficiency"}, 'identificationModule': {'nctId': 'NCT01906866', 'briefTitle': 'Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurim Pharmaceuticals Ltd.'}, 'officialTitle': 'A Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Circadin® to Alleviate Sleep Disturbances in Children With Neurodevelopmental Disabilities', 'orgStudyIdInfo': {'id': 'NEU_CH_7911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Circadin 2/5/10 mg', 'description': 'Active arm', 'interventionNames': ['Drug: Circadin 2/5/10 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo arm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Circadin 2/5/10 mg', 'type': 'DRUG', 'otherNames': ['Active arm'], 'description': 'Circadin 2/5/10 mg. Active arm', 'armGroupLabels': ['Circadin 2/5/10 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Control'], 'description': 'Control arm', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Autism Research and Resource Center (SARRC)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Crystal BioMedical Research, LLC', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Lake Mary Pediatrics', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33408', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mate Lazlo', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30080-6315', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', 'facility': 'Attalla Consultants LLC, dba Institue for Behabiovral medicine', 'geoPoint': {'lat': 33.88399, 'lon': -84.51438}}, {'zip': '60563', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'AMR Baber research INC', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kennedy Krieger Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Child Neurology Specialists/ CRCN', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical research center of New Jersey, LLC', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geinsinger Clinic', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '19104-4399', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The children's hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'INSITE Clinical Research', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Red Oak Psychiatry Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy & Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Road Runner Research, Ltd', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '32763', 'city': 'Clinton', 'state': 'Utah', 'country': 'United States', 'facility': 'Ericksen Research & Development', 'geoPoint': {'lat': 41.13967, 'lon': -112.0505}}, {'zip': '98011', 'city': 'Bothell', 'state': 'Washington', 'country': 'United States', 'facility': 'Pacific institute of medical science', 'geoPoint': {'lat': 47.76232, 'lon': -122.2054}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki Sleep Clinic Vitalmed OY', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Garches', 'country': 'France', 'facility': 'Hospital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Strasbourg University Hospital Depatment of Child Psychiatry & Neurology', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Yulius Mental Health Organization', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'city': 'Ede', 'country': 'Netherlands', 'facility': 'Hospital Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham Childrens Hospital NHS FOUNDATION TRUST', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's & St. Thomas's NHS Foundation Trust of St Thomas's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Paul Gringras, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Thoma's Hospital, Westminster Bridge Rd, London"}, {'name': 'Robert Findling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kennedy Krieger Institute, Baltimore, Maryland, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurim Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}