Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
Study NCT ID:
NCT05529095
Status:
UNKNOWN
Last Update Posted:
2022-09-06
First Post:
2022-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sublingual Apomorphine in Refractory Restless Legs Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale of Improvement', 'timeFrame': 'Weeks 4 - 8', 'description': 'Subjects will assess how they feel 30 minutes after taking four doses of drug or placebo.'}], 'secondaryOutcomes': [{'measure': 'International RLS Rating Scale (IRLS)', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 16 weeks', 'description': 'This is a subjective scale to measure the severity of RLS within the past week.'}, {'measure': 'The Restless Legs Syndrome - 6 Scale (RLS-6)', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 16 weeks', 'description': 'This scale measures the severity of daytime versus nighttime RLS symptoms.'}, {'measure': 'Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL)', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 16 weeks', 'description': 'This scale assess the quality of life in RLS patients.'}, {'measure': 'Hamilton Depression Scale (HDS)', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 16 weeks', 'description': 'This scale assess symptoms of depression.'}, {'measure': 'Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Baseline, 4 weeks, 8 weeks, and 16 weeks', 'description': "This is a subjective scale that measures a patient's sleepiness."}, {'measure': 'Clinical Global Impressions - Change', 'timeFrame': '1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, and 18-20 weeks', 'description': 'This scale assess how much a patients illness has improved or worsened when compared to a baseline state from the beginning of the intervention.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Refractory'], 'conditions': ['Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': 'This is an open label, short placebo-controlled trial in Restless Legs Syndrome (RLS) patients inadequately treated with standard therapy. Investigators hypothesize that the study drug, sublingual apomorphine (Kynmobi), may improve RLS breakthrough symptoms. This study is designed to determine if sublingual apomorphine improves breakthrough symptoms in RLS patients, in addition to subjective responses.', 'detailedDescription': 'This is an open label, with a short placebo-controlled portion trial using sublingual apomorphine (Kynmobi) in RLS patients inadequately treated with standard therapy, defined by an IRLS \\> 15 and report of breakthrough symptoms.\n\nAt the initial visit, subjects will undergo all baseline and exploratory assessments and be given their first drug dose of 10 mg. They will be monitored for 60 minutes after dose. Subjects orthostatic blood pressure will be taken before ingestion, then 10, 20, 30, and 45 minutes after ingestion. Over the next 4 weeks, subjects will titrate Kynmobi to find optimal dose. Subjects will be instructed to take at least 2 doses before determining if further titration is needed.\n\nAt week 4, subjects will return for exploratory assessments. Subjects will be given a randomized study drug packet containing 2 placebos and 2 drug doses. Subjects will be told that 0-4 doses may be placebo or drug. Subjects will have 4 weeks to complete randomization doses. It is anticipated subjects will complete randomization sooner, so they will be given 23 doses of study drug (1 dose per 24 hours for 23 extra days until next visit).\n\nAt week 8, subjects will return for exploratory assessments and be given an additional 74 dosed strips. They will return at week 16 for a final visit and undergo exploratory assessments, followed by a safety call two weeks later.\n\nFrom weeks 0-8, subjects are able to continue their scheduled RLS medications. From weeks 8-16, subjects may make changes to their RLS medications as mutually agreed upon with investigator.\n\nSeveral questionnaire assessments will be conducted throughout the study to monitor subjects. Subjects will complete the International RLS Rating Scale (IRLS), Restless Legs Syndrome - 6 Scale (RLS - 6), RLS Quality of Life Questionnaire (RLSQoL), RLS Augmentation Scale, Fatigue Severity Scale (FSS), Hamilton Depression Scale (HDS), Clinical Global Impressions (CGI), and Clinical Global Impressions-Change (CGI-C).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic RLS diagnosed by standard criteria, with an IRLS \\> 15 while taking at least 1 RLS medication\n* Stable RLS medications for at least 2 weeks prior to study entry\n\nExclusion Criteria:\n\n* Concurrent untreated sleep disorders, not felt to be able stable\n* Subjects with any significant, unstable cardiovascular, liver, lung, renal. psychiatric, or neurological diseases (not including RLS)\n* Any medical or psychiatric comorbidity that, in the opinion of the investigator, would make study compliance difficult to achieve\n* Intravenous iron within 4 weeks of study entry\n* Breast feeding or pregnancy determined by urine pregnancy test in subjects where pregnancy is a possibility (pre-menopausal, sexually active women)\n* Subjects with previous allergic reaction to apomorphine or sulfate sensitivity\n* Subjects currently taking 5HT3 antagonists'}, 'identificationModule': {'nctId': 'NCT05529095', 'briefTitle': 'Sublingual Apomorphine in Refractory Restless Legs Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Open Label and Placebo-Controlled Assessment of Sublingual Apomorphine (Kynmobi) as Adjunct Therapy for Patients With Refractory Restless Legs Syndrome', 'orgStudyIdInfo': {'id': 'PRO00033518'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sublingual Apomorphine (Kynmobi)', 'description': 'Sublingual apomorphine to be titrated after initial dose of 10 mg. Titration is dependent on subjects response.', 'interventionNames': ['Drug: Apomorphine Sublingual Film']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'At week 4, subjects will be given randomization packet including 2 drug doses and 2 placebos.', 'interventionNames': ['Drug: Apomorphine Sublingual Film', 'Drug: Placebo']}], 'interventions': [{'name': 'Apomorphine Sublingual Film', 'type': 'DRUG', 'otherNames': ['Kynmobi'], 'description': 'Sublingual Apomorphine initial dose 10 mg, titrated depending on symptomatic response.', 'armGroupLabels': ['Placebo', 'Sublingual Apomorphine (Kynmobi)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'Placebo (sugar pill)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Shivani Desai, BS', 'role': 'CONTACT', 'email': 'sdesai5@houstonmethodist.org', 'phone': '713-363-8390'}], 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'William Ondo, MD', 'role': 'CONTACT', 'email': 'wondo@houstonmethodist.org', 'phone': '713-363-8184'}, {'name': 'Shivani Desai, BS', 'role': 'CONTACT', 'email': 'sdesai5@houstonmethodist.org', 'phone': '7133638390'}], 'overallOfficials': [{'name': 'William Ondo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William Ondo, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'William Ondo, MD', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}}