Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-17 @ 3:06 PM
Study NCT ID:
NCT02789592
Status:
UNKNOWN
Last Update Posted:
2016-06-03
First Post:
2016-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}, {'id': 'D002998', 'term': 'Clonazepam'}], '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'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-02', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-02', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression-Improvement scale (CGI-I)', 'timeFrame': 'Four weeks (plus or minus 3 days)', 'description': 'Clinician assessed rating scale of clinical improvement or worsening relative to a baseline state, scored as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.'}], 'secondaryOutcomes': [{'measure': 'Mean change of the Clinical Global Impression-Severity scale (CGI-S)', 'timeFrame': 'Four weeks (plus or minus 3 days)'}, {'measure': 'Patient Global Impression-Improvement scale (PGI-I)', 'timeFrame': 'Four weeks (plus or minus 3 days)'}, {'measure': 'Mean change of the Patient Global Impression-Severity scale (PGI-S)', 'timeFrame': 'Four weeks (plus or minus 3 days)'}, {'measure': 'modified RBD Questionnaire-HongKong (mRBDQ-HK)', 'timeFrame': 'Four weeks (plus or minus 3 days)'}, {'measure': 'Mean change of the Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Four weeks (plus or minus 3 days)'}, {'measure': 'Mean change of the Parkinson Disease Sleep Scale (PDSS)', 'timeFrame': 'Four weeks (plus or minus 3 days)'}, {'measure': 'Mean change of the Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Four weeks (plus or minus 3 days)'}, {'measure': "Mean change of the Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': 'Four weeks (plus or minus 3 days)'}, {'measure': 'Sleep diary', 'timeFrame': 'Four weeks (plus or minus 3 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['REM Sleep Behavior Disorder', 'Parkinson Disease', 'Randomized Controlled Trial', 'Clinical Trial', 'Melatonin', 'Clonazepam'], 'conditions': ['REM Sleep Behavior Disorder', 'Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '22447623', 'type': 'BACKGROUND', 'citation': 'Arnulf I. REM sleep behavior disorder: motor manifestations and pathophysiology. Mov Disord. 2012 May;27(6):677-89. doi: 10.1002/mds.24957. Epub 2012 Mar 22.'}, {'pmid': '21832215', 'type': 'BACKGROUND', 'citation': 'Sixel-Doring F, Trautmann E, Mollenhauer B, Trenkwalder C. Associated factors for REM sleep behavior disorder in Parkinson disease. Neurology. 2011 Sep 13;77(11):1048-54. doi: 10.1212/WNL.0b013e31822e560e. Epub 2011 Aug 10.'}, {'pmid': '20561180', 'type': 'BACKGROUND', 'citation': 'Kunz D, Mahlberg R. A two-part, double-blind, placebo-controlled trial of exogenous melatonin in REM sleep behaviour disorder. J Sleep Res. 2010 Dec;19(4):591-6. doi: 10.1111/j.1365-2869.2010.00848.x.'}, {'pmid': '23886593', 'type': 'BACKGROUND', 'citation': 'Schenck CH, Montplaisir JY, Frauscher B, Hogl B, Gagnon JF, Postuma R, Sonka K, Jennum P, Partinen M, Arnulf I, Cochen de Cock V, Dauvilliers Y, Luppi PH, Heidbreder A, Mayer G, Sixel-Doring F, Trenkwalder C, Unger M, Young P, Wing YK, Ferini-Strambi L, Ferri R, Plazzi G, Zucconi M, Inoue Y, Iranzo A, Santamaria J, Bassetti C, Moller JC, Boeve BF, Lai YY, Pavlova M, Saper C, Schmidt P, Siegel JM, Singer C, St Louis E, Videnovic A, Oertel W. Rapid eye movement sleep behavior disorder: devising controlled active treatment studies for symptomatic and neuroprotective therapy--a consensus statement from the International Rapid Eye Movement Sleep Behavior Disorder Study Group. Sleep Med. 2013 Aug;14(8):795-806. doi: 10.1016/j.sleep.2013.02.016. Epub 2013 Jul 22.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).", 'detailedDescription': 'RBD is one of the representative non-motor symptoms of PD. Patients with RBD show dream-enacting behaviors such as punching, kicking, singing, screaming, or somnambulism. These can interfere in sleep quality and increase the risk of falling down from the bed and physical injuries of both the patient and sleep partner. Therefore, qualities of life of the patient and sleep partner are negatively influenced by presence of RBD.\n\nClonazepam has been used for treatment of choice of RBD. However, the efficacy of clonazepam is not proven in the clinical trial. Clonazepam has several side effects that could be problematic in PD patients such as increasing fall-down risk, daytime somnolence, and cognitive decline. Melatonin is a second-line treatment option for RBD, but there has been only one randomized crossover trial that evaluated the efficacy of melatonin on RBD. Finally, there has been no study that evaluate and compare the efficacy and safety of melatonin and clonazepam for treatment of RBD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject was enrolled voluntarily and understood the contents of this clinical trial\n* Subject was diagnosed as Parkinson disease (PD)\n* Hoehn and Yahr (H\\&Y) stage 1, 2, or 3\n* Existence of caregivers who can provide a information about symptoms of rapid eye movement sleep disorder (RBD) of the participant\n* RBD frequency is one or more per week\n* Existence of RBD by answering "yes" to the question (RBD-1Q): "Have you ever been told, or suspected yourself, that you seem to \'act out your dreams\' while asleep (for example, punching, flailing your arms in the air, making running movements, etc.)?"\n* Good compliance for reporting PGI scores and sleep diary\n\nExclusion Criteria:\n\n* Existence of cognitive decline hard to participate in the clinical trial\n* Hypersensitivity to melatonin or clonazepam\n* Previous melatonin or clonazepam treatment within 1 month\n* Changing anti-parkinsonian medications within 1 month\n* Current treatment with sedatives or hypnotics at bedtime\n* Diagnosed as epilepsy or current treatment with anti-epileptic drugs\n* Severe trauma history due to RBD\n* Lactating, pregnant, or possible pregnant\n* Subject has confusion or visual hallucination in daytime\n* Diagnosed as obstructive sleep apnea or severe snoring\n* Diagnosed as other parasomnia\n* Presence of severe psychiatric illness\n* Alcoholics or drug abuser\n* Myasthenia gravis\n* Acute narrow-angle glaucoma\n* Prior participation to other clinical trials within 3 months\n* Presence of severe comorbidities or a cancer\n* Existence of illness or problems which makes difficult to be enrolled to this trial judged by clinicians'}, 'identificationModule': {'nctId': 'NCT02789592', 'briefTitle': 'Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson Disease', 'orgStudyIdInfo': {'id': 'H-1604-134-757'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Phase 1: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks', 'interventionNames': ['Drug: Melatonin PR', 'Drug: Clonazepam', 'Drug: Melatonin PR placebo', 'Drug: Clonazepam placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Phase 1: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks', 'interventionNames': ['Drug: Melatonin PR', 'Drug: Clonazepam', 'Drug: Melatonin PR placebo', 'Drug: Clonazepam placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Phase 1: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks', 'interventionNames': ['Drug: Melatonin PR', 'Drug: Clonazepam', 'Drug: Melatonin PR placebo', 'Drug: Clonazepam placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Phase 1: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks', 'interventionNames': ['Drug: Melatonin PR', 'Drug: Clonazepam', 'Drug: Melatonin PR placebo', 'Drug: Clonazepam placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5', 'description': 'Phase 1: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks', 'interventionNames': ['Drug: Melatonin PR', 'Drug: Clonazepam', 'Drug: Melatonin PR placebo', 'Drug: Clonazepam placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6', 'description': 'Phase 1: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks', 'interventionNames': ['Drug: Melatonin PR', 'Drug: Clonazepam', 'Drug: Melatonin PR placebo', 'Drug: Clonazepam placebo']}], 'interventions': [{'name': 'Melatonin PR', 'type': 'DRUG', 'otherNames': ['Circadin'], 'description': 'For experimental treatment of RBD', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'Clonazepam', 'type': 'DRUG', 'otherNames': ['Rivotril'], 'description': 'For experimental treatment of RBD', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'Melatonin PR placebo', 'type': 'DRUG', 'otherNames': ['Placebo tablet of Melatonin PR'], 'description': 'Placebo pill manufactured to mask melatonin PR 2mg tablet', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'Clonazepam placebo', 'type': 'DRUG', 'otherNames': ['Placebo tablet of clonazepam'], 'description': 'Placebo pill manufactured to mask clonazepam 0.5mg tablet', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Beomseok Jeon, MD, PhD', 'role': 'CONTACT', 'email': 'brain@snu.ac.kr'}, {'name': 'Chae Won Shin, MD, MSc', 'role': 'CONTACT', 'email': 'chroma0202@gmail.com'}], 'overallOfficials': [{'name': 'Beomseok Jeon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kuhnil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'BS Jeon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}