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Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02789592
Recruitment Status : Unknown
Verified June 2016 by BS Jeon, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 3, 2016
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
Kuhnil Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE May 31, 2016
First Posted Date  ICMJE June 3, 2016
Last Update Posted Date June 3, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
Clinical Global Impression-Improvement scale (CGI-I) [ Time Frame: Four weeks (plus or minus 3 days) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
  • Mean change of the Clinical Global Impression-Severity scale (CGI-S) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Patient Global Impression-Improvement scale (PGI-I) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Patient Global Impression-Severity scale (PGI-S) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • modified RBD Questionnaire-HongKong (mRBDQ-HK) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Epworth Sleepiness Scale (ESS) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Parkinson Disease Sleep Scale (PDSS) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Montreal Cognitive Assessment (MoCA) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Sleep diary [ Time Frame: Four weeks (plus or minus 3 days) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description

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.

Clonazepam 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • REM Sleep Behavior Disorder
  • Parkinson Disease
Intervention  ICMJE
  • Drug: Melatonin PR
    For experimental treatment of RBD
    Other Name: Circadin
  • Drug: Clonazepam
    For experimental treatment of RBD
    Other Name: Rivotril
  • Drug: Melatonin PR placebo
    Placebo pill manufactured to mask melatonin PR 2mg tablet
    Other Name: Placebo tablet of Melatonin PR
  • Drug: Clonazepam placebo
    Placebo pill manufactured to mask clonazepam 0.5mg tablet
    Other Name: Placebo tablet of clonazepam
Study Arms  ICMJE
  • Experimental: Group 1
    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
    Interventions:
    • Drug: Melatonin PR
    • Drug: Clonazepam
    • Drug: Melatonin PR placebo
    • Drug: Clonazepam placebo
  • Experimental: Group 2
    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
    Interventions:
    • Drug: Melatonin PR
    • Drug: Clonazepam
    • Drug: Melatonin PR placebo
    • Drug: Clonazepam placebo
  • Experimental: Group 3
    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
    Interventions:
    • Drug: Melatonin PR
    • Drug: Clonazepam
    • Drug: Melatonin PR placebo
    • Drug: Clonazepam placebo
  • Experimental: Group 4
    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
    Interventions:
    • Drug: Melatonin PR
    • Drug: Clonazepam
    • Drug: Melatonin PR placebo
    • Drug: Clonazepam placebo
  • Experimental: Group 5
    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
    Interventions:
    • Drug: Melatonin PR
    • Drug: Clonazepam
    • Drug: Melatonin PR placebo
    • Drug: Clonazepam placebo
  • Experimental: Group 6
    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
    Interventions:
    • Drug: Melatonin PR
    • Drug: Clonazepam
    • Drug: Melatonin PR placebo
    • Drug: Clonazepam placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 2, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject was enrolled voluntarily and understood the contents of this clinical trial
  • Subject was diagnosed as Parkinson disease (PD)
  • Hoehn and Yahr (H&Y) stage 1, 2, or 3
  • Existence of caregivers who can provide a information about symptoms of rapid eye movement sleep disorder (RBD) of the participant
  • RBD frequency is one or more per week
  • 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.)?"
  • Good compliance for reporting PGI scores and sleep diary

Exclusion Criteria:

  • Existence of cognitive decline hard to participate in the clinical trial
  • Hypersensitivity to melatonin or clonazepam
  • Previous melatonin or clonazepam treatment within 1 month
  • Changing anti-parkinsonian medications within 1 month
  • Current treatment with sedatives or hypnotics at bedtime
  • Diagnosed as epilepsy or current treatment with anti-epileptic drugs
  • Severe trauma history due to RBD
  • Lactating, pregnant, or possible pregnant
  • Subject has confusion or visual hallucination in daytime
  • Diagnosed as obstructive sleep apnea or severe snoring
  • Diagnosed as other parasomnia
  • Presence of severe psychiatric illness
  • Alcoholics or drug abuser
  • Myasthenia gravis
  • Acute narrow-angle glaucoma
  • Prior participation to other clinical trials within 3 months
  • Presence of severe comorbidities or a cancer
  • Existence of illness or problems which makes difficult to be enrolled to this trial judged by clinicians
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02789592
Other Study ID Numbers  ICMJE H-1604-134-757
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party BS Jeon, Seoul National University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Seoul National University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Kuhnil Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Beomseok Jeon, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP