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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 June 2016
• Main ID: NCT02789592
• Date of registration: 31/05/2016
• Prospective Registration: Yes
• Primary sponsor: Seoul National University Hospital
• Public title: Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease
• Scientific title: 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
• Date of first enrolment: July 2016
• Target sample size: 30
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02789592
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Beomseok Jeon, MD, PhD

• Name: Beomseok Jeon, MD, PhD
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

REM Sleep Behavior Disorder

Parkinson Disease

Intervention(s)

Drug: Clonazepam placebo

Drug: Melatonin PR

Drug: Melatonin PR placebo

Drug: Clonazepam

Primary Outcome(s)

Clinical Global Impression-Improvement scale (CGI-I) [Time Frame: Four weeks (plus or minus 3 days)]

Secondary Outcome(s)

Mean change of the Parkinson Disease Sleep Scale (PDSS) [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)]

Mean change of the Montreal Cognitive Assessment (MoCA) [Time Frame: Four weeks (plus or minus 3 days)]

Mean change of the Clinical Global Impression-Severity scale (CGI-S) [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)]

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)]

Patient Global Impression-Improvement scale (PGI-I) [Time Frame: Four weeks (plus or minus 3 days)]

Sleep diary [Time Frame: Four weeks (plus or minus 3 days)]

Secondary ID(s)

H-1604-134-757

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kuhnil Pharmaceutical Co., Ltd.