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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Kuhnil Pharmaceutical Co., Ltd.
• Treatments: Clonazepam; Melatonin

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