Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether clonazepam is 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: Ministry of Food and Drug Safety, Korea
• Treatments: Clonazepam

Criteria

Inclusion Criteria:

• Subject was enrolled voluntarily and understood the contents of this clinical trial

• Subject was diagnosed as Parkinson disease (PD) or Parkinson's syndrome

• 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

• 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.)?"

Exclusion Criteria:

• Existence of cognitive decline hard to participate in the clinical trial

• Subject has confusion or visual hallucination in daytime

• Diagnosed as obstructive sleep apnea or severe snoring

• Previous clonazepam treatment within 4 weeks

• Current treatment with benzodiazepines at bedtime

• Alcoholics or drug abuser

• Lactating, pregnant, or possible pregnant

• Hypersensitivity to clonazepam or benzodiazepines

• 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