Status:
COMPLETED
Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ministry of Food and Drug Safety, Korea
Conditions:
REM Sleep Behavior Disorder
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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).
Detailed Description
RBD is one of the representative non-motor symptoms of PD and other synucleinopathies. Patients with RBD show dream-enacting behaviors such as punching, kicking, singing, screaming, or somnambulism. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02312908
Start Date
March 1 2015
End Date
March 1 2016
Last Update
April 25 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744