Status:
COMPLETED
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
Lead Sponsor:
Sleep Medicine Centers of WNY
Conditions:
REM Sleep Behavior Disorder
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.
Detailed Description
This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score ...
Eligibility Criteria
Inclusion
- Meets criteria for RBD as determined by screening PSG's
- steady bed partner for completion of RBD questionnaire
Exclusion
- Hepatic impairment
- RBD associated with narcolepsy
- use of fluvoxamine, rifampin, fluconazole or ketoconazole
- current alcohol or drug abuse
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01401413
Start Date
January 1 2008
End Date
September 1 2010
Last Update
July 25 2011
Active Locations (1)
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1
Sleep Medicine Centers of WNY
West Seneca, New York, United States, 14224