NCT01401413
Completed
Phase 4
A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder
Sleep Medicine Centers of WNY1 site in 1 country20 target enrollmentJanuary 2008
Overview
- Phase
- Phase 4
- Intervention
- placebo
- Conditions
- REM Sleep Behavior Disorder
- Sponsor
- Sleep Medicine Centers of WNY
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in polysomnographic scores
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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 and assessment scores on the RBD symptom questionnaire and sleep diary.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Meets criteria for RBD as determined by screening PSG's
- •steady bed partner for completion of RBD questionnaire
Exclusion Criteria
- •Hepatic impairment
- •RBD associated with narcolepsy
- •use of fluvoxamine, rifampin, fluconazole or ketoconazole
- •current alcohol or drug abuse
Arms & Interventions
1
placebo control nightly
Intervention: placebo
2
8 mg ramelteon nightly
Intervention: ramelteon
Outcomes
Primary Outcomes
Change in polysomnographic scores
Time Frame: 30 days
Secondary Outcomes
- change in RBD symptom questionnaire and sleep diary(30 days)
Study Sites (1)
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