NCT01401413

Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder

A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sleep Medicine Centers of WNY · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• REM Sleep Behavior Disorder

Interventions

Type	Name	Description
DRUG	ramelteon	8 mg nightly for 30 nights
DRUG	placebo	placebo control i pill nightly for 30 nights

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2011-07-25
• Last updated: 2011-07-25

Locations

1 site across 1 country: United States