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

Phase 4

Completed

• Conditions: REM Sleep Behavior Disorder
• Interventions: Drug: ramelteon; Drug: placebo

• Registration Number: NCT01401413
• Lead Sponsor: Sleep Medicine Centers of WNY

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-07
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-07-22
• Last Update Submitted: 2011-07-22
• Study First Posted: 2011-07-25
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ramelteon	8 mg ramelteon nightly
1	placebo	placebo control nightly

Primary Outcome Measures

Name	Time	Method
Change in polysomnographic scores	30 days

Secondary Outcome Measures

Name	Time	Method
change in RBD symptom questionnaire and sleep diary	30 days

Trial Locations

Locations (1)

Sleep Medicine Centers of WNY; 🇺🇸 West Seneca, New York, United States