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

REM Sleep Behavior Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401413
• Other study ID #: NEU1640207B
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2011
• Last updated: July 22, 2011
• Start date: January 2008
• Est. completion date: September 2010

Study information

• Verified date: July 2011
• Source: Sleep Medicine Centers of WNY
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• REM Sleep Behavior Disorder

Intervention

Drug:
• ramelteon
8 mg nightly for 30 nights
• placebo
placebo control i pill nightly for 30 nights

Locations

Country	Name	City	State
United States	Sleep Medicine Centers of WNY	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sleep Medicine Centers of WNY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in polysomnographic scores		30 days	No
Secondary	change in RBD symptom questionnaire and sleep diary		30 days	No