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

This study has been completed.

Sponsor:

Information provided by:

Sleep Medicine Centers of WNY

ClinicalTrials.gov Identifier:

NCT01401413

First received: July 22, 2011

Last updated: NA

Last verified: July 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

July 22, 2011

Last Updated Date

July 22, 2011

Start Date ^ICMJE

January 2008

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in polysomnographic scores [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

change in RBD symptom questionnaire and sleep diary [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

REM Sleep Behavior Disorder

Intervention ^ICMJE

Drug: ramelteon
8 mg nightly for 30 nights

Other Name: rozerem
Drug: placebo
placebo control i pill nightly for 30 nights

Study Arm (s)

Placebo Comparator: 1
placebo control nightly

Intervention: Drug: placebo
Active Comparator: 2
8 mg ramelteon nightly

Intervention: Drug: ramelteon

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

September 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01401413

Other Study ID Numbers ^ICMJE

NEU1640207B

Has Data Monitoring Committee

Responsible Party

Daniel I Rifkin, MD, President

Study Sponsor ^ICMJE

Sleep Medicine Centers of WNY

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Daniel I Rifkin, MD

Sleep medicine Centers of Western New York

Information Provided By

Sleep Medicine Centers of WNY

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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