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

July 22, 2011 updated by: Sleep Medicine Centers of WNY

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • West Seneca, New York, United States, 14224
        • Sleep Medicine Centers of WNY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
placebo control nightly
Drug: placebo
placebo control i pill nightly for 30 nights
Active Comparator: 2
8 mg ramelteon nightly
Drug: ramelteon
8 mg nightly for 30 nights
Other Names:
  • rozerem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in polysomnographic scores
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
change in RBD symptom questionnaire and sleep diary
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sleep Medicine Centers of WNY

Investigators

  • Principal Investigator: Daniel I Rifkin, MD, Sleep Medicine Centers of Western New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU1640207B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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