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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01401413
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : July 25, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
REM Sleep Behavior Disorder Drug: ramelteon Drug: placebo Phase 4

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder
Study Start Date : January 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon

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 Name: rozerem

Primary Outcome Measures :
  1. Change in polysomnographic scores [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. change in RBD symptom questionnaire and sleep diary [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01401413

United States, New York
Sleep Medicine Centers of WNY
West Seneca, New York, United States, 14224
Sponsors and Collaborators
Sleep Medicine Centers of WNY
Principal Investigator: Daniel I Rifkin, MD Sleep medicine Centers of Western New York

Responsible Party: Daniel I Rifkin, MD, President Identifier: NCT01401413     History of Changes
Other Study ID Numbers: NEU1640207B
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Mental Disorders
REM Sleep Behavior Disorder
Pathologic Processes
REM Sleep Parasomnias
Sleep Wake Disorders
Nervous System Diseases