We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401413
First Posted: July 25, 2011
Last Update Posted: July 25, 2011
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.
Information provided by:
Sleep Medicine Centers of WNY
July 22, 2011
July 25, 2011
July 25, 2011
January 2008
September 2010   (Final data collection date for primary outcome measure)
Change in polysomnographic scores [ Time Frame: 30 days ]
Same as current
No Changes Posted
change in RBD symptom questionnaire and sleep diary [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
 
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
REM Sleep Behavior Disorder
  • Drug: ramelteon
    8 mg nightly for 30 nights
    Other Name: rozerem
  • Drug: placebo
    placebo control i pill nightly for 30 nights
  • Placebo Comparator: 1
    placebo control nightly
    Intervention: Drug: placebo
  • Active Comparator: 2
    8 mg ramelteon nightly
    Intervention: Drug: ramelteon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01401413
NEU1640207B
No
Not Provided
Not Provided
Daniel I Rifkin, MD, President
Sleep Medicine Centers of WNY
Not Provided
Principal Investigator: Daniel I Rifkin, MD Sleep medicine Centers of Western New York
Sleep Medicine Centers of WNY
July 2011

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