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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

July 22, 2011
July 22, 2011
January 2008
September 2010   (final data collection date for primary outcome measure)
Change in polysomnographic scores [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
change in RBD symptom questionnaire and sleep diary [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01401413
NEU1640207B
No
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