Trial | NCT01401413  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ramelteon ...

  • Study Participants

    20
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.
Study Started
Jan 31
2008
Primary Completion
Sep 30
2010
Study Completion
Sep 30
2010
Last Update
Jul 25
2011
Estimate

Drug ramelteon

8 mg nightly for 30 nights

  • Other names: rozerem

Drug placebo

placebo control i pill nightly for 30 nights

1 Placebo Comparator

placebo control nightly

2 Active Comparator

8 mg ramelteon nightly

Criteria 

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
No Results Posted