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

This study has been completed.
Information provided by:
Sleep Medicine Centers of WNY Identifier:
First received: July 22, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.

Condition Intervention Phase
REM Sleep Behavior Disorder
Drug: ramelteon
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Sleep Medicine Centers of WNY:

Primary Outcome Measures:
  • Change in polysomnographic scores [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in RBD symptom questionnaire and sleep diary [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Daniel I Rifkin, MD, President Identifier: NCT01401413     History of Changes
Other Study ID Numbers: NEU1640207B 
Study First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
REM Sleep Behavior Disorder
Mental Disorders
Pathologic Processes
REM Sleep Parasomnias
Sleep Wake Disorders
Nervous System Diseases processed this record on December 09, 2016