Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
Primary Purpose
REM Sleep Behavior Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ramelteon
placebo
Sponsored by
About this trial
This is an interventional treatment trial for REM Sleep Behavior Disorder
Eligibility 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
Sites / Locations
- Sleep Medicine Centers of WNY
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
1
2
Arm Description
placebo control nightly
8 mg ramelteon nightly
Outcomes
Primary Outcome Measures
Change in polysomnographic scores
Secondary Outcome Measures
change in RBD symptom questionnaire and sleep diary
Full Information
NCT ID
NCT01401413
First Posted
July 22, 2011
Last Updated
July 22, 2011
Sponsor
Sleep Medicine Centers of WNY
1. Study Identification
Unique Protocol Identification Number
NCT01401413
Brief Title
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
Official Title
A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sleep Medicine Centers of WNY
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REM Sleep Behavior Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo control nightly
Arm Title
2
Arm Type
Active Comparator
Arm Description
8 mg ramelteon nightly
Intervention Type
Drug
Intervention Name(s)
ramelteon
Other Intervention Name(s)
rozerem
Intervention Description
8 mg nightly for 30 nights
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo control i pill nightly for 30 nights
Primary Outcome Measure Information:
Title
Change in polysomnographic scores
Time Frame
30 days
Secondary Outcome Measure Information:
Title
change in RBD symptom questionnaire and sleep diary
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel I Rifkin, MD
Organizational Affiliation
Sleep medicine Centers of Western New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Medicine Centers of WNY
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
12. IPD Sharing Statement
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Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
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