- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01401413
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
July 22, 2011 updated by: Sleep Medicine Centers of WNY
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
West Seneca, New York, United States, 14224
- Sleep Medicine Centers of WNY
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
placebo control nightly
|
placebo control i pill nightly for 30 nights
|
Active Comparator: 2
8 mg ramelteon nightly
|
8 mg nightly for 30 nights
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in polysomnographic scores
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in RBD symptom questionnaire and sleep diary
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel I Rifkin, MD, Sleep Medicine Centers of Western New York
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
July 22, 2011
First Submitted That Met QC Criteria
July 22, 2011
First Posted (Estimate)
July 25, 2011
Study Record Updates
Last Update Posted (Estimate)
July 25, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU1640207B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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