Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
NCT ID: NCT01401413
Last Updated: 2011-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2008-01-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
placebo control nightly
placebo
placebo control i pill nightly for 30 nights
2
8 mg ramelteon nightly
ramelteon
8 mg nightly for 30 nights
Interventions
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ramelteon
8 mg nightly for 30 nights
placebo
placebo control i pill nightly for 30 nights
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* steady bed partner for completion of RBD questionnaire
Exclusion Criteria
* RBD associated with narcolepsy
* use of fluvoxamine, rifampin, fluconazole or ketoconazole
* current alcohol or drug abuse
18 Years
80 Years
ALL
No
Sponsors
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Sleep Medicine Centers of WNY
OTHER
Responsible Party
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President
Principal Investigators
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Daniel I Rifkin, MD
Role: PRINCIPAL_INVESTIGATOR
Sleep medicine Centers of Western New York
Locations
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Sleep Medicine Centers of WNY
West Seneca, New York, United States
Countries
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Other Identifiers
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NEU1640207B
Identifier Type: -
Identifier Source: org_study_id
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