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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
Sleep Medicine Centers of WNY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for REM Sleep Behavior Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 22, 2011
Last Updated
July 22, 2011
Sponsor
Sleep Medicine Centers of WNY
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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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