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

A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01401413

Enrollment

Registered

2011-07-25

Start date

2008-01-31

Completion date

2010-09-30

Last updated

2011-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

REM Sleep Behavior Disorder

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.

Interventions

DRUGramelteon

8 mg nightly for 30 nights

DRUGplacebo

placebo control i pill nightly for 30 nights

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Change in polysomnographic scores	30 days

Secondary

Measure	Time frame
change in RBD symptom questionnaire and sleep diary	30 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026