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Completed

NCT Number: NCT01401413

Study to Determine Whether Ramelteon Helps People With 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.

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Key information

Conditions

REM Sleep Behavior Disorder Mental Disorders Nervous System Diseases Parasomnias REM Sleep Parasomnias Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sleep Medicine Centers of WNY

West Seneca, New York, 14224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramelteon

Drug

8 mg nightly for 30 nights

Other names: rozerem

Placebo

Drug

placebo control i pill nightly for 30 nights

Primary outcomes

  1. Change in polysomnographic scores

    Time frame: 30 days

Secondary outcomes

  1. change in RBD symptom questionnaire and sleep diary

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Sleep Medicine Centers of WNY

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 25, 2011
Registry last updated
Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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