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

Sleep Medicine Centers of WNY

Status and phase: Completed; Phase 4

Conditions: REM Sleep Behavior Disorder

Treatments: Drug: placebo; Drug: ramelteon

Study type: Interventional

Funder types: Other

Identifiers

NCT01401413

NEU1640207B

Details and patient eligibility

About

The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo control nightly

Treatment:

Drug: placebo

2

Active Comparator group

Description:

8 mg ramelteon nightly

Treatment:

Drug: ramelteon