NCT01401413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

2.7 years

First QC Date

July 22, 2011

Last Update Submit

July 22, 2011

Conditions

REM Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in polysomnographic scores

    30 days

Secondary Outcomes (1)

  • change in RBD symptom questionnaire and sleep diary

    30 days

Study Arms (2)

1

PLACEBO COMPARATOR

placebo control nightly

Drug: placebo

2

ACTIVE COMPARATOR

8 mg ramelteon nightly

Drug: ramelteon

Interventions

ramelteonDRUG

8 mg nightly for 30 nights

Also known as: rozerem
2
placeboDRUG

placebo control i pill nightly for 30 nights

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for RBD as determined by screening PSG's
  • steady bed partner for completion of RBD questionnaire

You may not qualify if:

  • Hepatic impairment
  • RBD associated with narcolepsy
  • use of fluvoxamine, rifampin, fluconazole or ketoconazole
  • current alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Medicine Centers of WNY

West Seneca, New York, 14224, United States

Location

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Interventions

ramelteon

Condition Hierarchy (Ancestors)

REM Sleep ParasomniasParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Daniel I Rifkin, MD

    Sleep medicine Centers of Western New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2011

First Posted

July 25, 2011

Study Start

January 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

US(1)