Study to Determine Whether Ramelteon Helps People With RE... | NCT01401413

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

NCT01401413

Sponsor

Sleep Medicine Centers of WNY

Status

Completed

Last Update Posted

Jul 25, 2011Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

REM Sleep Behavior Disorder

Interventions

ramelteon
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jul 22, 2011

First Submission Date that Met QC Criteria

Jul 22, 2011

First Posted Date

Jul 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2011

Last Update Posted Date

Jul 25, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	placebo control nightly	Drug: placebo
2	Active Comparator	8 mg ramelteon nightly	Drug: ramelteon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ramelteon	Drug	8 mg nightly for 30 nights	2	rozerem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in polysomnographic scores		30 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel I Rifkin, MD	Sleep medicine Centers of Western New York	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sleep Medicine Centers of WNY		West Seneca	New York	14224	United States

Condition Browse Module

MeSH Terms

ID	Term
D020187	REM Sleep Behavior Disorder

Ancestor Terms

ID	Term
D020923	REM Sleep Parasomnias
D020447	Parasomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C495910	ramelteon

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided