A Study to Evaluate the Efficacy and Safety of Cabergolin... | NCT00627003

Studies
A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

NCT00627003

Sponsor

Pfizer

Status

Completed

Last Update Posted

Apr 25, 2011Estimated

Enrollment

43Actual

Phase

Phase 3

Conditions

Restless Legs Syndrome

Interventions

Cabergoline
Placebo

Countries

Not provided

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

Apr 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

Nov 2002

Primary Completion Date

Not provided

Completion Date

May 2003Actual

First Submitted Date

Feb 19, 2008

First Submission Date that Met QC Criteria

Feb 19, 2008

First Posted Date

Feb 29, 2008Estimated

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

Apr 22, 2011

Last Update Posted Date

Apr 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 evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Cabergoline
2	Experimental		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cabergoline	Drug	Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep efficiency		Week 5
PLMS-arousal index (PLMS-AI)		Week 5

Secondary Outcomes

Measure	Description	Time Frame
Sleep Questionnaire Form A		Weeks 2 and 5
Quality of Life for RLS questionnaire		Weeks 2 and 5
Clinical Global Impressions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Idiopathic RLS
Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time

Exclusion Criteria:

Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D012148	Restless Legs Syndrome

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077465	Cabergoline

Ancestor Terms

ID	Term
D004873	Ergolines
D004876	Ergot Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided