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A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Primary Purpose

Restless Legs Syndrome

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

cabergoline

levodopa

About this trial

This is an interventional treatment trial for Restless Legs Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS
Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale
No previous treatment for RLS or dissatisfaction with their current therapy

Exclusion Criteria:

Not available

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)

Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period)

Secondary Outcome Measures

RLS quality-of-life questionnaire

Clinical Global Impression

Patient Global Impression

Sleep questionnaire form A

IRLSSG-RS

Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram

Rating of severity of RLS at night (RLS-6 scale)

Rating of severity of RLS before bedtime (RLS-6 scale)

Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)

Global rating of quality of sleep (RLS-6 scale)

Full Information

NCT ID

NCT00625547

First Posted

February 19, 2008

Last Updated

October 28, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00625547

Brief Title

A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Official Title

A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

361 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

cabergoline

Intervention Description

Cabergoline oral tablets: 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 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events

Intervention Type

Drug

Intervention Name(s)

levodopa

Intervention Description

Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events

Primary Outcome Measure Information:

Title

Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)

Time Frame

Week 6

Title

Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period)

Secondary Outcome Measure Information:

Title

RLS quality-of-life questionnaire

Time Frame

Weeks 6 and 30

Title

Clinical Global Impression

Time Frame

Weeks 6 and 30

Title

Patient Global Impression

Time Frame

Weeks 6 and 30

Title

Sleep questionnaire form A

Time Frame

Weeks 6 and 30

Title

IRLSSG-RS

Time Frame

Week 30

Title

Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram

Time Frame

Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2

Title

Rating of severity of RLS at night (RLS-6 scale)

Time Frame

Weeks 6 and 30

Title

Rating of severity of RLS before bedtime (RLS-6 scale)

Time Frame

Weeks 6 and 30

Title

Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)

Time Frame

Weeks 6 and 30

Title

Global rating of quality of sleep (RLS-6 scale)

Time Frame

Weeks 6 and 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale No previous treatment for RLS or dissatisfaction with their current therapy Exclusion Criteria: Not available

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Pfizer Investigational Site

City

Wien

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

Pfizer Investigational Site

City

Altoetting

ZIP/Postal Code

84503

Country

Germany

Facility Name

Pfizer Investigational Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bad Honnef

ZIP/Postal Code

53604

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bad Saarow

ZIP/Postal Code

15526

Country

Germany

Facility Name

Pfizer Investigational Site

City

Beckum

ZIP/Postal Code

49269

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12687

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

13053

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

13507

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bochum

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bremerhaven

ZIP/Postal Code

27568

Country

Germany

Facility Name

Pfizer Investigational Site

City

Dillingen

ZIP/Postal Code

66763

Country

Germany

Facility Name

Pfizer Investigational Site

City

Duesseldorf

ZIP/Postal Code

40211

Country

Germany

Facility Name

Pfizer Investigational Site

City

Duisburg

Country

Germany

Facility Name

Pfizer Investigational Site

City

Gelsenkirchen

ZIP/Postal Code

45891

Country

Germany

Facility Name

Pfizer Investigational Site

City

Gera

ZIP/Postal Code

0755

Country

Germany

Facility Name

Pfizer Investigational Site

City

Goettingen

ZIP/Postal Code

37037

Country

Germany

Facility Name

Pfizer Investigational Site

City

Goettingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Pfizer Investigational Site

City

Halle

ZIP/Postal Code

06118

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

22359

Country

Germany

Facility Name

Pfizer Investigational Site

City

Heilbronn

ZIP/Postal Code

74072

Country

Germany

Facility Name

Pfizer Investigational Site

City

Jena

Country

Germany

Facility Name

Pfizer Investigational Site

City

Kaiserslautern

ZIP/Postal Code

67655

Country

Germany

Facility Name

Pfizer Investigational Site

City

Karlsruhe

ZIP/Postal Code

76137

Country

Germany

Facility Name

Pfizer Investigational Site

City

Karlsruhe

Country

Germany

Facility Name

Pfizer Investigational Site

City

Kassel

ZIP/Postal Code

34128

Country

Germany

Facility Name

Pfizer Investigational Site

City

Köthen

Country

Germany

Facility Name

Pfizer Investigational Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Pfizer Investigational Site

City

Mittweida

ZIP/Postal Code

09648

Country

Germany

Facility Name

Pfizer Investigational Site

City

Moenchengladbach

ZIP/Postal Code

41179

Country

Germany

Facility Name

Pfizer Investigational Site

City

Neubrandenburg

ZIP/Postal Code

17033

Country

Germany

Facility Name

Pfizer Investigational Site

City

Oldenburg

ZIP/Postal Code

26122

Country

Germany

Facility Name

Pfizer Investigational Site

City

Quickborn

ZIP/Postal Code

25451

Country

Germany

Facility Name

Pfizer Investigational Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Pfizer Investigational Site

City

Schwalmstadt

ZIP/Postal Code

34613

Country

Germany

Facility Name

Pfizer Investigational Site

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Pfizer Investigational Site

City

Stuttgart

ZIP/Postal Code

70176

Country

Germany

Facility Name

Pfizer Investigational Site

City

Tuttlingen

ZIP/Postal Code

78532

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wolfsburg

Country

Germany

Facility Name

Pfizer Investigational Site

City

Goteborg

ZIP/Postal Code

S-413 45

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Karlstad

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Linköping

ZIP/Postal Code

581 85

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Bern

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Zürich

ZIP/Postal Code

CH-8091

Country

Switzerland

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CABAS-0067-031&StudyName=A%20study%20to%20determine%20the%20efficacy%20and%20safety%20of%20cabergoline%20for%20the%20treatment%20of%20patients%20with%20RLS

Description

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Learn more about this trial

A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

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A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Restless Legs Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial