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

October 28, 2008 updated by: Pfizer

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
361

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Pfizer Investigational Site
      • Wien, Austria, A-1090
        • Pfizer Investigational Site
  • Germany
      • Altoetting, Germany, 84503
        • Pfizer Investigational Site
      • Aschaffenburg, Germany, 63739
        • Pfizer Investigational Site
      • Bad Honnef, Germany, 53604
        • Pfizer Investigational Site
      • Bad Saarow, Germany, 15526
        • Pfizer Investigational Site
      • Beckum, Germany, 49269
        • Pfizer Investigational Site
      • Berlin, Germany, 10969
        • Pfizer Investigational Site
      • Berlin, Germany, 12163
        • Pfizer Investigational Site
      • Berlin, Germany, 12687
        • Pfizer Investigational Site
      • Berlin, Germany, 13053
        • Pfizer Investigational Site
      • Berlin, Germany, 13507
        • Pfizer Investigational Site
      • Bochum, Germany
        • Pfizer Investigational Site
      • Bremerhaven, Germany, 27568
        • Pfizer Investigational Site
      • Dillingen, Germany, 66763
        • Pfizer Investigational Site
      • Duesseldorf, Germany, 40211
        • Pfizer Investigational Site
      • Duisburg, Germany
        • Pfizer Investigational Site
      • Gelsenkirchen, Germany, 45891
        • Pfizer Investigational Site
      • Gera, Germany, 0755
        • Pfizer Investigational Site
      • Goettingen, Germany, 37075
        • Pfizer Investigational Site
      • Goettingen, Germany, 37037
        • Pfizer Investigational Site
      • Halle, Germany, 06118
        • Pfizer Investigational Site
      • Hamburg, Germany, 22359
        • Pfizer Investigational Site
      • Heilbronn, Germany, 74072
        • Pfizer Investigational Site
      • Jena, Germany
        • Pfizer Investigational Site
      • Kaiserslautern, Germany, 67655
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76137
        • Pfizer Investigational Site
      • Karlsruhe, Germany
        • Pfizer Investigational Site
      • Kassel, Germany, 34128
        • Pfizer Investigational Site
      • Köthen, Germany
        • Pfizer Investigational Site
      • Marburg, Germany, 35039
        • Pfizer Investigational Site
      • Mittweida, Germany, 09648
        • Pfizer Investigational Site
      • Moenchengladbach, Germany, 41179
        • Pfizer Investigational Site
      • Neubrandenburg, Germany, 17033
        • Pfizer Investigational Site
      • Oldenburg, Germany, 26122
        • Pfizer Investigational Site
      • Quickborn, Germany, 25451
        • Pfizer Investigational Site
      • Regensburg, Germany, 93053
        • Pfizer Investigational Site
      • Schwalmstadt, Germany, 34613
        • Pfizer Investigational Site
      • Schwerin, Germany, 19055
        • Pfizer Investigational Site
      • Stuttgart, Germany, 70176
        • Pfizer Investigational Site
      • Tuttlingen, Germany, 78532
        • Pfizer Investigational Site
      • Ulm, Germany, 89073
        • Pfizer Investigational Site
      • Wiesbaden, Germany, 65191
        • Pfizer Investigational Site
      • Wolfsburg, Germany
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, S-413 45
        • Pfizer Investigational Site
      • Karlstad, Sweden
        • Pfizer Investigational Site
      • Linköping, Sweden, 581 85
        • Pfizer Investigational Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Pfizer Investigational Site
      • Bern, Switzerland
        • Pfizer Investigational Site
      • Zürich, Switzerland, CH-8091
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: cabergoline
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
Experimental: 2
Drug: levodopa
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)
Time Frame: Week 6
Week 6
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
RLS quality-of-life questionnaire
Time Frame: Weeks 6 and 30
Weeks 6 and 30
Clinical Global Impression
Time Frame: Weeks 6 and 30
Weeks 6 and 30
Patient Global Impression
Time Frame: Weeks 6 and 30
Weeks 6 and 30
Sleep questionnaire form A
Time Frame: Weeks 6 and 30
Weeks 6 and 30
IRLSSG-RS
Time Frame: Week 30
Week 30
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
Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2
Rating of severity of RLS at night (RLS-6 scale)
Time Frame: Weeks 6 and 30
Weeks 6 and 30
Rating of severity of RLS before bedtime (RLS-6 scale)
Time Frame: Weeks 6 and 30
Weeks 6 and 30
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
Weeks 6 and 30
Global rating of quality of sleep (RLS-6 scale)
Time Frame: Weeks 6 and 30
Weeks 6 and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CABAS-0067-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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