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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Innsbruck, , 6020 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Restless Legs Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Not available

NCT00625547
Pfizer
Completed
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Restless Legs Syndrome
  • 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
  • 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
  • Experimental: 1
    Intervention: Drug: cabergoline
  • Experimental: 2
    Intervention: Drug: levodopa
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
361
December 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Sweden,   Switzerland
 
 
NCT00625547
CABAS-0067-031
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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