A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
NCT ID: NCT00625547
Last Updated: 2008-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
361 participants
INTERVENTIONAL
2003-01-31
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
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
2
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Innsbruck, , Austria
Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Altötting, , Germany
Pfizer Investigational Site
Aschaffenburg, , Germany
Pfizer Investigational Site
Bad Honnef, , Germany
Pfizer Investigational Site
Bad Saarow, , Germany
Pfizer Investigational Site
Beckum, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Bochum, , Germany
Pfizer Investigational Site
Bremerhaven, , Germany
Pfizer Investigational Site
Dillingen, , Germany
Pfizer Investigational Site
Duisburg, , Germany
Pfizer Investigational Site
Düsseldorf, , Germany
Pfizer Investigational Site
Gelsenkirchen, , Germany
Pfizer Investigational Site
Gera, , Germany
Pfizer Investigational Site
Göttingen, , Germany
Pfizer Investigational Site
Göttingen, , Germany
Pfizer Investigational Site
Halle, , Germany
Pfizer Investigational Site
Hamburg, , Germany
Pfizer Investigational Site
Heilbronn, , Germany
Pfizer Investigational Site
Jena, , Germany
Pfizer Investigational Site
Kaiserslautern, , Germany
Pfizer Investigational Site
Karlsruhe, , Germany
Pfizer Investigational Site
Karlsruhe, , Germany
Pfizer Investigational Site
Kassel, , Germany
Pfizer Investigational Site
Köthen, , Germany
Pfizer Investigational Site
Marburg, , Germany
Pfizer Investigational Site
Mittweida, , Germany
Pfizer Investigational Site
Mönchengladbach, , Germany
Pfizer Investigational Site
Neubrandenburg, , Germany
Pfizer Investigational Site
Oldenburg, , Germany
Pfizer Investigational Site
Quickborn, , Germany
Pfizer Investigational Site
Regensburg, , Germany
Pfizer Investigational Site
Schwalmstadt, , Germany
Pfizer Investigational Site
Schwerin, , Germany
Pfizer Investigational Site
Stuttgart, , Germany
Pfizer Investigational Site
Tuttlingen, , Germany
Pfizer Investigational Site
Ulm, , Germany
Pfizer Investigational Site
Wiesbaden, , Germany
Pfizer Investigational Site
Wolfsburg, , Germany
Pfizer Investigational Site
Gothenburg, , Sweden
Pfizer Investigational Site
Karlstad, , Sweden
Pfizer Investigational Site
Linköping, , Sweden
Pfizer Investigational Site
Basel, Basel, Switzerland
Pfizer Investigational Site
Bern, Canton of Bern, Switzerland
Pfizer Investigational Site
Zurich, , Switzerland
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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CABAS-0067-031
Identifier Type: -
Identifier Source: org_study_id