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

NCT00625547 | Completed Phase 3

• 1 other identifier: CABAS-0067-031
• Study Type: interventional
• Target: 361
• Locations: 4 countries
• Sites: 50

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.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

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

  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 Outcomes (10)

• RLS quality-of-life questionnaire

  Weeks 6 and 30

• Clinical Global Impression

  Weeks 6 and 30

• Patient Global Impression

  Weeks 6 and 30

• Sleep questionnaire form A

  Weeks 6 and 30

• IRLSSG-RS

  Week 30

Study Arms (2)

1

EXPERIMENTAL

Drug: cabergoline

2

EXPERIMENTAL

Drug: levodopa

Interventions

cabergoline DRUG

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

1

levodopa DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not available

Sponsors & Collaborators

• Pfizer: lead

Study Sites (50)

Pfizer Investigational Site

Innsbruck, 6020, Austria

Location

Pfizer Investigational Site

Vienna, A-1090, Austria

Location

Pfizer Investigational Site

Altötting, 84503, Germany

Location

Pfizer Investigational Site

Aschaffenburg, 63739, Germany

Location

Pfizer Investigational Site

Bad Honnef, 53604, Germany

Location

Pfizer Investigational Site

Bad Saarow, 15526, Germany

Location

Pfizer Investigational Site

Beckum, 49269, Germany

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Pfizer Investigational Site

Berlin, 10969, Germany

Location

Pfizer Investigational Site

Berlin, 12163, Germany

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Pfizer Investigational Site

Berlin, 12687, Germany

Location

Pfizer Investigational Site

Berlin, 13053, Germany

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Pfizer Investigational Site

Berlin, 13507, Germany

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Pfizer Investigational Site

Bochum, Germany

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Pfizer Investigational Site

Bremerhaven, 27568, Germany

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Pfizer Investigational Site

Dillingen, 66763, Germany

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Duisburg, Germany

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Pfizer Investigational Site

Düsseldorf, 40211, Germany

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Gelsenkirchen, 45891, Germany

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Pfizer Investigational Site

Gera, 0755, Germany

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Pfizer Investigational Site

Göttingen, 37037, Germany

Location

Pfizer Investigational Site

Göttingen, 37075, Germany

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Pfizer Investigational Site

Halle, 06118, Germany

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Pfizer Investigational Site

Hamburg, 22359, Germany

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Pfizer Investigational Site

Heilbronn, 74072, Germany

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Pfizer Investigational Site

Jena, Germany

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Pfizer Investigational Site

Kaiserslautern, 67655, Germany

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Karlsruhe, 76137, Germany

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Pfizer Investigational Site

Karlsruhe, Germany

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Pfizer Investigational Site

Kassel, 34128, Germany

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Pfizer Investigational Site

Köthen, Germany

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Pfizer Investigational Site

Marburg, 35039, Germany

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Pfizer Investigational Site

Mittweida, 09648, Germany

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Pfizer Investigational Site

Mönchengladbach, 41179, Germany

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Pfizer Investigational Site

Neubrandenburg, 17033, Germany

Location

Pfizer Investigational Site

Oldenburg, 26122, Germany

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Pfizer Investigational Site

Quickborn, 25451, Germany

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Pfizer Investigational Site

Regensburg, 93053, Germany

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Pfizer Investigational Site

Schwalmstadt, 34613, Germany

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Pfizer Investigational Site

Schwerin, 19055, Germany

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Pfizer Investigational Site

Stuttgart, 70176, Germany

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Pfizer Investigational Site

Tuttlingen, 78532, Germany

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Pfizer Investigational Site

Ulm, 89073, Germany

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Pfizer Investigational Site

Wiesbaden, 65191, Germany

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Pfizer Investigational Site

Wolfsburg, Germany

Location

Pfizer Investigational Site

Gothenburg, S-413 45, Sweden

Location

Pfizer Investigational Site

Karlstad, Sweden

Location

Pfizer Investigational Site

Linköping, 581 85, Sweden

Location

Pfizer Investigational Site

Basel, Basel, 4031, Switzerland

Location

Pfizer Investigational Site

Bern, Canton of Bern, Switzerland

Location

Pfizer Investigational Site

Zurich, CH-8091, Switzerland

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Cabergoline; Levodopa

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: January 1, 2003
• Study Completion: December 1, 2004
• Last Updated: October 29, 2008

Record last verified: 2008-10

Locations

DE (42); AU (2); CH (3); SE (3)