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

• ClinicalTrials.gov Identifier: NCT00625547
• Recruitment Status: Completed
• First Posted: February 28, 2008
• Last Update Posted: October 29, 2008
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: February 19, 2008
• First Posted Date: February 28, 2008
• Last Update Posted Date: October 29, 2008
• Study Start Date: January 2003
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: February 27, 2008)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 27, 2008)

• RLS quality-of-life questionnaire [ Time Frame: Weeks 6 and 30 ]
• Clinical Global Impression [ Time Frame: Weeks 6 and 30 ]
• Patient Global Impression [ Time Frame: Weeks 6 and 30 ]
• Sleep questionnaire form A [ Time Frame: Weeks 6 and 30 ]
• IRLSSG-RS [ Time Frame: 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 ]
• Rating of severity of RLS at night (RLS-6 scale) [ Time Frame: Weeks 6 and 30 ]
• Rating of severity of RLS before bedtime (RLS-6 scale) [ Time Frame: 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 ]
• Global rating of quality of sleep (RLS-6 scale) [ Time Frame: Weeks 6 and 30 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Restless Legs Syndrome

Intervention

• 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

Study Arms

• Experimental: 1
  Intervention: Drug: cabergoline
• Experimental: 2
  Intervention: Drug: levodopa

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 28, 2008): 361
• Original Actual Enrollment (submitted: February 27, 2008): 340
• Actual Study Completion Date: December 2004
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Sweden, Switzerland

Administrative Information

• NCT Number: NCT00625547
• Other Study ID Numbers: CABAS-0067-031
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2008