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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00625547
First received: February 19, 2008
Last updated: October 28, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Restless Legs Syndrome
Drug: cabergoline
Drug: levodopa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • 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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RLS quality-of-life questionnaire [ Time Frame: Weeks 6 and 30 ] [ Designated as safety issue: No ]
  • Clinical Global Impression [ Time Frame: Weeks 6 and 30 ] [ Designated as safety issue: No ]
  • Patient Global Impression [ Time Frame: Weeks 6 and 30 ] [ Designated as safety issue: No ]
  • Sleep questionnaire form A [ Time Frame: Weeks 6 and 30 ] [ Designated as safety issue: No ]
  • IRLSSG-RS [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rating of severity of RLS at night (RLS-6 scale) [ Time Frame: Weeks 6 and 30 ] [ Designated as safety issue: No ]
  • Rating of severity of RLS before bedtime (RLS-6 scale) [ Time Frame: Weeks 6 and 30 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Global rating of quality of sleep (RLS-6 scale) [ Time Frame: Weeks 6 and 30 ] [ Designated as safety issue: No ]

Enrollment: 361
Study Start Date: January 2003
Study Completion Date: December 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625547

  Show 50 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00625547     History of Changes
Other Study ID Numbers: CABAS-0067-031
Study First Received: February 19, 2008
Last Updated: October 28, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Cabergoline
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014