Back to resultsA Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
Primary Purpose
Restless Legs Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cabergoline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Restless Legs Syndrome
Eligibility Criteria
Inclusion Criteria:
- Idiopathic RLS
- Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
- In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time
Exclusion Criteria:
- Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Sleep efficiency
PLMS-arousal index (PLMS-AI)
Secondary Outcome Measures
Sleep Questionnaire Form A
Quality of Life for RLS questionnaire
Clinical Global Impressions
Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography
Total score of the severity rating scale of the International RLS (IRLS) Study Group
RLS-6 severity scales
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00627003
Brief Title
A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
Official Title
A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Intervention Description
Cabergoline oral tablets administered once daily in the evening: 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, followed by a stable dose for an additional 3 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo oral tablets administered daily for 5 weeks
Primary Outcome Measure Information:
Title
Sleep efficiency
Time Frame
Week 5
Title
PLMS-arousal index (PLMS-AI)
Time Frame
Week 5
Secondary Outcome Measure Information:
Title
Sleep Questionnaire Form A
Time Frame
Weeks 2 and 5
Title
Quality of Life for RLS questionnaire
Time Frame
Weeks 2 and 5
Title
Clinical Global Impressions
Time Frame
Weeks 2 and 5
Title
Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography
Time Frame
Weeks 2 and 5
Title
Total score of the severity rating scale of the International RLS (IRLS) Study Group
Time Frame
Weeks 2 and 5
Title
RLS-6 severity scales
Time Frame
Weeks 2 and 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic RLS
Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time
Exclusion Criteria:
Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CABAS-0067-033&StudyName=A%20study%20to%20evaluate%20the%20efficacy%20and%20safety%20of%20cabergoline%20compared%20with%20placebo%20for%20the%20treatment%20of%20RLS%20
Description
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A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
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