A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
NCT ID: NCT00627003
Last Updated: 2011-04-25
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
43 participants
INTERVENTIONAL
2002-11-30
2003-05-31
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 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
2
Placebo
Placebo oral tablets administered daily for 5 weeks
Interventions
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Cabergoline
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
Placebo
Placebo oral tablets administered daily for 5 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
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
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-0067-033
Identifier Type: -
Identifier Source: org_study_id
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