12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
NCT ID: NCT01061372
Last Updated: 2021-01-22
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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WITHDRAWN
PHASE3
INTERVENTIONAL
2010-05-31
2011-08-31
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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Placebo
Placebo
Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
Pregabalin 150 mg/day
pregabalin
pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
Pregabalin 300 mg/day
pregabalin
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
Interventions
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Placebo
Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks
pregabalin
pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
pregabalin
pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* RLS symptoms occur predominantly in the evening
* RLS history at least 6 months
* International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in
* Have greater than or equal to 15 nights with RLS symptoms in the month prior to screening
Exclusion Criteria
* Current augmentation due to RLS treatment
* Placebo responders identified during the placebo run-in
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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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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A0081184
Identifier Type: -
Identifier Source: org_study_id
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