Status:
COMPLETED
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Idiopathic Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.
Eligibility Criteria
Inclusion
- idiopathic RLS with the presence of all four clinical manifestations of RLS
- RLS symptoms occur predominantly in the evening
- RLS history at least 6 months
- IRLS =\> 15 at the beginning and the end of placebo run-in
- Have =\>15 nights with RLS symptoms in the month prior to screening
Exclusion
- Any secondary RLS
- Current augmentation due to RLS treatment
- Placebo responders identified during the placebo run-in
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
731 Patients enrolled
Trial Details
Trial ID
NCT00806026
Start Date
December 1 2008
End Date
May 1 2011
Last Update
January 26 2021
Active Locations (110)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
2
Pfizer Investigational Site
Jasper, Alabama, United States, 35501
3
Pfizer Investigational Site
Tuscaloosa, Alabama, United States, 35406
4
Pfizer Investigational Site
Glendale, Arizona, United States, 85308