Status:
COMPLETED
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
Eligibility Criteria
Inclusion
- Diagnosis of restless legs syndrome with a total score of 15 or more points on the International RLS rating scale (IRLS).
- RLS symptoms interfering with sleep on 3 or more nights per week for at least 6 months.
- PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time of at least 3 hrs and less than 6.5 hrs.
Exclusion
- Secondary RLS.
- Daytime RLS symptoms requiring treatment.
- Primary sleep disorder.
- Sleep apnea.
- Night or shift work.
- Concurrent medical disorder that could interfere with efficacy assessment or present a safety concern.
- Pregnant or lactating women.
- Women of child-bearing potential not using acceptable method of birth control.
- Use of prohibited medication.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00991276
Start Date
December 1 2009
End Date
June 1 2011
Last Update
February 15 2021
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Jasper, Alabama, United States, 35501
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85037
3
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
4
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205