Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pramipexole; Pregabalin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.