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

Completed · Phase 3 · Has a placebo group

Conditions studied: Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT00991276

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

85

Starts

2009-12-01

Expected to finish

2011-06-01

Last updated by the study team

2021-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Jasper, Alabama, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Burlingame, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — Redlands, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Hallandale, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Pembroke Pines, Florida, United States
• Pfizer Investigational Site — Spring Hill, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Macon, Georgia, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Crestview Hills, Kentucky, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Baton Rouge, Louisiana, United States
• Pfizer Investigational Site — Chevy Chase, Maryland, United States
• Pfizer Investigational Site — Brighton, Massachusetts, United States

Full record on ClinicalTrials.gov

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