Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Restless Legs Syndrome

In brief

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.

Key facts

Study ID

NCT00806026

Run by

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

People needed

731

Starts

2008-12-01

Expected to finish

2011-05-01

Last updated by the study team

2021-01-26

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• Any secondary RLS
• Current augmentation due to RLS treatment
• Placebo responders identified during the placebo run-in

Where it is running

• Pfizer Investigational Site — Jasper, Alabama, United States
• Pfizer Investigational Site — Tuscaloosa, Alabama, United States
• Pfizer Investigational Site — Glendale, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Northridge, California, United States
• Pfizer Investigational Site — Redondo Beach, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Torrance, California, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Boca Raton, Florida, 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 — South Miami, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Baton Rouge, Louisiana, United States
• Pfizer Investigational Site — Chevy Chase, Maryland, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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