Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• 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:

• 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 Criteria:

• Any secondary RLS

• Current augmentation due to RLS treatment

• Placebo responders identified during the placebo run-in