12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

• Status: Withdrawn
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.

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

Details

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

Criteria

Inclusion Criteria:

• Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS:

• RLS symptoms occur predominantly in the evening

• RLS history at least 6 months

• International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in

• Have greater than or equal to 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