NCT00676403

Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	placebo	Placebo control (capsule), once a day, 1- 3 hours before bedtime for 6 weeks
DRUG	Pregabalin	50 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
DRUG	Pregabalin	100 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
DRUG	Pregabalin	150 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
DRUG	Pregabalin	300 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks
DRUG	Pregabalin	450 mg (capsule) per day, 1 - 3 hours before bedtime for 6 weeks

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-05-13
• Last updated: 2021-02-10
• Results posted: 2010-02-04

Locations

25 sites across 4 countries: United States, Austria, Germany, Spain