Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

Phase 3 Completed 731 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2008-12
Primary completion: 2011-05
Completion: 2011-05

Outcome

Mixed primary results

registry analysis (unspecified test); Pregabalin 300 mg vs Placebo; p <0.0001; Least squares (LS) mean difference -4.50 (95% CI -5.90 to -3.20); Mixed Models Analysis NCT00806026 ↗

registry analysis (unspecified test); Pregabalin 300 mg vs Placebo; p <0.0001; Cochran-Mantel-Haenszel NCT00806026 ↗

registry analysis (unspecified test); Pregabalin 300 mg vs Pramipexole 0.25 mg; p = 0.0826; Log Rank NCT00806026 ↗

Publications

Allen RP, Chen C, Garcia-Borreguero D, Polo O, DuBrava S, Miceli J, Knapp L, Winkelman JW. Comparison of pregabalin with pramipexole for restless legs syndrome. N Engl J Med. 2014 Feb 13;370(7):621-31. doi: 10.1056/NEJMoa1303646.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Pramipexole	Unknown	0.25 mg	Oral
Comparator	Pramipexole	Unknown	0.5 mg	Oral
Subject	Pregabalin	Small molecule	300 mg	Oral