drugset / Trial / NCT00676403

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

NCT00676403 ↗

Phase 2 Completed 137 enrolled Viatris Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2008-04
Primary completion
2009-01
Completion
2009-01

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo vs Pregabalin 150 mg; p = 0.0013; Mean Difference (Final Values) -8.29 (95% CI -13.31 to -3.28); Mixed Models Analysis NCT00676403 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 50 mg —
Subject Pregabalin Small molecule 100 mg —
Subject Pregabalin Small molecule 150 mg —
Subject Pregabalin Small molecule 300 mg —
Subject Pregabalin Small molecule 450 mg —