drugset / Trial / NCT00530530

ASP8825 - Study in Patients With Restless Legs Syndrome

NCT00530530 ↗

Phase 2 Completed 474 enrolled Astellas Pharma Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome

Timeline

Start
2007-09
Primary completion
2009-01
Completion
2009-01

Outcome

Met primary endpoint

paper Williams' multiple comparison test showed that only 1200 mg GEn was superior to placebo (p = 0.011). PMID 23121149 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject gabapentin enacarbil Small molecule 600 mg Oral
Subject gabapentin enacarbil Small molecule 900 mg Oral
Subject gabapentin enacarbil Small molecule 1200 mg Oral