drugset / Trial / NCT03053427

A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

NCT03053427

Phase 4 Completed 375 enrolled Astellas Pharma Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in participants with moderate-to-severe idiopathic restless legs syndrome. This study also assessed the safety of Gabapentin enacarbil.

Timeline

Start
2017-03-30
Primary completion
2018-06-25
Completion
2018-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject gabapentin enacarbil Small molecule 600 mg Oral