drugset / Trial / NCT00868166

Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS

NCT00868166

Phase 3 Completed 512 enrolled Hoffmann-La Roche European Commission · collab
RandomizedParallel-groupQuadruple-blindOther

Summary

The purpose of the assay is to assess the safety and the efficacy of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo, assessed by the 18-month survival rate.

Timeline

Start
2009-04-30
Primary completion
2011-09-30
Completion
2011-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Olesoxime Small molecule 330 mg Oral
Background Riluzole Small molecule 50 mg