CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 512 enrolled
Drug / intervention
Olesoxime +2 moredrug
Likely dose
Olesoxime 330mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00868166
NCT00868166Phase 3Completed
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Phase II/III, Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) Patients Treated With Riluzole

Hoffmann-La Roche·interventional·Posted Mar 24, 2009·Updated Feb 25, 2020

In Brief

A Phase 3 clinical trial evaluating Olesoxime, Placebo Comparator, and 1 other intervention for Amyotrophic Lateral Sclerosis. Completed, enrolled 512 participants across 15 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesBelgium, France, Germany, Spain, United Kingdom
CollaboratorsEuropean Commission

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 24, 2009
Enrollment StartApr 30, 2009
Primary CompletionSep 30, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.3 years ago

Interventions

Olesoximedrug

2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid

Placebo Comparatordrug

2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid

Riluzoledrug

Riluzole given as add-on therapy 50mg bid