MedTrace Logo

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

NCT00868166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2020-02-25

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Olesoxime

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

DRUG

Placebo Comparator

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

DRUG

Riluzole

Riluzole given as add-on therapy 50mg bid

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868166 on ClinicalTrials.gov