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Safety Extension Study of TRO19622 in ALS

NCT01285583 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2016-11-22

No results posted yet for this study

Summary

The purpose of the assay is to assess the safety of TRO19622 330 mg QD as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, after completion of the preceding clinical trial (TRO19622 CL E Q 1015-1) in an open label extension.

Conditions

Interventions

DRUG

TRO19622

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

Sponsors & Collaborators

Principal Investigators

  • Vincent Meininger, MD, PhD · Groupe Hospitalier Pitie-Salpetriere

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Belgium
  • France
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01285583 on ClinicalTrials.gov