MedTrace Logo

Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Years SMA Patients.

NCT01302600 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2016-11-22

No results posted yet for this study

Summary

Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients aged 3-25 years

Conditions

  • Spinal Muscular Atrophy Type II
  • Spinal Muscular Atrophy Type III Non Ambulant

Interventions

DRUG

Olesoxime

Liquid suspension formulation, 100 mg/ml at a dose of 10 mg/kg will be administered once a day with food at dinner

DRUG

Placebo

0.1ml/kg once a day with food at dinner.

Sponsors & Collaborators

  • Association Française contre les Myopathies (AFM), Paris

    collaborator OTHER

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Enrico Bertini, MD · Bambino Gesu Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01302600 on ClinicalTrials.gov