Status:
COMPLETED
Study to Evaluate the Efficacy of Riluzole in Children and Young Adults With Spinal Muscular Atrophy (SMA)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
SMA
Eligibility:
All Genders
6-20 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a multicentric, randomized, double-blind study versus placebo, with two parallel groups treated to evaluate the efficacy and the tolerance of Riluzole in children and young adults (6 to 20 yea...
Detailed Description
ASIRI study should allow to evaluate the efficacy and the tolerance of Riluzole in children and young adults (6 to 20 years of age) with SMA. This is a multicentric, randomized, double-blind study ver...
Eligibility Criteria
Inclusion
- Patients afflicted with spinal muscular atrophy, type II or III, with genetic defect confirmed.
- Age between 6 and 20 years old.
- Score MFM at least 12
- Negative pregnancy test for women of child-bearing age
- Signing of an informed consent form, after appropriate information has been provided (if the patient is under 18 years old, both parents are required to sign the form too; otherwise, only her (his) agreement is necessary).
Exclusion
- Patients already treated with Riluzole
- Concomitant treatment with: GAPAPENTINE, DEXTROMETHORPHANE, amantadine, any hepatotoxic medication that cannot be stopped, any other experimental product
- Hepatic insufficiency: SGPT and/or SGOT levels higher than or equal to twice the normal higher limit
- Renal insufficiency (creatinine above 115 micromoles/l)
- Severe cardiac insufficiency
- Current pneumopathy (clinical signs of an acute episode, confirmed by pulmonary X-ray, requiring specific treatment)
- Pregnancy or nursing for women; non-abstinence or absence of effective contraception for nubile women
- Any pathology or other circumstance likely to interfere with a regular follow-up
- No affiliation to any social insurance system
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00774423
Start Date
January 1 2006
End Date
December 1 2011
Last Update
February 15 2013
Active Locations (1)
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1
Hopital Raymond Poincare
Garches, France, 92380