Clinical Trial: A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Participants With Spinal Muscular Atrophy (SMA)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional




Official Title: Multicenter, Open-Label, Single Arm Study to Evaluate Long-Term Safety, Tolerability, and Effectiveness of 10 mg/kg Olesoxime in Patients With SMA

Brief Summary: The purpose of this open-label, single arm study is to further evaluate long-term tolerability, safety and efficacy outcomes of olesoxime in participants with SMA who previously participated in one of the following two clinical studies: TRO19622 CL E Q 1115-1 (NCT ID XXX, open-label Phase Ib, dose-ranged, single and multiple dose study) or TRO19622 CL E Q 1275-1 (NCT01302600, Phase II, multicenter, randomized, adaptive, double-blind, placebo controlled study).