CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
Olesoximedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02628743
NCT02628743Phase 2Completed
CompareCT.gov

Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Effectiveness of 10 mg/kg BID Olesoxime in Patients With Spinal Muscular Atrophy

Hoffmann-La Roche·interventional·Posted Dec 11, 2015·Updated Aug 9, 2019

In Brief

A Phase 2 clinical trial evaluating Olesoxime for Muscular Atrophy, Spinal. Completed, enrolled 131 participants across 24 sites in 7 countries.

Detailed 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 Spinal Muscular Atrophy (SMA) who previously participated in one of the following two clinical studies: TRO19622 CL E Q 1115-1 (open-label Phase Ib, multicenter, single- and multiple- dose study) or TRO19622 CL E Q 1275-1 (NCT01302600, Phase II/III, adaptive, parallel-group, double blind, randomized, placebo-controlled, multicenter, multinational study).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscular Atrophy, Spinal
CountriesBelgium, France, Germany, Italy, Netherlands, Poland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 11, 2015
Enrollment StartJan 20, 2016
Primary CompletionDec 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.6 years ago

Interventions

Olesoximedrug

Participants will receive homogeneous suspension of olesoxime.