Trials / Completed
CompletedNCT02628743
A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olesoxime | Participants will receive homogeneous suspension of olesoxime. |
Timeline
- Start date
- 2016-01-20
- Primary completion
- 2018-12-18
- Completion
- 2018-12-18
- First posted
- 2015-12-11
- Last updated
- 2019-08-09
- Results posted
- 2019-08-09
Locations
24 sites across 7 countries: Belgium, France, Germany, Italy, Netherlands, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02628743. Inclusion in this directory is not an endorsement.