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Sponsor: Hoffmann-La Roche
Conditions: Muscular Atrophy, Spinal
Interventions: Olesoxime
Countries: Belgium, France, Germany, Italy, Netherlands, Poland, United Kingdom
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).
Sex: ALL
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Participation in the previous studies (TRO19622 CL E Q 1115-1 or TRO19622 CL E Q 1275-1) * For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 28 days after the last dose of olesoxime Exclusion Criteria: * Female participants who are pregnant or lactating, or intending to become pregnant during the study * Participants who, in the opinion of the investigator, are not suitable to participate in this open-label study * Participants who have developed study drug hypersensitivity to olesoxime or one of the formulation excipients, including sesame oil * Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening * Concomitant or previous participation in a survival motor neuron 2 (SMN2) targeting antisense oligonucleotide study within 6 months prior to screening * History of human immunodeficiency virus infection, history of Hepatitis B infection within the past year, history of Hepatitis C infection which has not been adequately treated * History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study * History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion
- Ghent, Belgium
- Leuven, Belgium
- Bron, France
- Garches, France
- Lille, France
- Marseille, France
- Montpellier, France
- Paris, France
- Toulouse, France
- Essen, Germany
- Freiburg im Breisgau, Germany
- München, Germany
- Rome, Lazio, Italy
- Rome, Lazio, Italy
- Genoa, Liguria, Italy
- Milan, Lombardy, Italy
- Milan, Lombardy, Italy
- Messina, Sicily, Italy
- Utrecht, Netherlands
- Warsaw, Poland
- Birmingham, United Kingdom
- London, United Kingdom
- London, United Kingdom
- Newcastle upon Tyne, United Kingdom