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Eine Studie zur Beurteilung der Langzeitsicherheit, Verträglichkeit und Wirksamkeit von Olesoxim bei Patient*innen mit spinaler Muskelatrophie (SMA)
A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)
- Erkrankung der Muskeln und peripheren Nerven
- Spinale Muskelatrophie (SMA)
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Essen
- Freiburg im Breisgau
- München
Studien-ID:
NCT02628743 2015-001589-25 BN29854
Studienzusammenfassung
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).
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT02628743,BN29854,2015-001589-25
Studien-ID
Olesoxime
Treatments
Muscular Atrophy, Spinal
Condition
Official Title
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
Einschlusskriterien
All
Gender
No
Healthy Volunteers
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
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