EUCTR2015-001589-25-NL
Active, not recruiting
Phase 1
Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg BID olesoxime in patients with Spinal Muscular Atrophy - OLEOS
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Spinal Muscular Atrophy
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 131
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participation in the previous studies (TRO19622CLEQ11150\-1 or TRO19622CLEQ1275\-1\)
- •Able to comply with the study protocol, in the investigator’s judgment, including ability to take study treatment and perform study visits
- •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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 117
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 56
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Patients who, in the opinion of the investigator, are not suitable to participate in this open label study
- •Patients who have developed study drug hypersensitivity to olesoxime or one of the formulation excipients, including sesame oil
- •Concomitant or previous participation in any other investigational drug or device study within 90 days prior to screening
- •Concomitant or previous participation in a survival motor neuron protein gene (SMN2\) targeting antisense oligonucleotide study within 6 months prior to screening
- •Pregnant or lactating, or intending to become pregnant during the study
Outcomes
Primary Outcomes
Not specified
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