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

F. Hoffmann-La Roche Ltd0 sites131 target enrollmentAugust 4, 2015

Overview

No summary available.

Registry

who.int

Start Date

August 4, 2015

End Date

December 18, 2018

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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