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Clinical Trials/NL-OMON43897
NL-OMON43897
Completed
Phase 2

Multicenter, open-label, single arm study to evaluate long-term safety, tolerability, and effectiveness of 10mg/kg olesoxime in patients with SMA - BN29854

Roche Nederland B.V.0 sites9 target enrollmentTBD
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ConditionsDisease of muscles and nerves100283961002830210029317

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Disease of muscles and nerves
Sponsor
Roche Nederland B.V.
Enrollment
9
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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 last dose of olesoxime.

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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