A Study to Evaluate Long Term Safety, Tolerability, and Effectiveness of Olesoxime in Patients With Spinal Muscular Atrophy (SMA)

  • Spinal Muscular Atrophy (SMA)
Trial Status:

Completed

This trial runs in
Countries
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • United Kingdom
Trial Identifier:

NCT02628743 2015-001589-25 BN29854

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      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 Trial Identifier
      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

      Eligibility Criteria

      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

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now