deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT02628743

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

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

Sponsor: Hoffmann-La Roche

Conditions Muscular Atrophy, Spinal
Interventions Olesoxime
Updated 17 times since 2017 Last updated: Jul 18, 2019 Started: Jan 20, 2016 Primary completion: Dec 18, 2018 Completion: Dec 18, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02628743, this PHASE2 trial focuses on Muscular Atrophy, Spinal and remains completed. Sponsored by Hoffmann-La Roche, it has been updated 17 times since 2016, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Dec 2017 · 6 months · monthly snapshot~Dec 2017 – ~Apr 2018 · 4 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Mar 2019 · 4 months · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Sep 2019 · 5 months · monthly snapshot~Sep 2019 – ~Jan 2021 · 16 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Sep 2019 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 12 earlier versions

  1. Apr 2019 — Sep 2019 [monthly]

    Completed PHASE2

  2. Mar 2019 — Apr 2019 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  3. Nov 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE2

  5. Aug 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE2

  6. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE2

  7. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE2

  8. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

  9. Dec 2017 — Apr 2018 [monthly]

    Active Not Recruiting PHASE2

  10. Jun 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  11. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE2

  12. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Jan 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hoffmann-La Roche
Data source: Hoffmann-La Roche

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Birmingham, United Kingdom , Bron, France , Essen, Germany , Freiburg im Breisgau, Germany , Garches, France , Genoa, Italy , Ghent, Belgium , Leuven, Belgium , Lille, France , London, United Kingdom and 11 more locations