deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT03461289

Single-Dose Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1 (STRIVE-EU)

Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

Sponsor: Novartis Gene Therapies

Conditions SMA
Interventions Onasemnogene Abeparvovec-xioi
Updated 27 times since 2018 Last updated: Jan 7, 2026 Started: Aug 16, 2018 Primary completion: Sep 11, 2020 Completion: Sep 11, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates SMA and is currently completed. Novartis Gene Therapies leads this study, which shows 27 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Jan 2019 · 2 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~Oct 2020 · 6 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Jun 2022 · 13 months · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

27 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Feb 2026 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 22 earlier versions

  1. Jun 2022 — Sep 2022 [monthly]

    Completed PHASE3

  2. May 2021 — Jun 2022 [monthly]

    Completed PHASE3

  3. Jan 2021 — May 2021 [monthly]

    Completed PHASE3

  4. Oct 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  5. Apr 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  6. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE3

  7. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE3

  8. Dec 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

  9. Oct 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  10. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  11. Jul 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  12. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  13. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  14. Feb 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  15. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE3

  16. Nov 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  17. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  18. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  19. Jul 2018 — Sep 2018 [monthly]

    Not Yet Recruiting PHASE3

  20. Jun 2018 — Jul 2018 [monthly]

    Not Yet Recruiting PHASE3

  21. Apr 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE3

  22. Mar 2018 — Apr 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Gene Therapies
Data source: Novartis

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

Study Locations