deltatrials
Completed PHASE2 INTERVENTIONAL 6-arm NCT03439670

A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study With Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)

Sponsor: Cooperative International Neuromuscular Research Group

Conditions Duchenne Muscular Dystrophy
Interventions Placebo Prednisone Vamorolone
Updated 29 times since 2018 Last updated: Mar 7, 2023 Started: Jun 29, 2018 Primary completion: Feb 23, 2021 Completion: Aug 19, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03439670, this PHASE2 trial focuses on Duchenne Muscular Dystrophy and remains completed. Sponsored by Cooperative International Neuromuscular Research Group, it has been updated 29 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Dec 2018 · 4 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 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 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Mar 2020 · 2 months · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~Aug 2020 · 4 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Sep 2022 · 11 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Mar 2023 · 59 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 11 months · monthly snapshot

Change History

29 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. Apr 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Mar 2023 — Apr 2023 [monthly]

    Completed PHASE2

▶ Show 24 earlier versions

  1. Jan 2023 — Mar 2023 [monthly]

    Completed PHASE2

  2. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

  3. Sep 2022 — Dec 2022 [monthly]

    Completed PHASE2

  4. Oct 2021 — Sep 2022 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  5. Jan 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE2

  6. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  7. Aug 2020 — Oct 2020 [monthly]

    Recruiting PHASE2

  8. Apr 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

  9. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE2

  10. Jan 2020 — Mar 2020 [monthly]

    Recruiting PHASE2

  11. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE2

  12. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE2

  13. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE2

  14. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE2

  15. Jul 2019 — Sep 2019 [monthly]

    Recruiting PHASE2

  16. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE2

  17. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE2

  18. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE2

  19. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE2

  20. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE2

  21. Aug 2018 — Dec 2018 [monthly]

    Recruiting PHASE2

  22. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  23. Jun 2018 — Jul 2018 [monthly]

    Not Yet Recruiting PHASE2

  24. Mar 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cooperative International Neuromuscular Research Group
  • European Union
  • Newcastle University
  • ReveraGen BioPharma, Inc.
  • University of Pittsburgh
Data source: ReveraGen BioPharma, Inc.

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

Study Locations

Athens, Greece , Aurora, United States , Barcelona, Spain , Birmingham, United Kingdom , Brno, Czechia , Calgary, Canada , Chicago, United States , Dallas, United States , Davis, United States , Durham, United States and 23 more locations