deltatrials
Recruiting PHASE2/PHASE3 INTERVENTIONAL 1-arm NCT03373968

Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

Open Label, Long-term Safety, Tolerability, and Efficacy Study of GIVINOSTAT in All DMD Patients Who Have Been Previously Treated in One of the GIVINOSTAT Studies

Sponsor: Cromsource

Conditions Duchenne Muscular Dystrophy
Interventions Givinostat
Updated 22 times since 2017 Last updated: Jan 19, 2026 Started: Oct 24, 2017 Primary completion: Dec 31, 2029 Completion: Dec 31, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2/PHASE3 trial investigates Duchenne Muscular Dystrophy and is currently actively recruiting participants. Cromsource leads this study, which shows 22 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Mar 2020 · 6 months · monthly snapshot~Mar 2020 – ~Jun 2020 · 3 months · monthly snapshot~Jun 2020 – ~Oct 2020 · 4 months · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Feb 2022 · 5 months · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~Dec 2023 · 20 months · monthly snapshot~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshot~Feb 2026 – present · 6 months · monthly snapshot

Change History

22 versions recorded

  1. Feb 2026 — Present [monthly]

    Recruiting PHASE2/PHASE3

    Status: Active Not Recruiting → Recruiting

  2. Sep 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE2/PHASE3

  3. May 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE2/PHASE3

    Status: Enrolling By Invitation → Active Not Recruiting

  4. Sep 2024 — May 2025 [monthly]

    Enrolling By Invitation PHASE2/PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Enrolling By Invitation PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

▶ Show 17 earlier versions

  1. Dec 2023 — Jul 2024 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  2. Apr 2022 — Dec 2023 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  3. Feb 2022 — Apr 2022 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  4. Sep 2021 — Feb 2022 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  5. May 2021 — Sep 2021 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  6. Jan 2021 — May 2021 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  7. Dec 2020 — Jan 2021 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  8. Oct 2020 — Dec 2020 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

    Status: Recruiting → Enrolling By Invitation

  9. Jun 2020 — Oct 2020 [monthly]

    Recruiting PHASE2_PHASE3

  10. Mar 2020 — Jun 2020 [monthly]

    Recruiting PHASE2_PHASE3

  11. Sep 2019 — Mar 2020 [monthly]

    Recruiting PHASE2_PHASE3

  12. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE2_PHASE3

  13. May 2019 — Aug 2019 [monthly]

    Recruiting PHASE2_PHASE3

  14. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE2_PHASE3

  15. Jun 2018 — Apr 2019 [monthly]

    Recruiting PHASE2_PHASE3

  16. Jan 2018 — Jun 2018 [monthly]

    Recruiting PHASE2_PHASE3

  17. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE2_PHASE3

    First recorded

Oct 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cromsource
  • Italfarmaco
Data source: Italfarmaco

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

Study Locations

Atlanta, United States , Barcelona, Spain , Belgrade, Serbia , Calgary, Canada , Esplugues de Llobregat, Spain , Essen, Germany , Gainesville, United States , Genova, Italy , Gobowen, United Kingdom , Hamburg, Germany and 26 more locations