deltatrials
Terminated PHASE3 INTERVENTIONAL 1-arm NCT03603288

Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E) (SIDEROS-E)

A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study

Sponsor: Santhera Pharmaceuticals

Updated 16 times since 2018 Last updated: Nov 24, 2021 Started: Jul 4, 2018 Primary completion: Nov 25, 2020 Completion: Nov 25, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Interim analysis concluded to futility of main study SIDEROS (SNT-III-012)

This PHASE3 trial investigates Duchenne Muscular Dystrophy and is currently terminated or withdrawn. Santhera Pharmaceuticals leads this study, which shows 16 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Nov 2019 · 6 months · monthly snapshot~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Jan 2022 · 7 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

16 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Apr 2022 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Jan 2022 — Apr 2022 [monthly]

    Terminated PHASE3

Show 11 earlier versions
  1. Jun 2021 — Jan 2022 [monthly]

    Terminated PHASE3

    Status: RecruitingTerminated

  2. Jan 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  3. Nov 2019 — Jan 2021 [monthly]

    Recruiting PHASE3

  4. May 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  5. Mar 2019 — May 2019 [monthly]

    Recruiting PHASE3

  6. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  7. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  8. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  9. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  10. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  11. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

    First recorded

Jul 2018

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Santhera Pharmaceuticals
Data source: Santhera Pharmaceuticals

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