deltatrials
Completed PHASE2/PHASE3 NCT03098797

A Trial to Evaluate Safety, Tolerability and Efficacy of Elamipretide in Subjects With Barth Syndrome

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Safety and Efficacy of Subcutaneous Injections of Elamipretide in Subjects With Genetically Confirmed Barth Syndrome Followed by Open-Label Treatment

Sponsor: Stealth BioTherapeutics Inc.

Conditions Barth Syndrome
Interventions Elamipretide Placebo
Updated 15 times since 2017 Last updated: Apr 14, 2024 Started: Jul 5, 2017 Primary completion: Oct 5, 2018 Completion: Oct 11, 2021

A PHASE2/PHASE3 clinical study on Barth Syndrome, this trial is completed. The trial is conducted by Stealth BioTherapeutics Inc. and has accumulated 15 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Change History

15 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  3. May 2024 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  4. Apr 2022 — May 2024 [monthly]

    Completed PHASE2_PHASE3

    Status: Active Not Recruiting → Completed

  5. Dec 2021 — Apr 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

▶ Show 10 earlier versions

  1. Jan 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  2. May 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  3. Feb 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  4. Mar 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  5. Nov 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  6. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  7. Jun 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  8. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Recruiting → Active Not Recruiting

  9. Jun 2017 — Mar 2018 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet Recruiting → Recruiting

  10. May 2017 — Jun 2017 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Stealth BioTherapeutics Inc.
Data source: Stealth BioTherapeutics Inc.

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

Study Locations

  • • Baltimore, United States