deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 4-arm NCT02310906

Phase I/II Study of SRP-4053 in DMD Patients

A 2-Part, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration, Safety, Tolerability, and Pharmacokinetics Study (Part 1) Followed by an Open-Label Efficacy and Safety Evaluation (Part 2) of SRP-4053 in Patients With Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping

Sponsor: Catholic University of the Sacred Heart

Conditions Duchenne Muscular Dystrophy
Interventions Placebo SRP-4053
Updated 14 times since 2017 Last updated: Oct 14, 2020 Started: Jan 13, 2015 Primary completion: Mar 25, 2019 Completion: Mar 25, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Duchenne Muscular Dystrophy and is currently completed. Catholic University of the Sacred Heart leads this study, which shows 14 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2018 · 15 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~Jul 2019 · 3 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Nov 2020 · 15 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Apr 2024 · 30 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

14 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  3. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Oct 2021 — Apr 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE1_PHASE2

▶ Show 9 earlier versions

  1. Nov 2020 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  2. Aug 2019 — Nov 2020 [monthly]

    Completed PHASE1_PHASE2

  3. Jul 2019 — Aug 2019 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not Recruiting → Completed

  4. Apr 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Dec 2018 — Apr 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  6. Jun 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  7. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  8. Feb 2017 — May 2018 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  9. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    First recorded

Jan 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Catholic University of the Sacred Heart
  • Consultants for Research in Imaging and Spectroscopy
  • Great Ormond Street Hospital for Children NHS Foundation Trust
  • Institut de Myologie, France
  • Royal Holloway University
  • SYSNAV
  • Sarepta Therapeutics, Inc.
  • University College, London
  • University of Newcastle Upon-Tyne
Data source: Sarepta Therapeutics, Inc.

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

Study Locations