deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT01910649

A Phase I/II, Open Label, Escalating Dose, Pilot Study to Assess Effect, Safety, Tolerability and PK of Multiple SC Doses of Drisapersen in Patients With Duchenne Muscular Dystrophy and to Assess the Potential for IV Dosing as an Alternative Route of Administration

A Phase I/II, Open Label, Escalating Dose, Pilot Study to Assess the Effect, Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Doses of Drisapersen in Patients With Duchenne Muscular Dystrophy and to Assess the Potential for Intravenous Dosing as an Alternative Route of Administration

Sponsor: BioMarin Pharmaceutical

Interventions Drisapersen
Updated 9 times since 2017 Last updated: Nov 4, 2016 Started: Mar 31, 2008 Primary completion: Sep 30, 2016 Completion: Sep 30, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Regulatory approval was not obtained for drisapersen, hence BioMarin is stopping the development of all exon skipping oligonucleotides in DMD.

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This PHASE2 trial investigates Muscular Dystrophies and is currently terminated or withdrawn. BioMarin Pharmaceutical leads this study, which shows 9 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 23 months · monthly snapshotTerminated

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE2

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE2

Show 4 earlier versions
  1. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE2

  2. May 2018 — Jun 2018 [monthly]

    Terminated PHASE2

  3. Aug 2017 — May 2018 [monthly]

    Terminated PHASE2

  4. Jan 2017 — Aug 2017 [monthly]

    Terminated PHASE2

    First recorded

Mar 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • BioMarin Pharmaceutical
Data source: BioMarin Pharmaceutical

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

Study Locations

No location information available.