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NCT04004065CompletedPhase 2

Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Efficacy (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment (MOMENTUM)

A Phase 2, Two-Part, Multiple-Ascending-Dose Study of SRP-5051 for Dose Determination, then Dose Expansion, in Patients with Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment

Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Oct 2024

Brief summary (registry, in English)

Part A: To evaluate the safety and tolerability of multiple ascending doses of SRP-5051, administered intravenously (IV) every 4 weeks, and determine the maximum tolerated dose (MTD) Part B: To evaluate dystrophin protein level in skeletal muscle tissue following SRP-5051 treatment, administered IV every 4 weeks at the doses selected based on data from Part A

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
21 (actual)
First submitted
28 Mar 2024
Start date
21 Aug 2020
Lead sponsor
Sarepta Therapeutics Inc.
NCT number
NCT04004065
EU CT number
2023-509935-23-00
EudraCT number
2019-000601-77

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 21
  • 8 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Age in the registry: - to 64 years · Sex: Male · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Sant Joan De Deu Barcelona Hospital
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Esplugues De LlobregatSpainCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsCompleted

This page is information, not medical advice. Discuss any trial with your doctor.