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.
- Diseases
- Duchenne muscular dystrophy
- 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
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Completed |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.