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Exon Skipping Agent

Vesleteplirsen for Duchenne Muscular Dystrophy (MOMENTUM Trial)

Phase 2
Waitlist Available
Research Sponsored by Sarepta Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Has received prior Vesleteplirsen treatment in Part A of this study or in Study 5051-102.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part b: baseline up to week 304
Awards & highlights

MOMENTUM Trial Summary

This trial will have 2 parts: 1) determining how much of the drug can be given safely, and 2) testing how well the drug works. People who participate in the first part may continue on to the second part.

Who is the study for?
This trial is for individuals with Duchenne Muscular Dystrophy who can potentially benefit from exon 51-skipping treatment. Participants must have previously received SRP-5051 in Part A of this study or in Study 5051-102 to be eligible.Check my eligibility
What is being tested?
The study tests Vesleteplirsen (SRP-5051) in two parts: first, finding the highest dose patients can tolerate without severe side effects (Part A), and then checking how well different doses work (Part B).See study design
What are the potential side effects?
While specific side effects are not listed, typically such trials monitor for reactions at injection sites, potential kidney or liver issues, blood changes, muscle pain, and general discomfort.

MOMENTUM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

MOMENTUM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part b: baseline up to week 304
This trial's timeline: 3 weeks for screening, Varies for treatment, and part b: baseline up to week 304 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence of Adverse Events (AEs)
Part B: Change From Baseline in Dystrophin Protein Level at Week 28
Secondary outcome measures
Part A: PK: Urine Concentration of Vesleteplirsen
Part A: Pharmacokinetics (PK): Plasma Concentration of Vesleteplirsen
Part B: Change From Baseline in Exon-Skipping Levels at Week 28
+4 more

MOMENTUM Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: VesleteplirsenExperimental Treatment1 Intervention
Participants will receive vesleteplirsen at the doses selected based on data from Part A every 4 weeks, via IV infusion, for up to 5 years. This includes the participants who rollover from Part A, as well as the additional participants who will be enrolled at the beginning of Part B.
Group II: Part A: VesleteplirsenExperimental Treatment1 Intervention
Participants received escalating dose levels of vesleteplirsen, every 4 weeks, via intravenous (IV) infusion for up to 75 weeks during Part A. Once the doses have been selected for Part B, all participants who have completed Part A will transition to Part B.

Find a Location

Who is running the clinical trial?

Sarepta Therapeutics, Inc.Lead Sponsor
49 Previous Clinical Trials
33,477 Total Patients Enrolled
Medical DirectorStudy DirectorSarepta Therapeutics, Inc.
2,789 Previous Clinical Trials
8,067,268 Total Patients Enrolled

Media Library

SRP-5051 (Exon Skipping Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04004065 — Phase 2
Duchenne Muscular Dystrophy Research Study Groups: Part B: Vesleteplirsen, Part A: Vesleteplirsen
Duchenne Muscular Dystrophy Clinical Trial 2023: SRP-5051 Highlights & Side Effects. Trial Name: NCT04004065 — Phase 2
SRP-5051 (Exon Skipping Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04004065 — Phase 2
~10 spots leftby Jun 2025
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