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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ part b: baseline up to week 304

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.

0 / 1Eligibility criteria met

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.

2,777 Previous Clinical Trials

8,063,418 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this clinical trial be beneficial for patients over the age of 50?

"This study is looking for participants who are aged 7 to 21 years old."

Answered by AI

Are there any prerequisites to joining this clinical trial?

"Eligibility criteria for this specific clinical trial requires that patients have a diagnosis of muscular dystrophy and are between the ages of 7-21. Currently, the study is looking to recruit 60 participants."

Answered by AI

What is the official government stance on SRP-5051?

"While there is some data indicating that SRP-5051 is safe, its efficacy has not been clinically proven yet. Therefore, it received a score of 2."

Answered by AI

Can new patients still sign up for this clinical trial?

"The trial is recruiting participants, according to the latest update on clinicaltrials.gov from 11/4/2022. The posting date for the trial was 6/26/2019."

Answered by AI

How many people will be included in this investigation?

"This trial needs 60 individuals that meet the pre-screening requirements in order to commence. Would-be participants can reside near various sites, such as UPMC Children's Hospital of Pittsburgh or University of Iowa Hospitals and Clinics."

Answered by AI