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NCT03375164 · ClinicalTrials.gov registry record · Phase 1

A Gene Transfer Therapy Study to Evaluate the Safety of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)

A Phase 1 study of Duchenne Muscular Dystrophy, sponsored by Sarepta Therapeutics.

Completed
Registry status
Phase 1
Development phase
4
Enrollment target
1
Study location

NCT03375164 is a Phase 1 study of Duchenne Muscular Dystrophy that has completed, run by Sarepta Therapeutics. The registered enrollment target is 4 participants, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03375164, a Phase 1 study of Duchenne Muscular Dystrophy, has completed, sponsored by Sarepta Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
4 participants
Enrollment target
1
Study location

Study Summary

This study was an open-label single-dose gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec intravenous (IV) administration in boys with DMD. This study was originally designed to consist of 12 patients across 2 Cohorts. Cohort A would have included participants ages 3 months to 3 years, and Cohort B included participants ages 4 to 7 years old. No participants were enrolled in Cohort A.

Interventions

  • GENETIC delandistrogene moxeparvovec

Study Locations (1)

Ohio

  • Nationwide Children's Hospital - Columbus

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2018-01-04
Est. Completion 2023-04-25
Phase Phase 1

Sponsor

Sarepta Therapeutics

33 total trials

What the Registry Record Tells You About NCT03375164

The ClinicalTrials.gov registry entry for NCT03375164 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 412-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (99% lower). The listed sponsor is Sarepta Therapeutics, which has 33 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which delandistrogene moxeparvovec is the first listed.

NCT03375164 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT03375164 about?

NCT03375164 is a clinical study titled "A Gene Transfer Therapy Study to Evaluate the Safety of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)". This study was an open-label single-dose gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec intravenous (IV) administration in boys with DMD. This study was originally designed to consist of 12 patients across 2 Cohorts. Cohort A would have included participants ages 3...

What is the current status of trial NCT03375164?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2018-01-04. Estimated completion is 2023-04-25.

What conditions does trial NCT03375164 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.

What interventions are being tested in trial NCT03375164?

The interventions under investigation include: delandistrogene moxeparvovec (GENETIC).

Who is sponsoring clinical trial NCT03375164?

This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03375164 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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