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Long-term Follow-up for Delandistrogene Moxeparvovec in Duchenne Muscular Dystrophy (EXPEDITION Trial)
Phase 3
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 years
Awards & highlights
EXPEDITION Trial Summary
This trial looks at long-term safety/efficacy of a drug given in a past study, w/o administering the drug again. Participants will be monitored for 5+ years post-infusion.
Who is the study for?
This study is for individuals with Duchenne muscular dystrophy who previously received delandistrogene moxeparvovec. Participants must either have a parent or caregiver, or be adults who understand and can follow the study's schedule and requirements.Check my eligibility
What is being tested?
The trial monitors long-term safety and effectiveness of delandistrogene moxeparvovec in participants from an earlier study. No new drug will be given; it tracks health for at least 5 years after the initial treatment.See study design
What are the potential side effects?
Since no new drug is administered in this follow-up study, side effects are not a primary concern here. It focuses on observing any long-term effects from the previous administration of delandistrogene moxeparvovec.
EXPEDITION Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with a Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)
Secondary outcome measures
Change in Cardiac Magnetic Resonance Imaging (MRI) Findings From Pre-infusion Baseline to 5 Years Post-infusion of Delandistrogene Moxeparvovec
Change in Forced Vital Capacity Percent (FVC%) Predicted From Pre-infusion Baseline to 5 Years Post-infusion of Delandistrogene Moxeparvovec
Change in Musculoskeletal MRI Findings From Pre-infusion Baseline to 5 Years Post-infusion of Delandistrogene Moxeparvovec
+6 moreEXPEDITION Trial Design
1Treatment groups
Experimental Treatment
Group I: Delandistrogene MoxeparvovecExperimental Treatment1 Intervention
Participant received delandistrogene moxeparvovec in a previous clinical study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
delandistrogene moxeparvovec
2018
Completed Phase 2
~50
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Who is running the clinical trial?
Sarepta Therapeutics, Inc.Lead Sponsor
49 Previous Clinical Trials
33,139 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,430 Previous Clinical Trials
1,089,022 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received delandistrogene moxeparvovec for Duchenne muscular dystrophy in a past study.I am over 18 or have a caregiver and can follow the study plan.I prefer not to share my trial participation with my doctor or other healthcare providers.
Research Study Groups:
This trial has the following groups:- Group 1: Delandistrogene Moxeparvovec
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers still taking on participants for this experiment?
"Unfortunately, this clinical trial is not currently accepting new patients. This particular study was initially posted on August 31st 2023 and last updated July 21st; however, there are 89 other trials with open enrolment at the moment."
Answered by AI
How secure is Delandistrogene Moxeparvovec in terms of potential adverse effects?
"The safety of Delandistrogene Moxeparvovec has been evaluated as 3 due to the completion of Phase III trials, which have yielded promising efficacy data and multiple sets of supportive evidence regarding its security."
Answered by AI
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