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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 up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 1 & 2 trial • 4 Patients • NCT03375164
100%
Upper respiratory tract infection
100%
Vomiting
75%
Hepatic enzyme increased
50%
COVID-19
50%
Gastrooesophageal reflux disease
50%
Procedural pain
50%
Decreased appetite
50%
Fatigue
50%
Cough
25%
Pyrexia
25%
Abdominal discomfort
25%
Abdominal distension
25%
Abdominal pain upper
25%
Gastroenteritis
25%
Headache
25%
Dermatitis contact
25%
Anal incontinence
25%
Diarrhoea
25%
Nausea
25%
Eye irritation
25%
Proteinuria
25%
Gastroenteritis viral
25%
Subcutaneous abscess
25%
Viral infection
25%
Asthenia
25%
Clavicle fracture
25%
Cardiomyopathy
25%
Skin papilloma
25%
Influenza A virus test positive
25%
Back pain
25%
Bone pain
25%
Pain in extremity
25%
Asthma
25%
Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Delandistrogene Moxeparvovec

Awards & Highlights

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.

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

Find a Location

Who is running the clinical trial?

Sarepta Therapeutics, Inc.Lead Sponsor
52 Previous Clinical Trials
33,568 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,456 Previous Clinical Trials
1,097,212 Total Patients Enrolled

Media Library

Delandistrogene Moxeparvovec Clinical Trial Eligibility Overview. Trial Name: NCT05967351 — Phase 3
Duchenne Muscular Dystrophy Research Study Groups: Delandistrogene Moxeparvovec
Duchenne Muscular Dystrophy Clinical Trial 2023: Delandistrogene Moxeparvovec Highlights & Side Effects. Trial Name: NCT05967351 — Phase 3
Delandistrogene Moxeparvovec 2023 Treatment Timeline for Medical Study. Trial Name: NCT05967351 — Phase 3
~267 spots leftby Nov 2030
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