Microdystrophin Gene Transfer Study in Adolescents and Children With DMD (NCT03368742) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Microdystrophin Gene Transfer Study in Adolescents and Children With DMD
United States12 participantsStarted 2017-12-06
Plain-language summary
This is a controlled, open-label, single-ascending dose study to evaluate the safety and tolerability of SGT-001 in adolescents and children with Duchenne muscular dystrophy (DMD). Participants will receive a single intravenous (IV) infusion of SGT-001 and will be followed for approximately 5 years.
The protocol was amended to drop the control arm after 4 participants were dosed.
Who can participate
Age range
4 Years – 17 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Established clinical diagnosis of DMD and documented dystrophin gene mutation predictive of DMD phenotype
* Confirmed absence of dystrophin as determined by muscle biopsy (ambulatory participants)
* Anti-AAV9 antibodies below protocol-specified thresholds
* Stable cardiac and pulmonary function
* Adolescents: non-ambulatory by protocol-specified criteria
* Children: ambulatory by protocol-specified criteria
* Stable daily dose (or equivalent) of oral corticosteroids ≥ 12 weeks
Exclusion Criteria:
* Prior or ongoing medical condition or physical examination, ECG or laboratory findings that could adversely affect participant safety, compromise completion of treatment and follow-up, or impair assessment of study results
* Abnormal liver function
* Abnormal renal function
* Clinically significant coagulation abnormalities
* Impaired cardiovascular function based on cardiac MRI or ECHO
* Impaired respiratory function based on FVC % predicted or need for daytime ventilatory support
* Significant spinal deformity or presence of spinal rods
* Body mass index ≥ 95th percentile for age
* Exposure to another investigational drug within 3 months or 5 half-lives prior to screening
* Exposure to drugs affecting dystrophin or utrophin expression within 6 months prior to screening
Additional inclusion/exclusion criteria may apply.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Treatment Emergent Adverse Events (TEAEs)