Sarepta Therapeutics has shared an update that SRP-5051-201, the MOMENTUM study (NCT04004065), is now recruiting Part B.
MOMENTUM is a Phase 2, two-part, multiple-ascending-dose study of SRP-5051 for dose determination, then dose expansion, in patients with Duchenne muscular dystrophy amenable to exon 51-skipping treatment.
Part B of MOMENTUM will enroll males with Duchenne who are 7-21 years old. There are two cohorts in Part B of this study: one cohort for participants who were previously treated with SRP-5051 (participants from Part A of MOMENTUM or the 5051-102 study), and one cohort for participants who have never been treated with SRP-5051.
Read more in Sarepta’s Community Bulletin below.
Community Bulletin: MOMENTUM, Study SRP-5051-201, Update
Clinicaltrials.gov has been updated to reflect that SRP-5051-201, the MOMENTUM study (NCT04004065), is now recruiting Part B. MOMENTUM is a Phase 2, two-part, multiple-ascending-dose study of SRP-5051 for dose determination, then dose expansion, in patients with Duchenne Muscular Dystrophy amenable to exon 51-skipping treatment.
Part B of MOMENTUM will enroll males with Duchenne who are 7-21 years old. Each study participant will receive SRP-5051 every 4 weeks via IV infusion for up to 2 years. There are two cohorts in Part B of this study: one cohort for participants who were previously treated with SRP-5051 (participants from Part A of MOMENTUM or the 5051-102 study), and one cohort for participants who have never been treated with SRP-5051.
More information about the MOMENTUM study may be found on clinicaltrials.gov (NCT04004065). Please always consult with your doctor about your interests in joining clinical trials.
Study site activation times will vary as part B gets underway, and newly activated sites will be added to clinicaltrials.gov when they are open for recruitment. If you have questions about participation in MOMENTUM, you may reach out to a trial site near you or you may email advocacy@sarepta.com.
Due to the uncertainties related to the pandemic, and our hope for uninterrupted participation and monitoring of participants, international relocation will not be supported for this trial. Ultimately, site investigators select and qualify participants for trials, and we are recommending against cross-border participation or participation outside one’s home country.