KUL0401: An Open-label Pilot Study of Oxatomide in Steroid-Naive Duchenne Muscular Dystrophy
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This study will help to determine the safety and efficacy of the mast cell stabilizer
Oxatomide as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are
enrolled in this study will should not have taken steroids to treat DMD for at least twelve
months, and should not have taken any nutritional supplements for at least three months.
Subjects will complete a two screening visits within a one-week period, and if enrolled will
then have their strength tested monthly for three months before beginning therapy with
Oxatomide. Once Oxatomide therapy is started, participants will have their strength tested
monthly for six months. Following the six month treatment period, participants will be given
the option to remain on Oxatomide until the study is completed.
Phase:
Phase 2
Details
Lead Sponsor:
Cooperative International Neuromuscular Research Group