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NCT00033813 · ClinicalTrials.gov registry record · Phase 2
KUL0401: An Open-label Pilot Study of Oxatomide in Steroid-Naive Duchenne Muscular Dystrophy
A Phase 2 study, sponsored by Cooperative International Neuromuscular Research Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00033813: Completed Phase 2 study, sponsored by Cooperative International Neuromuscular Research Group.
NCT00033813 is a Phase 2 study that has completed, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00033813, a Phase 2 study, has completed, sponsored by Cooperative International Neuromuscular Research Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DRUG Oxatomide (tinset)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2002-01 |
| Phase | Phase 2 |
What the finished NCT00033813 record still lists
NCT00033813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Oxatomide (tinset) is the first listed.
NCT00033813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00033813 about?
NCT00033813 is a clinical study titled "KUL0401: An Open-label Pilot Study of Oxatomide in Steroid-Naive Duchenne Muscular Dystrophy". 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 an...
What is the current status of trial NCT00033813?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2002-01.
What interventions are being tested in trial NCT00033813?
The interventions under investigation include: Oxatomide (tinset) (DRUG).
Who is sponsoring clinical trial NCT00033813?
This trial is sponsored by Cooperative International Neuromuscular Research Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00033813's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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