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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 is a Phase 2 study that has completed, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 15 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00033813
The ClinicalTrials.gov registry entry for NCT00033813 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cooperative International Neuromuscular Research Group, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxatomide (tinset) is the first listed.
NCT00033813 reports 0 study locations.
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.
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