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NCT01803412 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety, Tolerability & Efficacy of Long-term Administration of Drisapersen in US & Canadian Subjects
A Phase 3 study, sponsored by BioMarin Pharmaceutical.
- Terminated
- Registry status
- Phase 3
- Development phase
- 53
- Enrollment target
NCT01803412 is a Phase 3 study that was terminated before completion, run by BioMarin Pharmaceutical. The registered enrollment target is 53 participants.
The verdict
NCT01803412, a Phase 3 study, was terminated before completion, sponsored by BioMarin Pharmaceutical.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 53 participants
- Enrollment target
Study Summary
This is a phase III, multicenter, open-label, uncontrolled extension study in male subjects with DMD open to eligible US and Canadian subjects who previously participated in the following studies of drisapersen: DMD114876, DMD114044 and DMD114349. Subjects will receive 6mg/kg subcutaneous drisapersen on a weekly basis. For subjects who have previously experienced significant safety or tolerability issues or who experience these during the study, there is the potential of an alternate intermittent dosing arm that will be given as a regimen of 6 mg/kg weekly for 8 weeks followed by 4 weeks off treatment. For subjects who experience or have previously experienced significant safety/tolerability issues, side effects or reactions or intermittent dosing, intravenous dosing will be made available.
Interventions
- DRUG Drisapersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2013-05-01 |
| Est. Completion | 2016-10-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01803412
The ClinicalTrials.gov registry entry for NCT01803412 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Drisapersen is the first listed.
NCT01803412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01803412 about?
NCT01803412 is a clinical study titled "A Study of the Safety, Tolerability & Efficacy of Long-term Administration of Drisapersen in US & Canadian Subjects". This is a phase III, multicenter, open-label, uncontrolled extension study in male subjects with DMD open to eligible US and Canadian subjects who previously participated in the following studies of drisapersen: DMD114876, DMD114044 and DMD114349. Subjects will receive 6mg/kg subcutaneous drisaperse...
What is the current status of trial NCT01803412?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2013-05-01. Estimated completion is 2016-10-01.
What interventions are being tested in trial NCT01803412?
The interventions under investigation include: Drisapersen (DRUG).
Who is sponsoring clinical trial NCT01803412?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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