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NCT01266291 · ClinicalTrials.gov registry record · Phase 4
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
A Phase 4 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT01266291: Clinical Trial Phase 4 study, sponsored by University of Pennsylvania.
NCT01266291 is a Phase 4 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01266291, a Phase 4 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial epilepsy population for which the drug is approved. While enrolled on this trial, subjects will continue to take all of their normally prescribed medications, including their other antiepileptic drugs (AEDs). Alternatively, there is a prospective observational arm that subjects who are about to take Sabril as treatment for seizures associated with Tuberous Sclerosis may join. Subjects who join this arm will not have any study visits and will not be asked to do anything specifically for the study. The study team will collect all study data from subjects' medical records only.
Interventions
- DRUG vigabatrin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01266291
The ClinicalTrials.gov registry entry for NCT01266291 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which vigabatrin is the first listed.
NCT01266291 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01266291 about?
NCT01266291 is a clinical study titled "Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients". This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial epilepsy population for which the drug is approved. While enrolled on this trial, subjects will continue to take all of the...
What is the current status of trial NCT01266291?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2010-08. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01266291?
The interventions under investigation include: vigabatrin (DRUG).
Who is sponsoring clinical trial NCT01266291?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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