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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). 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.
Primary Outcome
* Antiepileptic Drug (AED) levels in blood * Comprehensive panel (blood test) * Complete Blood Count with differential (blood test) * Visual field tests testing * Ophthalmology exam assessment * Frequency and severity of adverse events reported by subjects throughout their involvement with the study
Interventions
- DRUG vigabatrin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
Why NCT01266291 stopped before completion
NCT01266291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which vigabatrin is the first listed.
NCT01266291 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01266291's enrollment target sits among peer trials
1 2000th of 2000 the lowest of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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