Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients (STARS)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Sabril for Treatment of Adult Refractory Partial Seizures Symptomatic of Tuberous Sclerosis: An Open Label, Phase IV Prospective Safety and Tolerability Study|
- Number of Participants Safely Tolerating Sabril [ Time Frame: Outcome measures will be assessed at the initiation of Sabril (titration), and at three and five months after starting Sabril. After this time, the subjects will have completed the study. ]
- 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
- Number of Patients Who Become Seizure Free While Taking Sabril [ Time Frame: Seizure freedom will be assessed for the two month treatment phase of the study (months 4 and 5) ]
- Seizure freedom
- Responder rate (complex partial seizures only)
|Study Start Date:||August 2010|
|Study Completion Date:||December 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Treatment with Sabril (vigabatrin)
This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
Subjects will begin taking vigabatrin (Sabril) during the third month of the study. Upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
Other Name: Sabril
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266291
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||John Pollard, MD||University of Pennsylvania|