Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients (STARS)
Complex Partial Seizures
About this trial
This is an interventional treatment trial for Complex Partial Seizures focused on measuring Tuberous sclerosis, TS, Seizures
Eligibility Criteria
Inclusion Criteria:
- The patient or patient's legally authorized representative must sign and date the Institutional Review Board approved Informed Consent and HIPPA Authorization Form.
- Male and female patients 18+ years of age with a clinical diagnosis of Tuberous Sclerosis who experience an average of at least three partial seizures every two months, of which one must be a complex partial seizure
- Patient must be on at least one and a maximum of four AEDs. Patient must be on a stable AED dose regimen for at least 30 days prior to screening. Neither a Vagal Nerve Stimulator (VNS) nor the ketogenic diet will count as an AED
- In the investigator's opinion, the patient or caregiver must be able to keep a seizure diary
- An MRI in the last 5 years, or willingness to undergo an MRI as part of the screening process
Exclusion Criteria:
- Cause of patient's seizures is a neurologic disease that is not Tuberous Sclerosis
- Current, clinical diagnosis of a major depressive episode or suicidal ideation
- Patient is taking more than four concurrent AEDs. Note: VNS or ketogenic diet is allowed and will not be counted in the four allowed AEDs
- Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan
- Patient is currently abusing drugs or alcohol
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Other
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.