Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients
Condition: Complex Partial Seizures
MeSH terms: Tuberous Sclerosis; Seizures
Intervention: vigabatrin
Intervention description: 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.
Intervention MeSH terms: Vigabatrin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tuberous sclerosis; TS; Seizures

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.
    

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