A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)

Inclusion Criteria

• •1. The patient speaks English or Spanish.
• •2. The patient has had no prior exposure to Sabril.
• •3. To begin Sabril therapy for the treatment of CPS.
• •4. Male or female ≥18 years of age.
• •5. The patient has refractory CPS:
• •1. The patient has complex partial epilepsy of more than 1 year duration and no other seizure type within the past year except for partial seizures secondarily generalized.
• •2. The patient has failed because of lack of efficacy 3 or more prior or concurrent treatment trials including 3 or more anti-epileptic drugs (AEDs) of differing pharmacologic mechanisms administered as monotherapy or polytherapy.
• •3. The patient is taking at least 1 AED. A vagal nerve stimulator is not counted as an AED.
• •4. The patient reports an average of 2 or more seizures per month averaged over the prior 3 months.
• •6. The patient is deemed by the treating neurologist and ophthalmologist to be able to reliably complete perimetry testing.
• •7. The initial (Visit 1) SD-OCT and static perimetry readings tests must be performed and assessed for technical adequacy by the SD-OCT and perimetry central readers prior to the first dose of Sabril. The initial (Visit 1) tangent corner test must be performed prior to the first dose of Sabril.