Conditions: Adult Refractory Complex Partial Seizures
Keywords: Vigabatrin-associated vision change Adult refractory complex partial seizures CPS Epilepsy Seizures Brain diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Enzyme Inhibitors GABA Agents
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 65
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the change in visual fields by means of automated static perimetry and to evaluate the change in retinal structure by means of spectral domain optical coherence tomography (SD-OCT) in adult patients with refractory complex partial seizures (CPS) being treated with vigabatrin (Sabril®)

Detailed description:
Multicenter, prospective open-label study with approximately 25 sites in the US that specialize in caring for adult patients with refractory CPS

* Sites must have access to Humphrey static perimetry and to Spectralis SD-OCT.
* All vision test results will be sent to the central readers for evaluation.
* Additional study tests:

  * The Columbia Suicide Severity Rating Scale (C-SSRS)
  * The National Eye Institute Visual Field Questionnaire-39 (NEI VFQ-39)
  * A whole blood sample for specific analysis of DNA characteristics
  * An optional whole blood sample for exploratory analysis of DNA characteristics
  * Plasma samples for bioanalytical analysis of vigabatrin and blood samples for taurine biomarker analysis

Arms:
arm 1: None

Interventions: intervention 1: Sabril
Intervention descriptions: intervention 1: Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.

Protocol document: