Adult Refractory Complex Partial Seizures Clinical Trial
Official title:
A Prospective, Open-label Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)
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®)
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
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care