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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
65
Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
California Pacific Medical Center
San Francisco, California, United States
Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)
Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field.
Time frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)
Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease.
Time frame: Baseline (Month 0), Month 3, Month 6, Month 9, Month 12
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