The vigabatrin patient registry was implemented in August 2009 in conjunction with Food and Drug Administration approval of vigabatrin. All US vigabatrin-treated patients must enroll in the registry. Data on prescriber specialty/location, patient demographics, and clinical characteristics are collected. Benefit-risk assessments are required early in the course of therapy. Vision assessments are required at baseline (≤ 4. weeks after therapy initiation), every 3. months during therapy, and 3 to 6. months after discontinuation. As of February 1, 2011, 2473 patients (1500 with infantile spasms, 846 with refractory complex partial seizures, 120 with other diagnoses) had enrolled; 30.4% were previously exposed to vigabatrin. Kaplan-Meier analysis of time in registry indicated that 83 and 97% of all enrolled patients with refractory complex partial seizures and infantile spasms remained beyond 3 and 1. month, respectively. The ongoing registry will provide visual status and other information on vigabatrin-treated patients for both the infantile spasm and refractory complex partial seizure indications.
- Peripheral visual field defect
- Risk evaluation and mitigation strategy
ASJC Scopus subject areas
- Clinical Neurology
- Behavioral Neuroscience