Some epilepsy patients are described as GB when they have worsened seizures or side effects
related to switching between brand name and generic, or between generic antiepileptic drug
(AED) products. In concert with Aim 1 (protocol BEEP2a), this study will uncover possible
reasons for patient problems with the drug switching. Factors that will be studied in GB
epilepsy patients include physiologic, psychological, and genetic factors, including in this
protocol whether brand and generic AEDs are pharmacokinetically similar in GB individuals.
Phase:
Phase 1
Details
Lead Sponsor:
Food and Drug Administration (FDA)
Collaborators:
University of Maryland University of Maryland, Baltimore