Cenobamate (Mixed indications = All indications)

Study Type of data Exposure measurement Outcome assessment Adjustment
The NAAED (Indications NOS) (Controls exposed to LTG), 2024 prospective cohort Women are interviewed at enrollment, at 7 months’ gestation and at 8 –12 weeks after the expected date of delivery. The computer-assisted interviews include questions on start and stop dates of each antiepileptic drugs taken, dose, frequency and changes in medication. Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist. No adjustment for this group of exposure and comparison.
The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 prospective cohort Women are interviewed at enrollment, at 7 months’ gestation and at 8 –12 weeks after the expected date of delivery. The computer-assisted interviews include questions on start and stop dates of each antiepileptic drugs taken, dose, frequency and changes in medication. Women were questioned with a computer-assisted telephone interview 3 times and medical records were obtained. The written descriptions in the pediatricians’ examinations were reviewed separately by the clinical teratologist. No adjustment for this group of exposure and comparison.

master protocol