Felbamate (Epilepsy = All indications)

Study Type of data Exposure measurement Outcome assessment Adjustment
Battino (Felbamate) (Epilepsy), 2024 prospective cohort Reporting physicians collected information on drug therapy after each trimester. Abnormalities in the offspring were recorded descriptively by reporting physicians. A committee blinded to type of exposure assessed and categorized these abnormalities. When necessary, the committee solicited additional information from the reporting physicians. Exclusion of pregnancies exposed to known teratogenic drugs, and those with comorbidities associated with teratogenic risks. No adjustment for this group of comparison.
Katz (Felbamate), 2001 retrospective cohort Telephone interviews were given to the patient as a supplement to the chart analysis. Spouses were interviewed only when additional information could not be provided by the patient. Data collected in chart review about the newborn included the presence of developmental delay. Including pervasive developmental delay (based on the DSM-IV-TR criteria), combined or isolated speech and gross motor delay and attention deficit disorder with speech and auditory processing delay. None.

master protocol