Psychiatric adverse events in three phase III trials of eslicarbazepine acetate for focal seizures.
Hamada H AltalibTodd GrinnellDavid CantuFábio IkedoMariana VieiraYi ZhangDavid BlumPublished in: Epilepsia open (2022)
Overall, in clinical trials of ESL in adults with focal seizures, incidences of psychiatric events were not statistically different between patients taking ESL and placebo, were not related to ESL dose, and generally occurred more frequently in patients with baseline psychiatric symptoms or a history of psychiatric disorders. Long-term exposure to ESL was not associated with a marked increase in the incidence of psychiatric TEAEs.
Keyphrases
- phase iii
- clinical trial
- mental health
- open label
- end stage renal disease
- ejection fraction
- newly diagnosed
- double blind
- phase ii
- chronic kidney disease
- risk factors
- peritoneal dialysis
- placebo controlled
- prognostic factors
- randomized controlled trial
- physical activity
- patient reported outcomes
- patient reported
- study protocol