Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures

Phase 2 Completed 123 enrolled Bial - Portela C S.A.

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.

Timeline

Start: 2010-08
Primary completion: 2012-03
Completion: 2013-05

Outcome

Missed primary endpoint

registry Mean Difference (Final Values) 33.2001 (95% CI -137.593 to 203.993) NCT01527513 ↗

Publications

Mintz M, Pina-Garza JE, Wolf SM, McGoldrick PE, Jozwiak S, Grinnell T, Cantu D, Costa R, Moreira J, Li Y, Blum D. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures. J Child Neurol. 2020 Mar;35(4):265-273. doi: 10.1177/0883073819890997. Epub 2019 Dec 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eslicarbazepine acetate	Unknown	30 mg/kg	Oral