Long-term safety, efficacy, and quality of life outcomes with adjunctive brivaracetam treatment at individualized doses in patients with epilepsy: An up to 11-year, open-label, follow-up trial.

ABSTRACT:

Objective

To evaluate long-term safety/tolerability of brivaracetam at individualized doses ≤200 mg/d (primary) and maintenance of efficacy over time (secondary) in adults with focal seizures or primary generalized seizures (PGS) enrolled in phase 3, open-label, long-term follow-up trial N01199 (NCT00150800).

Methods

Patients ≥16 years of age who had completed double-blind, placebo-controlled adjunctive brivaracetam trials NCT00175825, NCT00490035, NCT00464269, or NCT00504881 were eligible. Outcomes included safety, efficacy, and quality of life.

Results

The safety set included 667 patients (focal seizures, 97.8%; PGS, 2.2%); the efficacy set included 648 patients with focal seizures and 15 patients with PGS. Overall, 49.2% of patients had ≥48 months of exposure. Trea

SUBMITTER: O'Brien TJ 

PROVIDER: S-EPMC7384045 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature