At the American Epilepsy Society Annual Meeting in New Orleans, LA, data were presented from an open-label, randomized, parallel-group, active control study (NCT03021018) showed brivaracetam (BRV) (Briviact; UCB, Atlanta, GA) and lorazepam (LZP) had similar efficacy for treatment of patients with acute seizures in an epilepsy monitoring unit.
In this phase 2 proof-of-concept study, 45 patients were randomly assigned to equal groups of 15 patients to receive LZP at the investigator’s usual dose in a single intravenous (IV) bolus, 100 mg BRV IV over 2 minutes, or 200 mg BRV IV over 4 minutes. Of those treated with LZP, 5 had a seizure within 12 hours; for those treated with 100 mg or 200 mg of BRV, 3 patients in each group had a seizure within 12 hours. Although this was too small a study to determine significance, Kaplan-Meier analysis suggests this reflects similar efficacy of all 3 treatments. More patients in the LZP group needed rescue medications than in either BRV group.
The most common treatment-emergent adverse events were dizziness (20.0% BRV 100 mg, 6.7% BRV 200 mg, 0% LZP), nausea (13.3% each for BRV groups, 0% LZP), headache (13.3% BRV 100 mg, 6.3% LZP, 0% BRV 200 mg), sedation (12.5% LZP, 6.7% BRV 200 mg, 0% BRV 100 mg), and somnolence (12.5% LZP, 0% for both BRV doses).
Several other observational studies of small cohorts and post-hoc analysis of data from open-label extensions showed response rates similar to that seen in pivotal trials, including studies in adults and children with medically refractory epilepsy. Post hoc analysis of open-label trial extensions showed that during the extension periods 42% of adults (n = 503) and 54% of children (n = 219) continued taking BRV with the most common reasons for discontinuation being lack of efficacy and adverse events.
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