Brivaracetam Efficacy for Treating Acute Seizures in Epilepsy Monitoring Unit

Wednesday, December 05, 2018

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) and 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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