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Abstract Details

Efficacy and Safety of Intravenous Brivaracetam as a Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit
Epilepsy/Clinical Neurophysiology (EEG)
S36 - Epilepsy/Clinical Neurophysiology (EEG) II (2:17 PM-2:28 PM)
008
 Additional treatment options are needed for acute seizures.
Assess efficacy and safety of intravenous (IV) brivaracetam (BRV) vs IV lorazepam (LZP) for acute seizures in patients with epilepsy undergoing evaluation in an Epilepsy Monitoring Unit (EMU).
Phase 2, open-label, randomized, parallel-group, active-controlled proof-of-concept trial (EP0087; NCT03021018). Patients (18-70 years) admitted to EMU were randomized 1:1:1 to single-dose bolus IV LZP (dose per Investigator's practice), IV BRV 100 mg, or IV BRV 200 mg. Administration of trial medication was started by a seizure requiring intervention. Treatment period: from trial medication administration up to 12 hours or until next seizure or until rescue medication administration; safety follow-up: end of treatment period to 24 hours. Primary efficacy outcome: time to next seizure (per clinical observation with electroencephalogram confirmation) or rescue medication; secondary outcomes: time to next seizure (per clinical observation) or rescue medication, seizure freedom and rescue medication use 12 hours after end of trial medication administration; safety outcomes: treatment-emergent adverse events (TEAEs).
11/45 (24.4%) randomized patients who received trial medication for a qualifying seizure had a seizure within 12 hours (LZP=5, BRV 100 mg=3, BRV 200 mg=3), suggesting similar efficacy across treatments, consistent with Kaplan-Meier analysis. Most patients were seizure free at 12 hours: LZP 60.0%, BRV 100 mg 80.0%, BRV 200 mg 80.0%. Rescue medication use at 12 hours was numerically higher for LZP (40.0%; BRV 100 mg 6.7%, BRV 200 mg 13.3%). TEAEs were reported by 31.3%, 40.0%, 20.0% of LZP, BRV 100 mg, BRV 200 mg patients; one LZP patient (6.3%) reported a serious TEAE (seizure cluster).

IV LZP, IV BRV 100 mg, IV BRV 200 mg showed similar efficacy in controlling acute seizures in the EMU. TEAEs were as expected. This exploratory trial suggests a possible role of BRV in this setting.
Authors/Disclosures
Jerzy P. Szaflarski, MD, PhD, FAAN (University of Alabama At Birmingham)
PRESENTER 		Dr. Szaflarski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Pharma. Dr. Szaflarski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LivaNova Inc. Dr. Szaflarski has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PureTech Health. Dr. Szaflarski has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Gidley, Sarli & Marusak, LLP. Dr. Szaflarski has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Szaflarski has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Law Firm. Dr. Szaflarski has stock in AdCel Biopharma, LLC. Dr. Szaflarski has stock in iFovea.
No disclosure on file
Bernhard Greve, MD (UCB Biosciences GmbH) Dr. Greve has received personal compensation for serving as an employee of UCB Biosciences. Dr. Greve has stock in UCB Biosciences.
No disclosure on file
Julie Varner, PhD (GlaxoSmithKline) No disclosure on file
Brian D. Moseley, MD Dr. Moseley has received personal compensation for serving as an employee of UCB. Dr. Moseley has received personal compensation for serving as an employee of Neurocrine Biosciences Inc. Dr. Moseley has stock in UCB. Dr. Moseley has stock in Neurocrine Biosciences.