Abstract Details

Title Time-course of Treatment-emergent Adverse Events Potentially Associated with Behavioral Disorders during Adjunctive Brivaracetam Treatment of Adults with Focal Seizures

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P17 - Poster Session 17 (11:45 AM-12:45 PM)

Poster/Presentation
Number 10-003

Objective To assess the time-course of treatment-emergent adverse events (TEAEs) potentially associated with behavioral disorders (BAEs) in adults with focal seizures during adjunctive brivaracetam (BRV) treatment.

Background Drug-related central nervous system TEAEs occur early in the course of adjunctive BRV treatment and diminish over time (Meador et al., Epilepsy Behav 2020).

Design/Methods Post-hoc analysis of three Phase III, double-blind, placebo (PBO)-controlled trials of adjunctive BRV in patients (≥16 years) with focal seizures (N01252 [NCT00490035], N01253 [NCT00464269], N01358 [NCT01261325]). Incidence, prevalence, and discontinuation due to BAEs were assessed over time (12 weeks) in patients randomized to BRV (50–200 mg/day without titration) or PBO.

Results 803 patients randomized to BRV and 459 to PBO were assessed. During 12-week treatment, 4.6% patients on BRV and 1.5% on PBO reported ≥1 BAE; mainly of mild or moderate intensity (BRV: 89.2%; PBO: 85.7%) with incidences similar in patients on BRV 50, 100, and 200 mg/day (6.0%, 4.2%, 4.0%, respectively). During BRV treatment, most BAEs began within the first 5 weeks with highest incidence during week 2 (1.6%) which decreased thereafter; prevalence increased from week 1 (1.0%) to 5 (3.2%), decreased slightly and remained generally stable during weeks 6–12 (range 2.3–2.9%). The most frequent BAEs on BRV (≥0.5%) were irritability (3.2% [PBO 0.7%]), aggression (0.5% [PBO 0.4%]), and agitation (0.5% [PBO 0]). 0.7% patients on BRV and 0.2% on PBO discontinued due to BAEs (weeks 2−9). Of patients who reported ≥1 BAE, 81.1% on BRV and 57.1% on PBO continued open-label treatment.

Conclusions During adjunctive BRV treatment, BAEs were reported in 4.6% of adults with focal seizures, were not dependent on BRV dose, and had an onset mainly during the first 5 weeks. Most patients who reported BAEs continued long-term BRV treatment.

Authors/Disclosures
Kimford J. Meador, MD, FAAN (Stanford University School of Medicine) PRESENTER	The institution of Dr. Meador has received research support from NIH. The institution of Dr. Meador has received research support from The Epilepsy Consortium.
	No disclosure on file
Cedric Laloyaux, PhD (UCBMedical Affairs Center of Expertise)	Dr. Laloyaux has received personal compensation for serving as an employee of UCB.
	No disclosure on file
Florin Floricel (UCB Biosciences GmbH)	No disclosure on file
	No disclosure on file
Pavel Klein, MD, FAAN (Mid-atlantic Epilepsy and Sleep Center)	The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurelis. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB Pharma. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Sience. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alliance. The institution of Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle Therapeutics. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Aquestive. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for UCB Pharma. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for SK Life Sciences. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion. Dr. Klein has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for PrevEp. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Fenwick . Dr. Klein has received research support from DOD/CURE.

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