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Abstract Details

Post Hoc Univariate and Multivariate Analyses to Identify Clinical Factors Associated with a 50% or 75% Response in a Phase III Trial of Adjunctive Perampanel in Patients with Primary Generalized Tonic-Clonic Seizures (PGTCS)
Epilepsy/Clinical Neurophysiology (EEG)
P13 - Poster Session 13 (5:30 PM-6:30 PM)
12-005
Identify predictive factors for achieving a 50% or 75% response to treatment (placebo or perampanel 8 mg/day) in patients (aged ≥12 years) with drug-resistant PGTCS during Study 332 (NCT01393743).
Perampanel is a once-daily oral anti-seizure medication (ASM) for partial-onset seizures and PGTCS. There are limited data that allow identification of important predictors of response to ASMs.
Patients were randomized to receive placebo or adjunctive perampanel 8 mg/day across a Double-blind Phase (4-week Titration; 13-week Maintenance). Univariate analysis using logistic regression was performed to identify clinical factors associated with a 50% or 75% response during the Maintenance Period (defined as a ≥50% or ≥75% reduction in seizure frequency per 28 days from baseline). Significant predictors at the univariate level were included in a multivariate model.
Overall, 84 patients had a 50% response (placebo, n=32; perampanel, n=52) and 58 patients had a 75% response (placebo, n=19; perampanel, n=39). At the univariate level, significant predictors of a 50% or 75% response were: lower baseline PGTCS frequency (P=0.0112 and P=0.0141, respectively) and presence of baseline absence seizures (P=0.0264 and P=0.0317, respectively). Number of baseline ASMs, myoclonic seizures at baseline, presence/absence of enzyme-inducing ASMs at baseline, and age at diagnosis were not significantly associated with a response; increasing time since diagnosis showed borderline significance for the 50% response (P=0.0505) but not for 75% response. In the multivariate model, the best predictors of a 50% or 75% response were perampanel treatment (P=0.0002 and P=0.0003), lower baseline seizure frequency (P=0.0134 and P=0.0172), and presence of baseline absence seizures (P=0.0262 and P=0.0431); increasing time since diagnosis was also a predictor of a 50% response (P=0.0471).

These analyses identified potential predictive factors for patients with PGTCS achieving a 50% or 75% response, which may help guide clinicians when predicting a patient’s response to treatment.

Funding: Eisai Inc.
Authors/Disclosures
Christian Brandt, MD (Bethel Epilepsy Center, Mara Hospital)
PRESENTER 		Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW. Dr. Brandt has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Desitin. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Arvelle. Dr. Brandt has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Dr. Brandt has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eisai. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Zogenix. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for GW. Dr. Brandt has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Arvelle. The institution of Dr. Brandt has received research support from Rubin-Stiftung. Dr. Brandt has received publishing royalties from a publication relating to health care.
Gregory Krauss, MD (Johns Hopkins University) Dr. Krauss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Arvelle. Dr. Krauss has received stock or an ownership interest from EpiWatch.
Robert T. Wechsler, MD, PhD, FÂ鶹´«Ã½Ó³»­ (Consultants in Epilepsy & Neurology) The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Otsuka. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Science. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Engage. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eliem. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Epalex. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engrail. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Equilibre. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rapport. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurona. Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurelis. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sunovion. Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for UCB. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Greenwich/Jazz. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eisai. Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aquestive. Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science. Dr. Wechsler has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Epilepsy Studies Consortium. Dr. Wechsler has a non-compensated relationship as a Board President with Epilepsy Foundation of Idaho that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
No disclosure on file
No disclosure on file
Manoj Malhotra, MD Dr. Malhotra has received personal compensation for serving as an employee of Eisai.