Abstract Details

Title Open-Label Pilot Study of Adjunctive Lacosamide for Patients with Uncontrolled Primary Generalized Tonic-Clonic Seizures

Topic Epilepsy

Presentation(s) (-)

Poster/Presentation
Number 010

Objective

Background Lacosamide is an anti-epileptic drug (AED) approved for adjunctive treatment of partial-onset seizures (POS) in adults. Lacosamide is under investigation for other seizure types.

Design/Methods This Phase 2, multicenter, open-label pilot study (SP0961) included a 4-week prospective Baseline, 3-week Titration, and 6-week Maintenance. Dose titration started at 100mg/day, increasing weekly to 400mg/day maximum. Primary variables were change in number of seizure days/28 days from prospective Baseline to Maintenance for absence and myoclonic seizures. Other variables included percent change from combined Baseline (12-week retrospective period+4-week prospective Baseline) in 28-day seizure frequency for PGTCS, changes in 24-hour ambulatory EEG, and treatment-emergent adverse events (TEAEs).

Results Of 49 patients enrolled, 40 (81.6%) completed the study. At Baseline, 69.4% were taking 2-3 concomitant AEDs. All had a history of PGTCS; 69.4% and 55.1% had a history of absence and myoclonic seizures, respectively. At prospective Baseline, mean absence and myoclonic seizure days/28 days were 4.7±8.48 and 4.7±7.98, respectively. Mean change from prospective Baseline to Maintenance was -0.37±4.80 (mean percent change of -10.63±76.3) for absence and -2.19±5.80 (mean percent change of -44.95±73.9) for myoclonic seizures. Mean percent change (combined Baseline to Maintenance) was -26.37±156.16 for PGTC 28-day seizure frequency; 29 (59.2%) patients had no PGTCS during Maintenance. Frequently reported TEAEs were dizziness, nausea, headache, somnolence. Five patients (10.2%) reported increases in absence seizures as TEAEs. There was no consistent correlation between changes in EEG discharges and clinical outcome.

Conclusions Adjunctive lacosamide appears to be safe in this population, as it did not systematically worsen absence or myoclonus. Reductions in PGTCS frequency were observed. TEAEs were similar to those observed among patients with POS, except seizure-related events. These results support further evaluation of lacosamide for PGTCS.

Authors/Disclosures
Robert T. Wechsler, MD, PhD, FAAN (Consultants in Epilepsy & Neurology) PRESENTER	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 Raport. 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. 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 a non-compensated relationship as a Board President with Epilepsy Foundation of Idaho that is relevant to AAN interests or activities.
Robert F. Leroy, MD	No disclosure on file
	No disclosure on file
Pamela Doty, PhD	No disclosure on file
David S. Knopman, MD, FAAN (Mayo Clinic)	Dr. Knopman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for DIAN TU study. The institution of Dr. Knopman has received research support from NIH.

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