Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures: An Open-label Extension Study (P3.276)
`
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`psychosis unrelated to the
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`April 29, 2014
`Poster Session III
`Epilepsy and Clinical Neurophysiology: AED
`
`Lacosamide for Uncontrolled Primary
`Generalized Tonic-Clonic Seizures: An
`Open-label Extension Study (P3.276)
`
`Stephen Yates2, Robert Wechsler1 and Cynthia Beller2
`
`+
`
`SHOW AFFILIATIONS
`
`Published online before print April 8, 2015,
`Neurology April 8, 2014 vol. 82 no. 10 Supplement P3.276
`
`Abstract
`
`ABSTRACT
`
`OBJECTIVE:This open-label extension (OLE) study (SP0962 [NCT01118962]) assessed long-term (>12-months)
`safety of adjunctive lacosamide in patients (16-65y) with idiopathic-generalized epilepsy (IGE) and uncontrolled
`tonic-clonic seizures (PGTCS). BACKGROUND:Safety of adjunctive
`lacosamide
`for
`primary generalized
`uncontrolled PGTCS in IGE was reported in a 13-week, Phase 2, open-label, pilot study (SP0961 [NCT01118949]).
`Patients completing SP0961 could enroll in SP0962. DESIGN/METHODS:Initial lacosamide dose for SP0962 was
`that received at end of SP0961 (300 or 400mg/day), and could be increased (up to 800mg/day) or decreased
`throughout SP0962 56-week Treatment Period. New AEDs approved for PGTCS could be introduced, as needed.
`Primary variables were treatment-emergent adverse-events (TEAEs) and withdrawals due to TEAEs. Secondary
`variables included: percentage-change in PGTCS frequency/28days from Baseline (SP0961 4-week Prospective or
`16-week Combined [12-week Historical+4-week Prospective]); change from Prospective-Baseline in absence or
`myoclonic seizure days/28days; continuous 6-months or 1-year freedom from PGTCS. RESULTS:39/40 patients
`who completed SP0961 enrolled in SP0962 (30.3y; 72% female). All had history of PGTCS within 12-weeks of
`enrollment, 67% of absence, and 54% of myoclonic-seizures. 79% were taking 1-2 concomitant AEDs. 29/39
`patients (74%) completed OLE. 32/39 (82%) had >12 months lacosamide exposure. Mean modal lacosamide dose
`was 428.2mg/day. 37/39 patients (95%) reported 蠅1 TEAE. Most frequent were: dizziness (26%), upper respiratory
`tract infection (26%), headache (18%), tremor (15%). Two patients discontinued prematurely due to TEAEs
`(abnormal behavior; confusional state). One patient each experienced TEAE increased absence-seizures and
`increased myoclonic-seizures. Mean±SD reduction from Prospective-Baseline in absence and myoclonic seizure
`days/28 days was -2.4±5.5 and -2.8±6.4 [Prospective-Baseline: absence 4.9±9.1; myoclonic 4.3±7.7]. Median
`percentage-change in PGTCS frequency/28 days was -89.3% (from Prospective-Baseline) and -72.3% (from
`Combined-Baseline). 25/39 patients (64%) were free from PGTCS for 蠅6-months, and 14/39 (36%) for 蠅1-year.
`
`http://www.neurology.org/content/82/10_Supplement/P3.276
`
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`with dementia-related psychosis unrelated to the
`hallucinations and delusions associated with Parkinson’s
`disease psychosis.
`QT Interval Prolongation: NUPLAZID prolongs the QT interval.
`The use of NUPLAZID should be avoided in patients with known
`QT prolongation or in combination with other drugs known to
`prolong QT interval including Class 1A antiarrhythmics or Class
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2086 - 1/2
`
`

`
`Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures: An Open-label Extension Study (P3.276)
`
`CONCLUSIONS:No new safety signals were identified following >12-months adjunctive lacosamide treatment in
`patients with IGE. Lacosamide reduced PGTCS frequency, and generally reduced days with absence and
`myoclonic seizures. Results support further evaluation of lacosamide for PGTCS. Study Supported by:UCB
`Pharma
`
`Disclosure: Dr. Yates has received personal compensation for activities with UCB Pharma. Dr. Yates holds stock
`and/or stock options in UCB Pharma. Dr. Wechsler has received personal compensation for activities with USB
`Pharma, GlaxoSmithKline Inc., Lundbeck, Cyberonics, Eisai Inc., Gerson Lehrman Group, Jazz Pharmaceuticals,
`Upsher-Smith Laboratories Inc. Dr. Wechsler has received research support from UCB Pharma, Lundbeck, Eisai
`Inc., Vertex, Icagen, King Pharmaceuticals, Sunovion Pharmaceuticals, Upsher-Smith Laboratories Inc., Pfizer Inc.,
`and GlaxoSmithKline Inc. Cynthia Beller has received personal compensation for activities with UCB BioSciences,
`Inc. as an employee.,
`
`Tuesday, April 29 2014, 3:00 pm-6:30 pm
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`Copyright © 2014 by AAN Enterprises, Inc.
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`http://www.neurology.org/content/82/10_Supplement/P3.276
`
`Argentum Pharm. v. Research Corp. Techs., IPR2016-00204
`RCT EX. 2086 - 2/2