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Volume 10
Journal of Neurology & Neurophysiology
ISSN: 2155-9562
Neurology Congress 2019
Vascular Dementia Congress 2019
July 22-24, 2019
JOINT EVENT
conferenceseries
.com
July 22-24, 2019 London, UK
&
12
th
International Conference on
Vascular Dementia
32
nd
European Neurology Congress
Study 506 – third interim analysis of a retrospective, phase IV study of perampanel in real-world clinical
care of patients with epilepsy: Paediatric subgroup (aged <12 years)
Manoj Malhotra
1
, Katherine Moretz
2
, James Wheless
3
, Eric Segal
4
, Marcelo Lancman
4
, Anna Patten
5
and
Betsy Williams
1
1
Eisai Inc., USA
2
Meridian Clinical Research, USA
3
University of Tennessee, USA
4
Northeast Regional Epilepsy Group, USA
5
Eisai Ltd., UK
P
erampanel is given daily once orally as anti-seizure drug for partial-onset seizures (POS) and primary
generalised tonic clonic seizures. We report second interim results for paediatric patients from the multicentre,
non-interventional, Phase IV, retrospective study 506 (NCT03208660), to assess retention rate, safety and dosing
experience of perampanel administered to patients with epilepsy during routine clinical care. Data were obtained
from medical records of patients initiating perampanel after 1 January 2014. Primary endpoint is retention rate
(proportion of patients in Safety Analysis Set [SAS] remaining on perampanel). Safety, efficacy and dosing experience
are secondary objectives. Interim SAS comprised 605 patients; 68 were aged <12 years (mean age [standard deviation
(SD)], 6.7[3.0] years). Seizure types included: complex partial, n=33 (48.5%); POS with secondary generalization,
n=11(16.2%); generalized tonic-clonic, n=21 (30.9%). Mean (SD) cumulative duration of exposure to perampanel
was 14.3(11.5) months and mean (SD) maximum perampanel dose was 5.4(3.2) mg. At data cut-off (5 March 2018),
34(50.0%) paediatric patients remained on perampanel 33(48.5%) had discontinued, primarily due to adverse event
(AE; n=15 [22.1%]) and inadequate therapeutic effect (n=11 [16.2%]). Retention rates at 3, 6, 12, 18 and 24 months
were 82.4% (n=56/68), 66.2% (n=43/65), 61.0% (n=36/59), 53.2% (n=25/47) and 48.6% (n=17/35), respectively.
Treatment emergent AEs occurred in 39.7% of patients; most common were abnormal behavior, aggression and
irritability (all 5.9%). This subgroup analysis suggests that daily oral doses of adjunctive perampanel are generally
well tolerated, with favorable retention rates for ≤2 years in pediatric patients (<12 years) with epilepsy.
Biography
Manoj Malhotra received his Medical Degree fromWayne State University in Detroit, Michigan. He completed his Neurology residency and two fellowships at The
Cleveland Clinic in Cleveland, Ohio. He is the Vice President, Head of MedicalAffairs for the Neurology Business Group at Eisai Inc. He is responsible for Medical
Affairs activities for theAmericas and is Global Medical Lead for Epilepsy. He holds six neurology board certifications (neurology, epilepsy, sleep medicine, clinical
neurophysiology, vascular neurology and electrodiagnostic medicine) and has extensive experience in neurodegenerative diseases, rare diseases and epilepsy.
His industry experience includes working at Novartis, Takeda and Mallinckrodt.
Manoj_Malhotra@eisai.comManoj Malhotra et al., J Neurol Neurophysiol 2019, Volume 10