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Page 35
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
&
12th International Conference on Vascular Dementia
32nd European Neurology Congress
Safety and efficacy of adjunctive perampanel in paediatric patients (aged 4 to ˂12 years) with partial-
onset seizures (POS) or primary generalised tonic-clonic seizures (PGTCS): Final results from the 311
core study
Leock Y. Ngo1, Robert Flamini2 , Andras Fogarasi3, Mathieu Milh4, Steven Phillips5, Shinsaku Yoshitomi6, Anna Patten7, Takao Takase 8 and Antonio
Laurenza1
1Eisai Inc., USA
2Pediatric and Adolescent Neurodevelopmental Associates, USA
3Epilepsy Centre, Bethesda Children's Hospital, Hungary
4La Timone-Enfants Hospital, France
5Mary Bridge Children's Neurology Clinic, USA
6Shizuoka Institute of Epilepsy and Neurological Disorders, Japan
7Eisai Ltd., UK
8Eisai Co., Ltd., Japan
P erampanel is a once-daily oral anti-seizure drug for POS and PGTCS. Study 311 (NCT02849626) is a global,
multicentre, open-label, single-arm study assessing the safety, tolerability, pharmacokinetics and efficacy of once-
daily adjunctive perampanel oral suspension in patients aged 4 to <12 years with POS (with/without secondarily
generalised seizures [SGS]) or PGTCS. We report safety, tolerability and efficacy data from the 311 Core Study. This
study included a 4-week Pre-treatment Period, 23-week Treatment Period and 4-week Follow-up Period. Primary
endpoints were safety and tolerability. Secondary endpoints included median percent change in seizure frequency
per 28 days from Baseline during the Treatment Period, and 50% responder and seizure-freedom rates during
Maintenance (Core Study) and longer-term treatment (≤52 weeks). In total, 180 patients (POS, n=149; PGTCS,
n=31) received ≥1 perampanel dose (mean age [standard deviation], 8.1 [2.09] years; female, 48.9%); 146 (81.1%)
patients completed the Core Study and 34 (18.9%) discontinued. Adverse events (AEs) were the primary reason
for discontinuation (n=14 [7.8%]). Median (minimum, maximum) dose of perampanel was 8.0 (2, 16) mg/day
and duration of exposure was 22.9 (0, 27) weeks. Treatment-emergent AEs in ≥10% of patients were: somnolence,
nasopharyngitis, dizziness, irritability, pyrexia and vomiting. Median percent reduction in seizure frequency per
28 days from Baseline, 50% responder rates and seizure-freedom rates, respectively, were: POS: 40.1%, 46.6% and
11.5%; PGTCS: 69.2%, 63.6% and 54.5%; SGS: 58.7%, 64.8% and 18.5%. Adjunctive perampanel was generally safe,
well tolerated and efficacious in children aged 4 to <12 years with POS, SGS or PGTCS.
Biography
Leock Y. Ngo has a PhD in Pharmaceutical Sciences from the University of Alberta, Canada and was a Postdoctoral Research Fellow at the University of
Washington in Seattle, Washington. Stella is Director in Clinical Research at Eisai Inc., responsible for the development of new anti-epilepsy drugs. She is the
International Project Lead for Fycompa® and Inovelon®, and the Clinical Lead for new chemical entities in early development for epilepsy treatment. Before
joining Eisai, Stella gained 19+ years’ experience in clinical pharmacology and clinical trials across various therapeutic areas, including neurology (Alzheimer’s
disease and peripheral neuropathy), oncology, pulmonology and autoimmune/inflammatory disorders.
Leock Y. Ngo et al., J Neurol Neurophysiol 2019, Volume 10