Leock Y. Ngo, Mathieu Milh, Robert Flamini, Andras Fogarasi, Steven Phillips, Shinsaku Yoshitomi Anna Patten and Takao Takase
Eisai Inc., USA
Timone Infant Hospital, France
Pediatric and Adolescent Neurodevelopmental Associates, USA
Bethesda Children’s Hospital, Hungary
Mary Bridge Children's Neurology Clinic, USA6
Shizuoka Institute of Epilepsy and Neurological Disorders, Japan
Eisai Ltd., UK
Eisai Co., Ltd., Japan
Posters & Accepted Abstracts: J Neurol Neurophysiol
Study 311 (NCT02849626) assessed 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 primary generalised tonic-clonic seizures. Here, we report Core Study safety and efficacy data stratified by concomitant Baseline EIASD use. The Core Study consisted of 4-week Pre-treatment, 23-week Treatment and 4-week Follow-up Periods. Patients must have been on stable doses of 1â??3 concomitant ASDs; 1 EIASD (carbamazepine, oxcarbazepine, eslicarbazepine or phenytoin) was permitted. Perampanel was titrated to â?¤16 mg/day for EIASD and â?¤12 mg/day for non-EIASD patients (â?¤12 mg/day in Japanese patients, irrespective of EIASD status). In total, 180 patients (EIASD, n=48; non-EIASD, n=132) received â?¥1 perampanel dose. The most common EIASDs were carbamazepine (14%) and oxcarbazepine (11%). Treatment-emergent adverse events were reported in 40 (83.3%) patients with and 120 (90.9%) patients without EIASDs; most common were somnolence and nasopharyngitis. Median percent reduction in seizure frequency per 28 days from Baseline with vs without EIASDs was 34.0% vs 42.2%, respectively, for POS, and 59.5% vs 57.8%, respectively, for SGS. 50% responder rates were similar between patients with vs without EIASDs (POS: 45.7% vs 47.1%; SGS: 54.5% vs 67.4%, respectively). Seizurefreedom rates with vs without EIASDs were 10.9% vs 11.8%, respectively, for POS, and 9.1% vs 20.9%, respectively, for SGS. In this subanalysis, adjunctive perampanel was generally well tolerated and efficacious in patients aged 4 to <12 years with POS, with/without SGS, regardless of Baseline concomitant EIASD status.
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.
E-mail: stella_ngo@eisai.com
