Leock Y. Ngo, Andras Fogarasi, Robert Flamini, Mathieu Milh, Steven Phillips, Shinsaku Yoshitomi, Anna Patten and Takao Takase
Eisai Inc., USA
Epilepsy Centre, Bethesda Children’s Hospital, Hungary
Pediatric and Adolescent Neurodevelopmental Associates, USA
La Timone-Enfants Hospital, France
Mary Bridge Children’s Neurology Clinic, USA
Shizuoka Institute of Epilepsy and Neurological Disorders, Japan
Eisai Ltd., UK
Eisai Co., 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 PGTCS. Here, we report core study safety and efficacy data stratified by age (Cohort 1: 4 to <7 years; Cohort 2: 7 to <12 years). The core study included 4-week pre-treatment, 23-week treatment and 4-week follow-up periods. Primary endpoints were safety and tolerability. Secondary endpoints included median percent change in seizure frequency per 28 days from baseline, and 50% responder and seizure-freedom rates during maintenance. In total, 180 patients received â?¥1 perampanel dose (Cohort 1: n=46; Cohort 2: n=134). Treatmentemergent adverse events were reported by 45 (97.8%; Cohort 1) and 115 (85.8%; Cohort 2) patients; most common were somnolence, nasopharyngitis, dizziness and irritability. Full analysis set, cohort 1 vs., 2: POS, n=40 vs 108; SGS, n=17 vs 37; PGTCS, n=3 vs 19, respectively. Median percent reduction in seizure frequency per 28 days from baseline for POS, PGTCS and SGS, Cohort 1 vs 2: 42.7%, 56.5%, 56.3% vs 40.1%, 81.9%, 60.6%, respectively. 50% responder rates were similar between cohorts for POS, PGTCS and SGS (Cohort 1: 45.0%, 66.7%, 70.6% vs., cohort 2: 47.2%, 63.2%, 62.2%, respectively). Seizure-freedom rates for POS, PGTCS and SGS, Cohort 1 vs., 2: 7.5%, 66.7%, 17.6% vs., 13.0%, 52.6%, 18.9%, respectively. Adjunctive perampanel was generally well tolerated and efficacious in patients 4 to <7 and 7 to <12 years with POS, PGTCS or SGS.
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: [email protected]