Leock Y. Ngo, Robert Flamini, Andras Fogarasi, Mathieu Milh, Steven Phillips, Shinsaku Yoshitomi, Anna Patten, Takao Takase and Antonio Laurenza
Eisai Inc., USA
Pediatric and Adolescent Neurodevelopmental Associates, USA
Epilepsy Centre, Bethesda Children's Hospital, Hungary
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., Ltd., Japan
Scientific Tracks Abstracts: J Neurol Neurophysiol
Perampanel 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 oncedaily 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 (ΓΆΒ?Β¤52 weeks). In total, 180 patients (POS, n=149; PGTCS, n=31) received ΓΆΒ?Β¥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 ΓΆΒ?Β¥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.
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
