Long‐term safety and efficacy of adjunctive perampanel in pediatric patients (ages 4 to <12 years) with inadequately controlled focal‐onset seizures or generalized tonic–clonic seizures
Rattachement africain : us, hu, fr, gb, jp. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
OBJECTIVE: Study 311 (NCT02849626) Extension A assessed long-term outcomes of adjunctive perampanel treatment in children (ages 4 to <12 years) with uncontrolled focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), or generalized tonic-clonic seizures (GTCS). METHODS: Patients completing the 23-week Core Study could enter Extension A (29-week Maintenance and 4-week Follow-up Periods) to receive perampanel at the dose achieved during the Core Study. Dose adjustments were permitted per the investigator's discretion during Extension A. The maximum dose was 12 mg/day for patients enrolled in Japan and without enzyme-inducing anti-seizure medications (EIASMs), or 16 mg/day with EIASM(s). Safety and tolerability were monitored throughout Extension A. Efficacy assessments included median percent change in seizure frequency per 28 days from baseline and 50% responder rates. Outcomes were analyzed by seizure type, age (4 to <7 vs 7 to <12 years), and EIASM use. RESULTS: Of 180 patients enrolling in the Core Study, 136 entered (FOS, n = 116 [including 43 with FBTCS]; GTCS, n = 20) and 122 completed Extension A. Treatment-emergent adverse events (TEAEs) were the most common reason for discontinuation (4%). The mean (standard deviation) dose during Extension A was 8.3 (3.2) mg/day. Incidences of TEAEs in Extension A were 69% overall and 62%-89% across subgroups; TEAEs led to dose adjustment in 10% of patients. No changes of clinical concern in cognition, growth, development, or quality of life were identified over 52 weeks. At Weeks 40-52, median percent reductions in seizure frequency per 28 days from baseline were 69% (FOS, n = 108), 74% (FBTCS, n = 41), and 100% (GTCS, n = 13); 50% responder rates were 62% (FOS and GTCS) and 81% (FBTCS). Efficacy outcomes were comparable across age and EIASM groups. SIGNIFICANCE: These findings support long-term (≤52 weeks) use of adjunctive perampanel in children with epilepsy, irrespective of seizure type, age, or EIASM use.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Long‐term safety and efficacy of adjunctive perampanel in pediatric patients (ages 4 to <12 years) with inadequately controlled focal‐onset seizures or generalized tonic–clonic seizures
- Date Crossref
- 11/02/2025
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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NeuroDevelopment Center pays non établi dans la noticeStructure de recherche
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Semmelweis University pays non établi dans la noticeUniversité ou école supérieure
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Hôpital de la Timone pays non établi dans la noticeÉtablissement de santé
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Mary Bridge Children's Health Center pays non établi dans la noticeÉtablissement de santé
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Eisai (United Kingdom) pays non établi dans la noticeEntreprise
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Eisai (Japan) pays non établi dans la noticeEntreprise
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Eisai (United States) pays non établi dans la noticeEntreprise
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Pediatric and Adolescent Neurodevelopmental Associates Atlanta Georgia USA pays non établi dans la noticeInstitution
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Andras Peto Faculty pays non établi dans la noticeUniversité ou école supérieure
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Yokohama Medical and Welfare Centre Konan Yokohoma Japan pays non établi dans la noticeInstitution
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Pediatric Neurology Unity La Timone Enfants Hospital Marseille France Pediatric Neurology Unity pays non établi dans la noticeÉtablissement de santé
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Mary Bridge Children's Neurology Clinic Tacoma Washington USA pays non établi dans la noticeÉtablissement de santé
NeuroDevelopment Center, Semmelweis University et Hôpital de la Timone, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.