Randomized phase III study 306

Krauss, Gregory L.; Serratosa, Joan; Villanueva, Vicente; Endzinienė, Milda; Hong, Zhen; French, Jacqueline; Huang, Yang; Squillacote, David; Edwards, Hannah; Zhu, Jin; Laurenza, Antonio

doi:10.1212/wnl.0b013e318254473a

Cited by 391 publications

(563 citation statements)

References 11 publications

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“…2013) and 306 [NCT00700310] (Krauss et al. 2012); Fig. 1), comprising a study population of adults and adolescents (age 12–17 years) were done to establish the minimum effective dose and the dose range (2–12 mg) of once‐daily perampanel.…”

Section: Discussionmentioning

confidence: 99%

“…Study 306 assessed the low to middle dose range (2, 4, and 8 mg) (Krauss et al. 2012). The two other trials, studies 304 and 305, had identical methodology and assessed the higher daily doses of 8 and 12 mg (French et al.…”

Section: Discussionmentioning

confidence: 99%

“…2012, 2013; Krauss et al. 2012). Of these, 145 adolescent patients were randomized to adjunctive therapy with either perampanel ( n = 100) or placebo ( n = 45); 143 received ≥1 dose of study drug and were included in the analysis.…”

Section: Discussionmentioning

confidence: 99%

“…2012, 2013; Krauss et al. 2012). Seizure frequency and responder rate data supported an effective dose range of perampanel, 4–12 mg in adolescent patients, providing seizure reduction in patients with refractory partial‐onset seizures (Fig.…”

Section: Discussionmentioning

confidence: 99%

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Review of clinical studies of perampanel in adolescent patients

et al. 2016

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AimTo assess the clinical trial and real‐world data for adjunctive perampanel in adolescents and develop consensus recommendations to guide the use of perampanel in this population in clinical practice.MethodsIn May 2015, 15 epilepsy experts attended a Consensus Development Meeting to assess the clinical trial data for perampanel, specific to the adolescent age group (12‐17 years) and develop consensus treatment recommendations.Results and DiscussionAnalysis of the adolescent subgroup data of three pivotal placebo‐controlled, double‐blind, phase 3 trials investigating perampanel in patients with ongoing focal epileptic seizures despite receiving one to three antiepileptic drugs found that perampanel 4–12 mg was superior to placebo. The tolerability profile of perampanel was generally acceptable. Adolescent patients receiving long‐term treatment with perampanel in an open‐label extension study maintained improvements in seizure control compared with baseline, with a favorable risk‐benefit profile. A phase 2 study showed that perampanel had no clinically important effects on cognitive function, growth, and development.ConclusionPerampanel is a welcome addition to the armamentarium of existing antiepileptic drugs as it represents a new approach in the management of epilepsy, with a novel mechanism of action, and the potential to have a considerable impact on the treatment of adolescents with epilepsy.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Review of clinical studies of perampanel in adolescent patients

et al. 2016

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“…All studies were conducted in accordance with the Helsinki Declaration, European Medicines Agency requirements, and the U.S. Code of Federal Regulations, as appropriate. All subjects provided written informed consent prior to participation 4, 5, 6…”

Section: Methodsmentioning

confidence: 99%

Perampanel efficacy and safety by gender: Subanalysis of phase III randomized clinical studies in subjects with partial seizures

et al. 2015

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SummaryThe antiepileptic drug (AED) perampanel is approved in ≥40 countries as adjunctive therapy for drug‐resistant partial seizures in patients with epilepsy. This post hoc analysis of pooled data from three phase III, double‐blind, randomized studies of perampanel examines between‐gender differences in perampanel efficacy and safety. Of the 1,478 subjects in the pooled analysis (719 male, 759 female), 1,109 were included in the pharmacokinetic/pharmacodynamic analysis. Perampanel oral clearance was 17% lower in female than in male patients not receiving enzyme‐inducing AEDs. Pooled efficacy analysis revealed that seizure frequency was reduced with perampanel treatment regardless of gender; a greater numerical reduction in seizure frequency and increased responder rates occurred in female participants at perampanel doses of 4, 8, and 12 mg. Tolerability was similar between groups, although common adverse events such as dizziness and headache occurred more frequently in female subjects. Modest elevations in perampanel exposure in female patients may result in meaningful between‐gender differences in efficacy and safety; therefore, dosing should be individualized and clinical response monitored.

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