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Review
. 2016 Jun 28;6(9):e00505.
doi: 10.1002/brb3.505. eCollection 2016 Sep.

Review of clinical studies of perampanel in adolescent patients

Heung Dong Kim  1 , Ching-Shiang Chi  2 , Tayard Desudchit  3 , Marina Nikanorova  4 , Anannit Visudtibhan  5 , Charcrin Nabangchang  6 , Derrick W S Chan  7 , Choong Yi Fong  8 , Kai-Ping Chang  9 , Shang-Yeong Kwan  10 , Fe De Los Reyes  11 , Chao-Ching Huang  12 , Surachai Likasitwattanakul  13 , Wang-Tso Lee  14 , Ada Yung  15 , Amitabh Dash  16
Affiliations
Review

Review of clinical studies of perampanel in adolescent patients

Heung Dong Kim et al. Brain Behav. .

Abstract

Aim: To 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.

Methods: In 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 discussion: Analysis 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.

Conclusion: Perampanel 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.

Keywords: Adolescent; Anticonvulsants; consensus; epilepsy; perampanel; receptors AMPA.

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Figures

Figure 1
Figure 1
Design overview of three randomized controlled phase 3 trials and an open‐label extension study of perampanel. AED, antiepileptic drug; MTD, maximum tolerated dose. *Studies 304 (French et al. 2012), 305 (French et al. 2013), and 306 (Krauss et al. 2012). †Study 307 (Krauss et al. 2013).
Figure 2
Figure 2
Design of a phase 2 study of perampanel (study 235) (Hussein et al. 2015; Pina‐Garza et al. 2015; Renfroe et al. 2015). R, randomization. 1All patients were retained to the last visit of extension part A. 2Part B was optional (a patient proceeded to or completed part B if perampanel was not commercially available or extended‐access program 401 was not in place in their country of residence). 3Follow‐up was conducted for all patients 4 weeks after their last on‐treatment visit.
Figure 3
Figure 3
Pooled efficacy data from pivotal phase 3 studies 304 (French et al. 2012), 305 (French et al. 2013), and 306 (Krauss et al. 2012). (A) Median percentage change in seizure frequency per 28 days of treatment versus baseline; (B) 50% responder rates; and (C) median percentage change for complex partial seizures plus secondarily generalized seizures (Steinhoff et al. 2013). The subanalysis was not powered for statistical analysis.
Figure 4
Figure 4
Responder rates in the open‐label extension study 307 (Krauss et al. 2013; Rosenfeld et al. 2015). CP, complex partial; SG, secondarily generalized.
Figure 5
Figure 5
Percentile change from baseline in (A) weight and (B) height.
See this image and copyright information in PMC

References

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