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Review of clinical studies of perampanel in adolescent patients

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Related in: MedlinePlus

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.
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brb3505-fig-0003: 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.

Mentions: The pooled data from the three trials show that, in perampanel‐treated adolescents, efficacy outcomes for the adolescent age group (12–17 years) were consistent with the overall findings of the phase 3 studies (French et al. 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. 3).


Review of clinical studies of perampanel in adolescent patients
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.
© Copyright Policy - creativeCommonsBy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5036429&req=5

brb3505-fig-0003: 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.
Mentions: The pooled data from the three trials show that, in perampanel‐treated adolescents, efficacy outcomes for the adolescent age group (12–17 years) were consistent with the overall findings of the phase 3 studies (French et al. 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. 3).

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Related in: MedlinePlus