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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.


Percentile change from baseline in (A) weight and (B) height.
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brb3505-fig-0005: Percentile change from baseline in (A) weight and (B) height.

Mentions: Overall, perampanel did not negatively impact growth and development compared with placebo (Pina‐Garza et al. 2015). Mean change in weight percentile decreased slightly for placebo (baseline (49.9%) to end of treatment (49.1%), −1.0; standard deviation [SD]: 4.9) and increased slightly for perampanel (baseline (46.1%) to end of treatment (48.0%), 1.9; SD: 6.7). Mean change in height percentile was similar for both the placebo (baseline (47.5%) to end of treatment (47.7%), −0.7; SD: 8.2) and perampanel groups (baseline [44.1%] to end of treatment [43.4%], −0.8; SD: 5.9; Fig. 5). The sex‐ and age‐specific percentiles for weight and height were calculated from the Centers for Disease Control and Prevention Growth Charts (Centers for Disease Control and Prevention). Insulin‐like growth factor‐1 (IGF‐1) decreased minimally with perampanel treatment (−1.1; SD: 113.9) and to a greater extent with placebo treatment (−13.9; SD: 93.9). There were minimal or no changes from baseline for thyrotropin, free thyroxin, and free triiodothyronine, with no difference between treatment groups. There were no clinically important changes in bone age from baseline to the end of treatment. When compared with placebo, perampanel did not negatively affect sexual development in either males or females (Tanner staging; Marshall and Tanner 1970).


Review of clinical studies of perampanel in adolescent patients
Percentile change from baseline in (A) weight and (B) height.
© Copyright Policy - creativeCommonsBy
Related In: Results  -  Collection

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

brb3505-fig-0005: Percentile change from baseline in (A) weight and (B) height.
Mentions: Overall, perampanel did not negatively impact growth and development compared with placebo (Pina‐Garza et al. 2015). Mean change in weight percentile decreased slightly for placebo (baseline (49.9%) to end of treatment (49.1%), −1.0; standard deviation [SD]: 4.9) and increased slightly for perampanel (baseline (46.1%) to end of treatment (48.0%), 1.9; SD: 6.7). Mean change in height percentile was similar for both the placebo (baseline (47.5%) to end of treatment (47.7%), −0.7; SD: 8.2) and perampanel groups (baseline [44.1%] to end of treatment [43.4%], −0.8; SD: 5.9; Fig. 5). The sex‐ and age‐specific percentiles for weight and height were calculated from the Centers for Disease Control and Prevention Growth Charts (Centers for Disease Control and Prevention). Insulin‐like growth factor‐1 (IGF‐1) decreased minimally with perampanel treatment (−1.1; SD: 113.9) and to a greater extent with placebo treatment (−13.9; SD: 93.9). There were minimal or no changes from baseline for thyrotropin, free thyroxin, and free triiodothyronine, with no difference between treatment groups. There were no clinically important changes in bone age from baseline to the end of treatment. When compared with placebo, perampanel did not negatively affect sexual development in either males or females (Tanner staging; Marshall and Tanner 1970).

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.