Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies—An Italian observational multicenter study

Liso, Paola De; Vigevano, Federico; Specchio, Nicola; Palma, Luca De; Bonanni, Paolo; Osanni, Elisa; Coppola, Giangennaro; Parisi, Pasquale; Grosso, Salvatore; Verrotti, Alberto; Spalice, Alberto; Nicita, Francesco; Zamponi, Nelia; Siliquini, Sabrina; Giordano, Lucio; Martelli, Paola; Guerrini, Renzo; Rosati, Anna; Ilvento, Lucrezia; Belcastro, Vincenzo; Striano, Pasquale; Vari, Maria Stella; Capovilla, Giuseppe; Beccaria, Franca; Bruni, Oliviero; Luchetti, Anna; Gobbi, Giuseppe; Russo, Angelo; Pruna, Dario; Tozzi, Alberto Eugenio; Cusmai, Raffaella

doi:10.1016/j.eplepsyres.2016.08.021

Cited by 65 publications

(88 citation statements)

References 16 publications

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“…Another observational, retrospective study involved 16 tertiary epilepsy centers and retrospectively collected data on 62 children and adolescents who started treatment with perampanel, with a mean follow-up of 6.6 months [20]. Among all analyzed patients, 39 had focal seizures, 10 of whom obtained a ≥ 75% reduction in seizure frequency.…”

Section: Pharmacokinetics and Drug Interactionsmentioning

confidence: 99%

“…Besides patients with focal epilepsies they also included epileptic encephalopathies and epilepsies with both focal and generalized seizures [20]. A separate analysis of efficacy was only made for 6 patients with a definite epileptic syndrome (Dravet syndrome, PCDH19, Lennox-Gastaut and myoclonic astatic epilepsy), and a clinically significant response was observed in half of them [20]. Perampanel efficacy has also been assessed in Lafora disease, in two anecdotal cases (one adult, one adolescent) and in a small series of 10 patients [22–24].…”

Section: Pharmacokinetics and Drug Interactionsmentioning

confidence: 99%

“…A lower incidence of TEAEs was achieved with a slower titration rate, and adverse events were usually reversible with perampanel discontinuation or with dose adjustment. Perampanel was associated with a 10% worsening of seizures mainly related to intensity and duration of seizures rather than to their frequency in a retrospective real-life study [20]; in RCTs seizure worsening (defined as an increase in seizure frequency > 50%) was observed in 8-11% of cases versus 13% of placebo [20, 25]. A single study on 24 children treated with perampanel showed that adverse events were more frequent in children older than 12 years than in younger ones [26].…”

Section: Safety Profilementioning

confidence: 99%

“…Extrapolating data for patients in pediatric age from other observational studies, data on psychiatric adverse events of 355 subjects up to 18 years of age are available. Among them, challenging behavior (including aggressiveness, irritability and general behavioral disturbances) has been described in 11% [18–20, 30, 31]. A relationship between daily dose of perampanel and psychiatric adverse events has been described, with challenging behavior being more common for higher doses up to 12 mg [32].…”

Section: Safety Profilementioning

confidence: 99%

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Current role of perampanel in pediatric epilepsy

et al. 2017

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Perampanel is among the latest AEDs approved, indicated for the treatment of partial-onset seizures with or without secondary generalization, and for primary generalized tonic-clonic seizures, in patients aged 12 years and older. This paper summarizes the clinical recommendations on the current role of perampanel in the treatment of pediatric epilepsies and future directions for research. The optimal dosage should be comprised between 4 and 12 mg/day, with 8 mg/day being the most common dosage used. The rate and severity of adverse events, including psychiatric symptoms, can be decreased by starting at low doses, and titrating slowly. Overall, perampanel presents an acceptable risk/benefit ratio, but special caution should be made to the risk of seizure aggravation and behavioral problems. The favorable cognitive profile, the ease of use of the titration scheme and the once-daily formulation offer advantage over other AEDs and make this drug particularly suitable for adolescent population. Perampanel is a welcome addition to the armamentarium of the existing AEDs, as it represents a new approach in the management of epilepsy, with a novel mechanism of action and a potential to have a considerable impact on the treatment of adolescents with epilepsy.

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Section: Pharmacokinetics and Drug Interactionsmentioning

confidence: 99%

Section: Pharmacokinetics and Drug Interactionsmentioning

confidence: 99%

Section: Safety Profilementioning

confidence: 99%

Section: Safety Profilementioning

confidence: 99%

See 2 more Smart Citations

Current role of perampanel in pediatric epilepsy

et al. 2017

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“…Нежелательные явления описаны у 19 (30,6 %) пациентов и привели к отмене перампанела в 4 (6,5 %) случаях. Частые нежелательные явления включали поведенческие нарушения (возбуждение, агрессивность), сонливость, вялость [13].…”

Section: Ch I Ld Neurology R U S S I a N J O U R N A L O Funclassified

Perampanel in the treatment of drug-resistant epilepsy in children

Бобылова¹,

Мухин²

2017

Rus. ž. det. nevrol.

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Efficacy and safety of perampanel monotherapy in Chinese patients with focal‐onset seizures: A single‐center, prospective, real‐world observational study

Ma,

Zhu,

Chen

et al. 2023

Epilepsia Open

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ObjectiveEfficacy and safety of perampanel monotherapy for treating focal‐onset seizures (FOS) has been barely studied in China. This observational study aimed to evaluate the efficacy and safety of perampanel monotherapy in treating Chinese patients with FOS.MethodsThis single‐center, prospective, real‐world observational study enrolled patients aged ≥4 years with FOS who visited the Epilepsy Out‐Patient Clinic of Nanjing Brain Hospital affiliated to Nanjing Medical University from January 2020 to December 2021. All patients were treated with perampanel monotherapy. Seizure‐freedom rates after 6 and 12 months of treatment were calculated. Adverse events (AEs) were recorded.ResultsSeventy patients with FOS were enrolled. The mean maintenance perampanel dose was 4.64 ± 1.55 mg/day. The 6‐ and 12‐month retention rates of perampanel monotherapy were 78.6% (55/70) and 70.0% (49/70), respectively. The 6‐ and 12‐month seizure‐freedom rates were 69.84% (44/63) and 65.08% (41/63), respectively. Patients with focal to bilateral tonic–clonic seizures had significantly higher 6‐month and numerically higher 12‐month seizure freedom rates than patients with focal impaired awareness seizures (P = 0.046 and P = 0.204, respectively). Twenty‐six (37.1%) patients experienced treatment‐emergent AEs, and the most common AE was dizziness. Four (5.7%) patients withdrew from the study due to AEs. No new safety concern was observed.SignificanceThis is the first prospective study on the efficacy and safety of perampanel monotherapy in treating Chinese patients with FOS, and perampanel monotherapy was effective and safe in treating Chinese patients aged ≥4 years with FOS up to 12 months. More multicenter, real‐world studies with large sample sizes and longer follow‐ups are needed to further evaluate the long‐term efficacy and safety of perampanel monotherapy.

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Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies—An Italian observational multicenter study

Cited by 65 publications

References 16 publications

Current role of perampanel in pediatric epilepsy

Current role of perampanel in pediatric epilepsy

Perampanel in the treatment of drug-resistant epilepsy in children

Efficacy and safety of perampanel monotherapy in Chinese patients with focal‐onset seizures: A single‐center, prospective, real‐world observational study

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