Hackensack Meridian Children’s Health Research Finds Perampanel for Treatment of Epilepsy Well-Tolerated in Clinical Setting

Multicenter PROVE Phase IV study shows daily oral doses of perampanel have favorable retention rates for pediatric patients

In a real-world clinical care setting, perampanel showed favorable results for treatment of epilepsy in pediatric patients in the Phase IV PROVE study.

Pediatric epileptologist Eric Segal, M.D., Director of Pediatric Epileptology at Joseph M. Sanzari Children’s Hospital at Hackensack University Medical Center, is the lead author on new pediatric epilepsy research published in Science Direct. Dr. Segal and his colleagues, conducted the Phase IV, multicenter, retrospective study, titled “PROVE—Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Interim Analysis in Pediatric Patients,” showing the retention, dosing, efficacy and safety of once-daily, oral anti-seizure medication perampanel (Fycompa) for pediatric patients with epilepsy.

“Our research shows that daily oral doses of perampanel are well-tolerated and have favorable retention rates for pediatric patients,” Dr. Segal said. “These findings provide real-world insight into the effectiveness and safety of perampanel therapy and can inform shared decision-making discussions between pediatric epileptologists, patients and parents.”

In the United States, perampanel is approved to treat focal seizures in patients who are four years old and older. It is also approved for use in combination with other medications to treat generalized tonic-clonic seizures in patients who are 12 years old and older. This study provided insight into the drug’s effectiveness in real-world clinical application.

Dr. Segal and his colleagues analyzed seizure-frequency data from 329 patients. In this analysis, retention rates were shown to be favorable (>35% at 2 years) following initiation of perampanel during routine clinical care, and generally consistent with those reported during interim analyses of PROVE study data from patients aged <12 years. In addition, efficacy was sustained for up to 2 years.

Additionally, prior PROVE findings were published in the Journal of Child Neurology, showing of 334 patients with epilepsy, 42.5 percent of preadolescent patients and 55.7 adolescent patients remained on perampanel 24 months after initiating treatment.

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