NCT05257915

A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

A Real-world Clinical Study to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Beijing Children's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a real-word clinical trial. The purpose of this study is to evaluate the effectiveness and safety of perampanel as an add-on treatment for epileptic seizure. The enrolled subjects were epilepsy patients who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment. The study was a real-world prospective clinical study, and the initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation.

Detailed description

This is a multi-center, prospective, observational study. Subjects who meet all of the inclusion and none of the exclusion criteria will be received perampanel. Baseline seizure counts (frequency) data is collected by subjects or guardian/legally authorized representative, retrospectively. It is expected to enroll 600 patients with epilepsy who are eligible for inclusion enrollment and receiving Perampenal from January 2021 to October 2021. The initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation. The patients were followed up for 6 months and recorded the frequency of seizures and self-assessment of improvement. Safety will be assessed by monitoring and recording of all of AEs and serious adverse events (SAEs), discontinuation during 6 months treatment (patient spontaneous reporting).

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Perampanel	For patients ≥12 years old, the initial dose is 2 mg/d, and according to the clinical response and tolerance of the patient, the dose is increased to the minimum clinically effective dose in increments of 2 mg, and the interval between dose increases is not less than 2 weeks. For patients \<12 years, according to the actual clinical situation, the initial dose and addition plan are judged by the investigator.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-10-31
• Completion: 2022-06-30
• First posted: 2022-02-25
• Last updated: 2022-02-25

Locations

5 sites across 1 country: China