Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-10-20

Brief Summary

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This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed.

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Detailed Description

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This project is a multicenter prospective study. The selected case population was given the oral antiepileptic drug perampanel for 12 months, and the seizure control (complete control, markedly effective, effective, ineffective, worsening), EEG changes (normal, Effective, ineffective), and adverse reactions were analyzed, so as to provide a basis for perampanel monotherapy in children with focal epilepsy.

Conditions

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Focal Epilepsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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perampanel

China's state food and drug administration approved indications for adults and children aged 4 or more focal epileptic hair company or not with secondary comprehensive seizures of epilepsy, adding treatment, in July 2020 to monotherapy without clinical approval, the current domestic perampanel monotherapy clinical effectiveness and safety of focal epilepsy in children have not been reported.

Intervention Type DRUG

Other Intervention Names

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No other interventions currently

Eligibility Criteria

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Inclusion Criteria

(1) Clinical diagnosis of focal epilepsy; (2) Take anti-epileptic drugs as prescribed by your doctor; (3) Epilepsy patients diagnosed with focal epilepsy with or without generalized seizures, and Monitoring for ≥12 months; (4) Newly diagnosed epilepsy patients, or only taking 1-2 other AEDs, without regular antiepileptic treatment, the efficacy is not good, after using perampanel, gradually stop AEDs for 8 weeks. For perampanel monotherapy; (5) the number of seizures ≥ 1 in the first 3 months of enrollment.