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

NCT05257915 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2022-02-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Beijing Children's Hospital

    lead OTHER

Principal Investigators

  • Fang Fang · Beijing Children's Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-10-31
Completion
2022-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257915 on ClinicalTrials.gov