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

NCT05497193 | Unknown

• 1 other identifier: 20222126
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Focal Epilepsy

Outcome Measures

Primary Outcomes (3)

• clinical efficacy after drug treatment:

  Epilepsy seizures: the seizure frequency 3 months before treatment is the baseline, and the maintenance period is compared with the baseline. Complete control: no seizures after treatment; markedly effective: seizure frequency reduced by \> 75%; effective: seizure frequency reduced by \> 51%-74 %; Ineffective: frequency reduced by ≤50%, worsening: attack frequency increased by 25%.

  one year

• EEG changes after drug treatment

  EEG changes: (1) normal EEG (2) abnormal EEG: including epileptiform discharge, background rhythm slowing, epileptiform discharge + background rhythm slowing. EEG judgment: (1) normal: the epileptiform discharge disappeared or the background slowing disappeared (2) effective: the epileptiform discharge was reduced or the background slowing was improved (3) invalid: the epileptiform discharge did not change or aggravate after the drug.

  one year

• safety after drug treatment

  Common adverse reactions include: dizziness, drowsiness, fatigue, irritability, nausea and falls and weight gain.

  one year

Interventions

perampanel DRUG

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.

Also known as: No other interventions currently

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the pediatric outpatient department of our hospital

You may qualify if:

• (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.

You may not qualify if:

• (1) syncope (2) Pseudo-seizure(3)transient ischemic attack

Sponsors & Collaborators

• Yang Xinwei: lead

Study Sites (1)

XI Jing Hospital

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

perampanel

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• xinwei yang, doctor

  hospital doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 11, 2022
• Study Start: July 1, 2021
• Primary Completion: March 20, 2023
• Study Completion: October 20, 2023
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

CN (1)