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

Focal Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05497193
• Other study ID #: 20222126
• Status: Active, not recruiting
• Start date: July 1, 2021
• Est. completion date: October 20, 2023

Study information

• Verified date: August 2022
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: October 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Focal Epilepsy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	XI Jing Hospital	Xi'an	Shan XI

Sponsors (1)

Lead Sponsor	Collaborator
Yang Xinwei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	safety after drug treatment	Common adverse reactions include: dizziness, drowsiness, fatigue, irritability, nausea and falls and weight gain.	one year