Skip to content

A single-center, prospective, observational real-world study of Perampanel treatment in children aged 4-18 with epilepsy

A single-center, prospective, observational real-world study of Perampanel treatment in children aged 4-18 with epilepsy

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076947
Enrollment
Unknown
Registered
2023-10-25
Start date
2023-10-25
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

perampanel treatment group:NA

Sponsors

Department of Pediatrics, the First Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 18 Years

Inclusion criteria

Inclusion criteria: ?Clinical symptoms and diagnosis in accordance with the 2017 International League Against Epilepsy (ILAE) diagnostic criteria for focal onset epilepsy;?Age between 4 and 18 years;?Receipt of treatment with Perampanel;?Informed consent from the legal guardians of pediatric patients, who are willing to actively participate in the treatment and undergo a follow-up period of at least six months.

Exclusion criteria

Exclusion criteria: ?Poor adherence to the treatment regimen, including inconsistent medication usage, self-adjustment of medication dosage, self-discontinuation of treatment, refusal to undergo regular check-ups, and non-cooperation with follow-up assessments. ?Participants with a follow-up period of less than six months. ?Involvement in concurrent participation in other clinical trials. ?Participants with inaccurate or unreliable clinical records.

Design outcomes

Primary

MeasureTime frame
During treatment visits, Proportion of subjects with =50% reduction in seizure frequency from baseline at different time points;

Secondary

MeasureTime frame
Adverse event incidence rate;Drug retention rate at different time points;During treatment visits, Proportion of subjects with seizure-free at different time points;During treatment visits,cognitive improvement at different time points;During treatment visits,sleep quality at different time points;

Countries

China

Contacts

Public ContactLin Xi

The First Affiliated Hospital of Fujian Medical University

linxicc@126.com+86 133 5820 8623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026