A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures

A Multicenter, Postmarketing Observational (Noninterventional) Study to Evaluate the Safety of Fycompa for Injection in Patients With Partial-Onset Seizures (Including Secondarily Generalized Seizures) (Age 4 Years or Older) or Primary Generalized Tonic- Clonic Seizures (Age 12 Years or Older)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06657378

Enrollment

110

Registered

2024-10-24

Start date

2024-11-18

Completion date

2028-06-15

Last updated

2026-07-01

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

Conditions

Partial-Onset Seizures, Primary Generalized Tonic-clonic Seizures

Keywords

Seizures, Secondarily Generalized Seizures, Fycompa

Brief summary

The purpose of this study is to determine the safety of Fycompa for injection after administration in participants with epilepsy (partial-onset seizures \[including secondarily generalized seizures\]) (age 4 years or older) or primary generalized tonic-clonic seizures (age 12 years or older).

Interventions

OTHERNo Intervention

This is a non-interventional study.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with epilepsy who received the Fycompa for injection for the first time will be included.

Exclusion criteria

* The

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)	Up to 4 weeks
Number of Participants With ADRs Based on Participant Characteristic	Up to 4 weeks
Plasma Concentration of Fycompa in Children Aged Greater Than or Equal to (>=) 4 Years and Less than (<) 12 Years	Up to 4 weeks

Countries

Japan

Contacts

CONTACTEisai Inquiry Service

eisai-chiken_hotline@hhc.eisai.co.jp0120-419-497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026