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

June 24, 2025 updated by: Eisai Co., Ltd.

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Tokyo, Japan
        • Recruiting
        • 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • The exclusion criteria will not be specified in particular because this survey will be conducted in daily clinical practice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fycompa
Other: No Intervention
This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2024

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2028

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2007-M081-517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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