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

NCT ID: NCT06657378

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-18

Study Completion Date

2028-06-15

Brief Summary

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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).

Detailed Description

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Conditions

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Partial-Onset Seizures Primary Generalized Tonic-clonic Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fycompa

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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1

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Eisai Inquiry Service

Role: CONTACT

0120-419-497

Other Identifiers

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E2007-M081-517

Identifier Type: -

Identifier Source: org_study_id

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