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

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).

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Key information

Conditions

Partial-onset Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Primary Generalized Tonic-clonic Seizures Seizures Signs and Symptoms

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

1

Tokyo, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)

Time frame: Up to 4 weeks
Number of Participants With ADRs Based on Participant Characteristic

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eisai Inquiry Service

CONTACT

[email protected]

0120-419-497

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Oct 24, 2024
Registry last updated: Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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