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

ConditionsPartial-Onset SeizuresPrimary Generalized Tonic-clonic Seizures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorEisai Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    This is a non-interventional study.

Treatment groups

110 Participants
are divided into 1 treatment group
Group A: Fycompa1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 4 weeks
2

Number of Participants With ADRs Based on Participant Characteristic

Time frame
Up to 4 weeks
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eisai Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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