A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: Partial-Onset Seizures, Primary Generalized Tonic-clonic Seizures. Basic parameters: from 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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
- Other No Intervention
This is a non-interventional study.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- 1 — Tokyo
Identifiers
NCT: NCT06657378 · E2007-M081-517