NCT06657378RecruitingNot Applicable
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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Number of Participants With ADRs Based on Participant Characteristic
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 4 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)
Time Frame: Up to 4 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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