Partial-Onset SeizuresNCT06657378
A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures
An observational study of Partial-Onset Seizures and Primary Generalized Tonic-clonic Seizures, run by Eisai Co., Ltd. at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Partial-Onset Seizures, Primary Generalized Tonic-clonic Seizures
- How many people
- 110 participants
- Where
- 1 siteJapan
- Study dates
- 18 Nov 2024to 15 Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with epilepsy who received the Fycompa for injection for the first time will be included.
Who may be able to join
- Participants with epilepsy who received the Fycompa for injection for the first time will be included.
Who cannot join
- The exclusion criteria will not be specified in particular because this survey will be conducted in daily clinical practice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
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).
- Being tested
- No Intervention
- Keywords
- Seizures, Secondarily Generalized Seizures, Fycompa
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Fycompa | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)
Measured: Up to 4 weeks
Number of Participants With ADRs Based on Participant Characteristic
Measured: Up to 4 weeks
Plasma Concentration of Fycompa in Children Aged Greater Than or Equal to (>=) 4 Years and Less than (<) 12 Years
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start18 Nov 2024
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-Onset SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657378
- Sponsor's protocol ID
- E2007-M081-517
- Status last verified
- Jun 2026
- First submitted
- 23 Oct 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.