ClinicalTrials.gg
RecruitingNCT06657378Updated Jul 1, 2026

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

An observational study in Partial-Onset Seizures and Primary Generalized Tonic-clonic Seizures, sponsored by Eisai Co., Ltd.. Recruiting at 1 site in Japan. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Eisai Co., Ltd. · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
4 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Partial-Onset Seizures
  • Primary Generalized Tonic-clonic Seizures

Browse trials for

Keywords

  • Seizures
  • Secondarily Generalized Seizures
  • Fycompa
03

In context

Seizures

766 studies on the registry are indexed under Seizures; 136 are open to participants now.

This study's planned enrollment of 110 is below the median of 140 across 216 observational studies indexed under Seizures.

Browse Seizures studies →

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 152 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • The exclusion criteria will not be specified in particular because this survey will be conducted in daily clinical practice.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fycompa

    Other: No Intervention

Interventions

  • OtherNo Intervention

    This is a non-interventional study.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • 1
    Tokyo, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Jun 2028, 42 months after the start.

Of 27 industry-sponsored observational studies under Seizures, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 39. This study's planned 42 months is above that.

Counting every sponsor, half of 80 studies reached it within 38 months; a quarter within 18 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2024
First posted
Oct 24, 2024
StartActual
Nov 18, 2024
Primary completionEst.
Jun 15, 2028
CompletionEst.
Jun 15, 2028
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06657378
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Oct 24, 2024
Start date
Nov 18, 2024
Primary completion
Jun 15, 2028 (estimated)
Completion
Jun 15, 2028 (estimated)
Last update
Jul 1, 2026

Study contacts

Eisai Inquiry Service
Contact
eisai-chiken_hotline@hhc.eisai.co.jp
0120-419-497

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion