Evaluating the safety of Fycompa injection for seizures
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)
Run by Eisai Inc. · NCT06657378 · Data updated 2026-11-12
This study is testing the safety of a new injection called Fycompa for people with epilepsy who have certain types of seizures.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 4 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Eisai Inc. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Status | Recruiting |
| Started | November 18, 2024 |
| Main results expected | June 15, 2028 |
| Study ends | June 15, 2028 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT06657378 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 4 years and older with partial-onset seizures or those aged 12 years and older with primary generalized tonic-clonic seizures who are receiving Fycompa for the first time.
✕Probably not a fit
Patients who have previously received Fycompa injection or those with other types of seizures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety of Fycompa injection in individuals with epilepsy, specifically those experiencing partial-onset seizures or primary generalized tonic-clonic seizures. Participants aged 4 years and older with partial-onset seizures and those aged 12 years and older with tonic-clonic seizures will be included. The study is observational and focuses on patients receiving Fycompa for the first time, without specific exclusion criteria, reflecting real-world clinical practice.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data for Fycompa injection, potentially improving treatment options for patients with epilepsy.
How similar studies have gone: While this study focuses on the safety of Fycompa, similar studies evaluating the safety of other epilepsy treatments have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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1
Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Eisai Inquiry Service
- Email: eisai-chiken_hotline@hhc.eisai.co.jp
- Phone: 0120-419-497
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.