Evaluating the safety of Fycompa injection for seizures
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)
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 |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | Eisai Inc. Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT06657378 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have previously received Fycompa injection or those with other types of seizures may not benefit from this study.
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 performed: While this study focuses on the safety of Fycompa, similar studies evaluating the safety of other epilepsy treatments have shown promising results.
Eligibility criteria
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 this trial is running
Tokyo
- 1 — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Eisai Inquiry Service
- Email: eisai-chiken_hotline@hhc.eisai.co.jp
- Phone: 0120-419-497
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.