NCT06657378

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
26mo left

Started Nov 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Nov 2024Jun 2028

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2028

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

3.6 years

First QC Date

October 23, 2024

Last Update Submit

June 24, 2025

Conditions

Partial-Onset SeizuresPrimary Generalized Tonic-clonic Seizures

Keywords

SeizuresSecondarily Generalized SeizuresFycompa

Outcome Measures

Primary Outcomes (3)

  • Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)

    Up to 4 weeks

  • Number of Participants With ADRs Based on Participant Characteristic

    Up to 4 weeks

  • Plasma Concentration of Fycompa in Children Aged Greater Than or Equal to (>=) 4 Years and Less than (<) 12 Years

    Up to 4 weeks

Study Arms (1)

Fycompa

Other: No Intervention

Interventions

No InterventionOTHER

This is a non-interventional study.

Fycompa

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Eisai Inquiry Service

CONTACT

0120-419-497eisai-chiken_hotline@hhc.eisai.co.jp

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 24, 2024

Study Start

November 18, 2024

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

June 15, 2028

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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

Locations

JP(1)