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

Recruiting

• Conditions: Partial-Onset Seizures; Primary Generalized Tonic-clonic Seizures

• Registration Number: NCT06657378
• Lead Sponsor: Eisai Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-24
• Study Start: 2024-11-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)	Up to 4 weeks

Trial Locations

Locations (1)

1; 🇯🇵 Tokyo, Japan