A Post Marketing Observational Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Epilepsy Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 117
- Primary Endpoint
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Study Overview
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female participants aged 12 years and older
- •Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures.
- •Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment.
- •Participants who had provided written informed consent
Exclusion Criteria
- •Participants not fit to receive Fycompa® as per the latest prescribing information.
- •Participants who were participating in a clinical trial, at the time of the study.
- •Participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigators could affect the participant's safety or trial conduct.
- •Participants who according to the Investigators would not be able to comply with study procedures.
Arms & Interventions
Fycompa® (perampanel)
Fycompa® (perampanel) (oral tablets) treatment will be initiated at 2 milligram (mg) once daily according to the approved package insert, as an add-on drug in addition to other anti-epileptic drugs (AEDs) as prescribed by physician. The dose will be increased based on clinical response and tolerability (by increments of 2 mg/day to a maintenance dose of 4 to 12 mg/day) and participants will be enrolled and observed prospectively for up to 54 Weeks.
Intervention: Perampanel (Drug)
Outcomes
Primary Outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Time Frame: Up to 54 Weeks
AESI will include medication errors, lack of therapeutic efficacy, overdose, abuse, misuse, occupational exposure, paternal exposure and off label use, pregnancy, and exposure to drug during breast feeding.
Secondary Outcomes
- Response Rate(Baseline, Week 12, Week 24 and Week 52)
- Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52)(Baseline, Week 52)
- Change From Baseline in Clinical Global Impression of Change (CGIC) Scores(Baseline, Week 12, Week 24 and Week 52)