A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy

Eisai Co., Ltd.117 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

117

Conditions

Epilepsy Partial-onset Seizures

Interventions

PerampanelDRUG

Perampanel tablets.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female participants aged 12 years and older 2. Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures. 3. Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment. 4. Participants who had provided written informed consent Exclusion Criteria: 1. Participants not fit to receive Fycompa® as per the latest prescribing information. 2. Participants who were participating in a clinical trial, at the time of the study. 3. 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. 4. Participants who according to the Investigators would not be able to comply with study procedures.

Outcomes

Primary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

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.

Time frame: Up to 54 Weeks

Secondary Outcomes

Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52)

Time frame: Baseline, Week 52

Response Rate

Response rate will be defined as number of participants with response defined as more than or equal to (\>=) 50 percent (%) reduction in 28-day seizure frequency from Baseline.

Time frame: Baseline, Week 12, Week 24 and Week 52

Change From Baseline in Clinical Global Impression of Change (CGIC) Scores

The CGIC is an assessment performed by the clinician, evaluating the change in the participant's symptoms over time. Assessment will be implemented based on frequency of seizure, severity of seizures, adverse events, and overall conditions on a 7-point scale with the scores as 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse.

Time frame: Baseline, Week 12, Week 24 and Week 52

Data from ClinicalTrials.gov

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