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

Completed

• Conditions: Partial-onset Seizures; Epilepsy
• Interventions: Drug: Perampanel

• Registration Number: NCT04230044
• Lead Sponsor: Eisai Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-11
• Primary Completion: 2017-07-03
• Study Completion: 2017-07-03
• Status Verified: 2019-11
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-13
• Last Update Submitted: 2020-01-13
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fycompa® (perampanel)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	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 Outcome Measures

Name	Time	Method
Response Rate	Baseline, Week 12, Week 24 and Week 52	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.
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	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.