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

NCT04230044 | Completed

• 1 other identifier: E2007-M065-411
• Study Type: observational
• Target: 117
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy; Partial-onset Seizures

Keywords

E2007; Fycompa; Perampanel; Partial onset seizures; Epilepsy; Seizures; Post marketing surveillance

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 54 Weeks

Secondary Outcomes (3)

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

  Baseline, Week 52

• Response Rate

  Baseline, Week 12, Week 24 and Week 52

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

  Baseline, Week 12, Week 24 and Week 52

Study Arms (1)

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.

Drug: Perampanel

Interventions

Perampanel DRUG

Perampanel tablets.

Also known as: Fycompa, E2007

Fycompa® (perampanel)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with epilepsy aged 12 years or older.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: April 11, 2016
• Primary Completion: July 3, 2017
• Study Completion: July 3, 2017
• Last Updated: January 18, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share