- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04230044
A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy
January 13, 2020 updated by: Eisai Co., Ltd.
A Post Marketing Observational Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Epilepsy Patients
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
117
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with epilepsy aged 12 years or older.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Perampanel tablets.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 54 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52)
Time Frame: Baseline, Week 52
|
Baseline, Week 52
|
|
Response Rate
Time Frame: 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.
|
Baseline, Week 12, Week 24 and Week 52
|
Change From Baseline in Clinical Global Impression of Change (CGIC) Scores
Time Frame: 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.
|
Baseline, Week 12, Week 24 and Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 11, 2016
Primary Completion (ACTUAL)
July 3, 2017
Study Completion (ACTUAL)
July 3, 2017
Study Registration Dates
First Submitted
January 13, 2020
First Submitted That Met QC Criteria
January 13, 2020
First Posted (ACTUAL)
January 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2007-M065-411
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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