- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03059381
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures (FYC02T)
August 3, 2022 updated by: Eisai Co., Ltd.
The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:
- unknown adverse drug reactions (ADRs);
- occurrence of ADRs;
- factors that are likely to affect safety and efficacy;
- occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
- occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
519
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Osaka, Japan
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Tokyo, Japan
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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 to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice
Description
Inclusion Criteria:
Epilepsy participants from 12 to 17 years of age with:
- Partial seizures (with or without secondary generalized seizures)
- Primary generalized Tonic-clonic seizures
Exclusion Criteria:
- Participants previously treated with Fycompa
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-treated epilepsy participants
Adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa
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The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer.
The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs.
The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with any serious adverse event
Time Frame: from 0 to 104 weeks
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from 0 to 104 weeks
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Number of participants with any non-serious adverse event
Time Frame: from 0 to 104 weeks
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from 0 to 104 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants experiencing seizures
Time Frame: from 0 to 104 weeks
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from 0 to 104 weeks
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Overall improvement rating in seizure frequency
Time Frame: from 0 to 104 weeks
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from 0 to 104 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
August 1, 2016
Primary Completion (Actual)
March 21, 2021
Study Completion (Actual)
March 21, 2021
Study Registration Dates
First Submitted
February 17, 2017
First Submitted That Met QC Criteria
February 20, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
August 5, 2022
Last Update Submitted That Met QC Criteria
August 3, 2022
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2007-M081-503
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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UCB PharmaCompletedPartial Seizures With or Without Secondary GeneralizationGermany
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University Hospital Schleswig-HolsteinCompletedEpilepsy With Partial Onset Seizures With or Without Secondary GeneralizationGermany
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Clinical Trials on Fycompa
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Mayo ClinicCompletedAmyotrophic Lateral SclerosisUnited States
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Eisai Inc.CompletedPartial Onset Seizures | Primary Generalized Tonic-Clonic Seizures | Secondarily Generalized SeizuresUnited States
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American University of Beirut Medical CenterTerminatedAmyotrophic Lateral SclerosisLebanon
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Chinese University of Hong KongUnknownGeneralized Epilepsy | Focal Epilepsy | Partial Seizures, SimpleHong Kong
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Eisai Inc.Completed
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Seoul National University HospitalCompletedElectroencephalographyKorea, Republic of
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Eisai Korea Inc.Recruiting