- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427607
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
September 19, 2017 updated by: Eisai Co., Ltd.
To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy.
This study will be continued until perampanel is commercially available.
Study Overview
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 3
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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Niigata, Japan
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Ehime
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Matsuyama, Ehime, Japan
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Hokkaido
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Sapporo, Hokkaido, Japan
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Ibaraki
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Inashiki-gun, Ibaraki, Japan
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Kyoto
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Uji, Kyoto, Japan
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Osaka
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Sakai, Osaka, Japan
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Shimane
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Matsue, Shimane, Japan
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Tokyo
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Nerima-Ku, 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
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Participants participating in the designated perampanel study as below, and who in the opinion of the investigator continue to benefit from treatment with perampanel Designated perampanel study: E2007-G000-332 (NCT01393743) (with at least 52 weeks of total exposure to perampanel).
- Provide written informed consent/assent signed by participant or legal guardian prior to entering the study or undergoing any study procedures. If the written informed consent is provided by the legal guardian because the participant is unable to do so, a written or verbal assent from the participant must also be obtained.
- Female participants of childbearing potential must agree for the duration of the study and for a period of at least 1 month following the last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (eg, a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide]).
Exclusion Criteria
- Participants residing in countries where perampanel is commercially available with respect to the indication or formulation of the designated perampanel study.
- Female participants who are nursing, pregnant, or planning to become pregnant.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Perampanel
Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578].
Doses of perampanel were allowed to be adjusted based on clinical judgment.
A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study.
The maximum daily dose of perampanel permitted was 12 mg per day.
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Perampanel 2 mg tablets.
Doses of perampanel can be adjusted based on clinical judgment.
A minimum perampanel dose of 2 mg per day is required to continue in the study.
The maximum daily dose of perampanel permitted will be 12 mg per day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
Time Frame: From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months
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Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight.
TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332).
A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2 or higher on treatment.
Treatment-related TEAEs were defined as AEs that were considered by the investigator to be possibly or probably related to study treatment.
SAEs were defined as any untoward medical occurrence that at any dose; resulted in death, disability/incapacity, birth defect, required inpatient hospitalization or prolongation of existing hospitalization, or was life-threatening.
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From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months
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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)
May 12, 2015
Primary Completion (Actual)
September 21, 2016
Study Completion (Actual)
November 9, 2016
Study Registration Dates
First Submitted
April 23, 2015
First Submitted That Met QC Criteria
April 23, 2015
First Posted (Estimate)
April 28, 2015
Study Record Updates
Last Update Posted (Actual)
July 2, 2018
Last Update Submitted That Met QC Criteria
September 19, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2007-J000-341
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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NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
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Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
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University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
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Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
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University Hospital, LilleUnknownFocal Epilepsy | Epilepsy IntractableFrance
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UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
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UCB PharmaCompletedEpilepsy, Tonic-clonic
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Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University and other collaboratorsNot yet recruitingEpilepsy, Drug ResistantChina
Clinical Trials on Perampanel
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Eisai Inc.Completed
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Kimford Jay MeadorEisai Inc.Recruiting
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Eisai Inc.CompletedRefractory Partial SeizuresUnited States, Chile, Brazil, Canada, Mexico, Argentina
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Eisai Inc.CompletedRefractory Partial SeizuresUnited States, France, Germany, Italy, United Kingdom, Belgium, Israel, South Africa, Finland, Russian Federation, Austria, Netherlands, Sweden, India
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Weill Medical College of Cornell UniversityEisai Inc.Completed
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National Taiwan University HospitalCompleted
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University Health Network, TorontoDystonia Study GroupCompletedCervical DystoniaUnited States, Canada
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Hospices Civils de LyonCompleted
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Eisai Inc.CompletedEpilepsyBelgium, France, United States, Czech Republic, Estonia, Latvia, Spain, United Kingdom, Lithuania, Germany, Australia, Finland, Netherlands, Sweden
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Eisai Inc.Completed