Back to resultsAn Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Perampanel
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Perampanel
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perampanel
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02427607
Brief Title
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Official Title
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 12, 2015 (Actual)
Primary Completion Date
September 21, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Perampanel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perampanel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Perampanel
Other Intervention Name(s)
Fycompa, E2007
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
Description
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.
Time Frame
From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Matsuyama
State/Province
Ehime
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Inashiki-gun
State/Province
Ibaraki
Country
Japan
City
Uji
State/Province
Kyoto
Country
Japan
City
Sakai
State/Province
Osaka
Country
Japan
City
Matsue
State/Province
Shimane
Country
Japan
City
Nerima-Ku
State/Province
Tokyo
Country
Japan
City
Niigata
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
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