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An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427607
Recruitment Status : Completed
First Posted : April 28, 2015
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Perampanel
Enrollment 7
Recruitment Details  
Pre-assignment Details This study was conducted at 8 centers in Japan during the period of 12 May 2015 to 21 Sep 2016. E2007-J000-341 is an open-label extension of E2007-G000-332.
Arm/Group Title Perampanel
Hide Arm/Group 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.
Period Title: Overall Study
Started 7
Completed 6
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Perampanel
Hide Arm/Group 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.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
Safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
35.3  (19.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
3
  42.9%
Male
4
  57.1%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341.
Arm/Group Title Perampanel
Hide Arm/Group 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.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Non-Serious TEAEs 6
Treatment-related TEAEs 0
Severe TEAEs 0
TEAEs leading to study drug dose adjustment 0
Serious TEAE 0
Time Frame From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months
Adverse Event Reporting Description Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
 
Arm/Group Title Perampanel
Hide Arm/Group 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.
All-Cause Mortality
Perampanel
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Serious Adverse Events
Perampanel
Affected / at Risk (%)
Total   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Perampanel
Affected / at Risk (%)
Total   6/7 (85.71%) 
Infections and infestations   
Nasopharyngitis  1  3/7 (42.86%) 
Influenza  1  1/7 (14.29%) 
Injury, poisoning and procedural complications   
Fall  1  1/7 (14.29%) 
Head injury  1  1/7 (14.29%) 
Humerus fracture  1  1/7 (14.29%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/7 (14.29%) 
Hypercholesterolaemia  1  1/7 (14.29%) 
Hyperuricaemia  1  1/7 (14.29%) 
1
Term from vocabulary, MedDRA 19.0.
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hidetaka Hiramatsu
Organization: Eisai Co., Ltd.
Phone: +81-3-3817-5245
EMail: esi_medinfo@eisai.com
Layout table for additonal information
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT02427607    
Other Study ID Numbers: E2007-J000-341
First Submitted: April 23, 2015
First Posted: April 28, 2015
Results First Submitted: September 19, 2017
Results First Posted: July 2, 2018
Last Update Posted: July 2, 2018