Back to results4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Perampanel
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Refractory, Partial, Seizures
Eligibility Criteria
KEY INCLUSION CRITERIA: Have completed all scheduled visits up to and including Visit 8 in the E2007-A001-206 (NCT00144690) study or Visit 9 of the E2007-G000-208 (NCT00416195) study. Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events. Females of childbearing potential must continue practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or Intrauterine device (IUD)) and for 8 weeks after the end of the OLE study. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (e.g., a barrier method plus spermicide, or IUD). Are between the ages of 18 and 70 years of age, inclusive. Are at least 40 kg (88 lb) of weight. Are currently being treated with a stable dose of one, or a maximum of three licensed Anti-epileptic drugs (AEDs) and are known to take their medication(s) as directed. KEY EXCLUSION CRITERIA: Show evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.,) that, in the opinion of the Investigator(s), could affect the participant's safety or trial conduct. Show evidence of significant active hepatic disease and/or bilirubin greater than 1.5 mg/dL. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than two times the upper limit of normal (ULN). Show evidence of significant active hematological disease. White blood cell (WBC) count cannot be less than or equal to 2500/microL or an absolute neutrophil count less than or equal to 1000/microL. Clinically significant ECG abnormality, including prolonged QTc (defined as greater than or equal to 450 msec). Presence of major active psychiatric disease. Participants taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perampanel
Arm Description
Participants previously receiving placebo/perampanel in the double blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily during the OLE study
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The data is presented in the safety section of the results.
Secondary Outcome Measures
Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00368472
Brief Title
4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
Official Title
An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study of E2007 (Perampanel) as an Adjunctive Therapy in Patients With Refractory Partial Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.
Detailed Description
This is an Open-Label Extension (OLE) study for patients who completed the E2007-A001-206 (NCT00144690) or the E2007-G000-208 (NCT00416195) double-blind, placebo-controlled, dose-escalation, parallel-group studies.
This study consisted of 3 periods: OLE Titration (12 weeks), OLE Maintenance (424 weeks), and OLE Follow-up (4 weeks). During the OLE Titration Period, participants were titrated to their maximum tolerated dose (MTD) of perampanel, up to a maximum of 12 mg/day. The OLE Maintenance Period began at completion of the OLE Titration Period; participants remained on the dose achieved at the end of the OLE Titration Period unless dose adjustment for tolerability reasons was necessary. Participants who either withdrew from the study prematurely or completed the OLE Maintenance Period returned for a final visit at the end of the 4-week OLE Follow-up Period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Refractory, Partial, Seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perampanel
Arm Type
Experimental
Arm Description
Participants previously receiving placebo/perampanel in the double blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily during the OLE study
Intervention Type
Drug
Intervention Name(s)
Perampanel
Intervention Description
Perampanel 2 mg to 12 mg, once daily during the OLE study
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
Description
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The data is presented in the safety section of the results.
Time Frame
From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years
Secondary Outcome Measure Information:
Title
Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline
Description
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.
Time Frame
Baseline up to Week 221
Title
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline
Description
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.
Time Frame
Baseline up to week 221
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
KEY INCLUSION CRITERIA:
Have completed all scheduled visits up to and including Visit 8 in the E2007-A001-206 (NCT00144690) study or Visit 9 of the E2007-G000-208 (NCT00416195) study.
Are reliable and willing to make themselves available for the study period and are able to record seizures and report adverse events themselves or have a caregiver who can record and report the events.
Females of childbearing potential must continue practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or Intrauterine device (IUD)) and for 8 weeks after the end of the OLE study. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (e.g., a barrier method plus spermicide, or IUD).
Are between the ages of 18 and 70 years of age, inclusive.
Are at least 40 kg (88 lb) of weight.
Are currently being treated with a stable dose of one, or a maximum of three licensed Anti-epileptic drugs (AEDs) and are known to take their medication(s) as directed.
KEY EXCLUSION CRITERIA:
Show evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.,) that, in the opinion of the Investigator(s), could affect the participant's safety or trial conduct.
Show evidence of significant active hepatic disease and/or bilirubin greater than 1.5 mg/dL. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than two times the upper limit of normal (ULN).
Show evidence of significant active hematological disease. White blood cell (WBC) count cannot be less than or equal to 2500/microL or an absolute neutrophil count less than or equal to 1000/microL.
Clinically significant ECG abnormality, including prolonged QTc (defined as greater than or equal to 450 msec).
Presence of major active psychiatric disease. Participants taking a stable dose of selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed.
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
City
Tielt
ZIP/Postal Code
B-8700
Country
Belgium
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czech Republic
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
City
Tartu
ZIP/Postal Code
EE-51014
Country
Estonia
City
Kuopio
ZIP/Postal Code
FI-70210
Country
Finland
City
Tampere
ZIP/Postal Code
FI-33520
Country
Finland
City
Lille
ZIP/Postal Code
59037
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Ramonville Saint-Agne
ZIP/Postal Code
31520
Country
France
City
Berlin
ZIP/Postal Code
D-10365
Country
Germany
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
City
Munchen
ZIP/Postal Code
80333
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
City
Kaunas
ZIP/Postal Code
LT-50185
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-03215
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
Rotterdam
ZIP/Postal Code
3012 KM
Country
Netherlands
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Stockholm
ZIP/Postal Code
112 45
Country
Sweden
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35305920
Citation
Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.
Results Reference
derived
PubMed Identifier
22913800
Citation
Rektor I, Krauss GL, Bar M, Biton V, Klapper JA, Vaiciene-Magistris N, Kuba R, Squillacote D, Gee M, Kumar D. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurol Scand. 2012 Oct;126(4):263-9. doi: 10.1111/ane.12001. Epub 2012 Aug 23.
Results Reference
derived
Learn more about this trial
4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
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