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Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
perampanel
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Partial onset seizures

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Each participant who met the following criteria were enrolled in this study:

  1. Who completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and complied with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
  2. Provided written informed consent signed by participant or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent was provided by the legal guardian because the participant was unable to do so, a written or verbal assent from the participant was obtained).
  3. Who was considered reliable and willing to be available for the study period and record seizures and report adverse events them self or have a caregiver who can record and report the events for them.
  4. Females who were either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. Females of childbearing potential were enrolled only if they agreed to be abstinent or continue using at least 1 medically acceptable method of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the study period and for 2 months after the last dose of study drug. Women using hormonal contraceptives were required to use an additional approved method of contraception (as described previously) continuously throughout the entire study period and for 2 months after the last dose of study drug. (It was not required for male subjects to use contraceptive measures based on preclinical toxicology data).
  5. Continued to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs.

Exclusion Criteria:

Participants who met the following criteria were excluded from the study:

1. Those who, for any reason, discontinued early from the preceding double-blind study.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perampanel

Arm Description

Participants previously receiving perampanel/placebo in the double blind-study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years.

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 with 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.

Secondary Outcome Measures

Median 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 pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.
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. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.

Full Information

First Posted
August 13, 2008
Last Updated
February 11, 2016
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00735397
Brief Title
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Official Title
An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.
Detailed Description
This was an open-label extension (OLE) study for subjects who completed one of the following double-blind, placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), and E2007-G000-306 (NCT00700310). This OLE study consisted of 2 phases: an Open-label Treatment Phase (comprised of a 16-week blinded Conversion Period and a 256-week Maintenance Period) and a Follow-up Phase (4 weeks). During the Conversion Period, subjects and investigators remained blinded to the treatment received in the previous DB study. To achieve this, all subjects continued to take 6 tablets of study medication (2 mg perampanel or matching placebo) or fewer as they were instructed during the core Double-Blind (DB) study. During the open-label Maintenance Period, subjects were treated with the perampanel dose that provided the best combination of individual efficacy and tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Partial onset seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perampanel
Arm Type
Experimental
Arm Description
Participants previously receiving perampanel/placebo in the double blind-study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years.
Intervention Type
Drug
Intervention Name(s)
perampanel
Intervention Description
Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years
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 with 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.
Time Frame
From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.
Secondary Outcome Measure Information:
Title
Median 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 pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.
Time Frame
Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)
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. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.
Time Frame
Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Each participant who met the following criteria were enrolled in this study: Who completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and complied with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences). Provided written informed consent signed by participant or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent was provided by the legal guardian because the participant was unable to do so, a written or verbal assent from the participant was obtained). Who was considered reliable and willing to be available for the study period and record seizures and report adverse events them self or have a caregiver who can record and report the events for them. Females who were either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. Females of childbearing potential were enrolled only if they agreed to be abstinent or continue using at least 1 medically acceptable method of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the study period and for 2 months after the last dose of study drug. Women using hormonal contraceptives were required to use an additional approved method of contraception (as described previously) continuously throughout the entire study period and for 2 months after the last dose of study drug. (It was not required for male subjects to use contraceptive measures based on preclinical toxicology data). Continued to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs. Exclusion Criteria: Participants who met the following criteria were excluded from the study: 1. Those who, for any reason, discontinued early from the preceding double-blind study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Gee, PhD.
Organizational Affiliation
Eisai Limited
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
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United States
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Little Rock
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Arkansas
ZIP/Postal Code
72205
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United States
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Fresno
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California
ZIP/Postal Code
93710
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United States
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San Francisco
State/Province
California
ZIP/Postal Code
94115
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United States
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Ventura
State/Province
California
ZIP/Postal Code
93003
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United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
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United States
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
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Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
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United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
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Atlanta
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Georgia
ZIP/Postal Code
30342
Country
United States
City
Suwanee
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Georgia
ZIP/Postal Code
30024
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United States
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Boise
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Idaho
ZIP/Postal Code
83702
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United States
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Indianapolis
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Indiana
ZIP/Postal Code
46256
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United States
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Ames
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Iowa
ZIP/Postal Code
50010
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United States
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Lexington
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Kentucky
ZIP/Postal Code
40536
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United States
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Houma
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Louisiana
ZIP/Postal Code
70363
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21287-7247
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United States
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Bethesda
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Maryland
ZIP/Postal Code
20817
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Hattiesburg
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Mississippi
ZIP/Postal Code
39401
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United States
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Chesterfield
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Missouri
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63017
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United States
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Kansas City
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Missouri
ZIP/Postal Code
64111
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United States
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Saint Louis
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Missouri
ZIP/Postal Code
63110
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United States
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Albany
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New York
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12208
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United States
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Buffalo
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New York
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14222
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United States
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Great Neck
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New York
ZIP/Postal Code
11021
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United States
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Lawrence
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New York
ZIP/Postal Code
11559
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United States
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New York
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New York
ZIP/Postal Code
10016
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United States
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Rochester
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New York
ZIP/Postal Code
14642
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United States
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Syracuse
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New York
ZIP/Postal Code
13210
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United States
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Asheville
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North Carolina
ZIP/Postal Code
28806
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United States
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Akron
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Ohio
ZIP/Postal Code
44308
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United States
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Cincinnati
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Ohio
ZIP/Postal Code
45219
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United States
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Columbus
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Ohio
ZIP/Postal Code
43221
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United States
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Toledo
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Ohio
ZIP/Postal Code
43614
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Tulsa
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Oklahoma
ZIP/Postal Code
74137
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Portland
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Oregon
ZIP/Postal Code
97210
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Philadelphia
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Pennsylvania
ZIP/Postal Code
19104
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United States
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Philadelphia
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Pennsylvania
ZIP/Postal Code
19107
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United States
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Charleston
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South Carolina
ZIP/Postal Code
29425
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United States
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Memphis
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Tennessee
ZIP/Postal Code
38105
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United States
City
Dallas
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Texas
ZIP/Postal Code
75230
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United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
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United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
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United States
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
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United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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United States
City
Salt Lake City
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Utah
ZIP/Postal Code
84108
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United States
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Richmond
State/Province
Virginia
ZIP/Postal Code
23298
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United States
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Seattle
State/Province
Washington
ZIP/Postal Code
98104
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United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
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United States
City
Buenos Aires
ZIP/Postal Code
C1406FWY
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Argentina
City
Capital Federal
ZIP/Postal Code
1428
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Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1117ABE
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1182ACD
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
City
Cordoba
ZIP/Postal Code
X5000JJS
Country
Argentina
City
Cordoba
ZIP/Postal Code
X5010AOC
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Argentina
City
Guaymallen
ZIP/Postal Code
M5519FNF
Country
Argentina
City
La Plata, Buenos Aires
ZIP/Postal Code
B1902AHD
Country
Argentina
City
Lanus Oeste, Buenos Aires
ZIP/Postal Code
B1824CWE
Country
Argentina
City
Rosario
ZIP/Postal Code
S2000DSV
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Argentina
City
Salta
ZIP/Postal Code
A4402AYT
Country
Argentina
City
Tucuman
ZIP/Postal Code
T4000DVD
Country
Argentina
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
A-4021
Country
Austria
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
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Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1T9
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Canada
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
City
Santiago
ZIP/Postal Code
3459
Country
Chile
City
Santiago
ZIP/Postal Code
8260094
Country
Chile
City
Santiago
ZIP/Postal Code
8900085
Country
Chile
City
Valdivia
ZIP/Postal Code
5090145
Country
Chile
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Chengdu
ZIP/Postal Code
610041
Country
China
City
Chongqing
ZIP/Postal Code
400016
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Praha 4
ZIP/Postal Code
140 59
Country
Czech Republic
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
City
Tallinn
ZIP/Postal Code
EE-13419
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
Bethune
ZIP/Postal Code
62408
Country
France
City
Bron
ZIP/Postal Code
69677
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Bernau
ZIP/Postal Code
16321
Country
Germany
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Dusseldorf
ZIP/Postal Code
40212
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
City
Kehl-Kork
ZIP/Postal Code
77694
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Marburg
ZIP/Postal Code
35039
Country
Germany
City
Munchen
ZIP/Postal Code
81377
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
City
Hong Kong
Country
Hong Kong
City
Kowloon
Country
Hong Kong
City
Pokfulam
ZIP/Postal Code
852
Country
Hong Kong
City
Shatin
Country
Hong Kong
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1143
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Hyderabad
ZIP/Postal Code
500001
Country
India
City
Hyderabad
ZIP/Postal Code
500082
Country
India
City
Jaipur
ZIP/Postal Code
302004
Country
India
City
Mangalore
ZIP/Postal Code
575002
Country
India
City
Mumbai
ZIP/Postal Code
400026
Country
India
City
Nagpur
ZIP/Postal Code
440010
Country
India
City
Nasik
ZIP/Postal Code
422004
Country
India
City
New Delhi
ZIP/Postal Code
110060
Country
India
City
Pune
ZIP/Postal Code
411011
Country
India
City
Pune
ZIP/Postal Code
411030
Country
India
City
Visakhapatnam
ZIP/Postal Code
530002
Country
India
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Holon
ZIP/Postal Code
58100
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Firenze
ZIP/Postal Code
50134
Country
Italy
City
Genova
ZIP/Postal Code
16147
Country
Italy
City
Milano
ZIP/Postal Code
20121
Country
Italy
City
Milano
ZIP/Postal Code
20133
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Busan
ZIP/Postal Code
614735
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
700712
Country
Korea, Republic of
City
Pusan
ZIP/Postal Code
602715
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138736
Country
Korea, Republic of
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
City
Kuala Terengganu
ZIP/Postal Code
20400
Country
Malaysia
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
City
Mexico City, Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
City
Monterrey, Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
City
Heeze
ZIP/Postal Code
5591 VE
Country
Netherlands
City
Zwolle
ZIP/Postal Code
8025 BV
Country
Netherlands
City
Ermita
ZIP/Postal Code
1000
Country
Philippines
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
City
Bucharest
ZIP/Postal Code
20125
Country
Romania
City
Bucharest
Country
Romania
City
Ekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
City
Moscow
ZIP/Postal Code
107066
Country
Russian Federation
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125412
Country
Russian Federation
City
Nizhniy Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
City
Omsk
ZIP/Postal Code
644001
Country
Russian Federation
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
City
Tyumen
ZIP/Postal Code
625039
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Nis
ZIP/Postal Code
18000
Country
Serbia
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18012
Country
Spain
City
Badalona
State/Province
Cataluna
ZIP/Postal Code
8916
Country
Spain
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
8003
Country
Spain
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
8025
Country
Spain
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46009
Country
Spain
City
Alcorcon
State/Province
Madrid, Communidad de
ZIP/Postal Code
28922
Country
Spain
City
Madrid
State/Province
Madrid, Communidad de
ZIP/Postal Code
28040
Country
Spain
City
Baracaldo
State/Province
Pais Vasco
ZIP/Postal Code
48903
Country
Spain
City
Goteborg
Country
Sweden
City
Linkoping
Country
Sweden
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
City
Muang
ZIP/Postal Code
40002
Country
Thailand
City
Donetsk
ZIP/Postal Code
83052
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
City
Kyiv
ZIP/Postal Code
4080
Country
Ukraine
City
Kyiv
ZIP/Postal Code
4209
Country
Ukraine
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Stoke-on-Trent
ZIP/Postal Code
ST4 7LN
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
29574701
Citation
Krauss GL, Perucca E, Kwan P, Ben-Menachem E, Wang XF, Shih JJ, Patten A, Yang H, Williams B, Laurenza A. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase III randomized trials: Study 307. Epilepsia. 2018 Apr;59(4):866-876. doi: 10.1111/epi.14044. Epub 2018 Mar 25.
Results Reference
derived
PubMed Identifier
25823975
Citation
Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.
Results Reference
derived
PubMed Identifier
24867391
Citation
Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Clement JF, Wang X, Bagul M, Gee M, Zhu J, Squillacote D. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalized seizures: results from phase III extension study 307. Epilepsia. 2014 Jul;55(7):1058-68. doi: 10.1111/epi.12643. Epub 2014 May 27.
Results Reference
derived

Learn more about this trial

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

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