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

February 11, 2016 updated by: Eisai Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Argentina
      • Buenos Aires, Argentina, C1406FWY
      • Capital Federal, Argentina, 1428
      • Ciudad Autonoma de Buenos Aires, Argentina, C1280AEB
      • Ciudad Autonoma de Buenos Aires, Argentina, C1117ABE
      • Ciudad Autonoma de Buenos Aires, Argentina, C1122AAK
      • Ciudad Autonoma de Buenos Aires, Argentina, C1182ACD
      • Ciudad Autonoma de Buenos Aires, Argentina, C1221ADC
      • Cordoba, Argentina, X5000JJS
      • Cordoba, Argentina, X5010AOC
      • Guaymallen, Argentina, M5519FNF
      • La Plata, Buenos Aires, Argentina, B1902AHD
      • Lanus Oeste, Buenos Aires, Argentina, B1824CWE
      • Rosario, Argentina, S2000DSV
      • Salta, Argentina, A4402AYT
      • Tucuman, Argentina, T4000DVD
  • Australia
    • South Australia
      • Woodville, South Australia, Australia, 5011
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
      • Heidelberg, Victoria, Australia, 3084
      • Parkville, Victoria, Australia, 3050
  • Austria
      • Graz, Austria, 8036
      • Innsbruck, Austria, 6020
      • Linz, Austria, A-4021
  • Belgium
      • Bruxelles, Belgium, 1070
      • Leuven, Belgium, 3000
      • Ottignies, Belgium, 1340
  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Plovdiv, Bulgaria, 4002
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1113
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Toronto, Ontario, Canada, M5B 1T9
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
  • Chile
      • Santiago, Chile, 8900085
      • Santiago, Chile, 3459
      • Santiago, Chile, 8260094
      • Valdivia, Chile, 5090145
  • China
      • Beijing, China, 100730
      • Chengdu, China, 610041
      • Chongqing, China, 400016
      • Shanghai, China, 200040
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
      • Praha 4, Czech Republic, 140 59
      • Praha 5, Czech Republic, 150 06
  • Estonia
      • Tallinn, Estonia, EE-13419
      • Tartu, Estonia, EE-51014
  • Finland
      • Kuopio, Finland, FI-70210
      • Tampere, Finland, FI-33520
  • France
      • Bethune, France, 62408
      • Bron, France, 69677
      • Montpellier, France, 34295
      • Rennes, France, 35033
      • Toulouse, France, 31059
  • Germany
      • Berlin, Germany, 10117
      • Bernau, Germany, 16321
      • Bielefeld, Germany, 33617
      • Bonn, Germany, 53127
      • Dusseldorf, Germany, 40212
      • Erlangen, Germany, 91054
      • Gottingen, Germany, 37075
      • Kehl-Kork, Germany, 77694
      • Mainz, Germany, 55131
      • Marburg, Germany, 35039
      • Munchen, Germany, 81377
      • Ulm, Germany, 89081
      • Westerstede, Germany, 26655
  • Greece
      • Thessaloniki, Greece, 546 36
      • Thessaloniki, Greece, 57010
  • Hong Kong
      • Hong Kong, Hong Kong
      • Kowloon, Hong Kong
      • Pokfulam, Hong Kong, 852
      • Shatin, Hong Kong
  • Hungary
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1097
      • Budapest, Hungary, 1136
      • Budapest, Hungary, H-1143
      • Kecskemet, Hungary, 6000
  • India
      • Hyderabad, India, 500082
      • Hyderabad, India, 500001
      • Jaipur, India, 302004
      • Mangalore, India, 575002
      • Mumbai, India, 400026
      • Nagpur, India, 440010
      • Nasik, India, 422004
      • New Delhi, India, 110060
      • Pune, India, 411030
      • Pune, India, 411011
      • Visakhapatnam, India, 530002
  • Israel
      • Ashkelon, Israel, 78278
      • Haifa, Israel, 31096
      • Holon, Israel, 58100
      • Kfar Saba, Israel, 44281
      • Petach Tikva, Israel, 49202
      • Ramat Gan, Israel, 52621
  • Italy
      • Firenze, Italy, 50134
      • Genova, Italy, 16147
      • Milano, Italy, 20133
      • Milano, Italy, 20121
      • Napoli, Italy, 80131
  • Korea, Republic of
      • Busan, Korea, Republic of, 614735
      • Daegu, Korea, Republic of, 700712
      • Pusan, Korea, Republic of, 602715
      • Seoul, Korea, Republic of, 110744
      • Seoul, Korea, Republic of, 138736
      • Seoul, Korea, Republic of, 135710
      • Seoul, Korea, Republic of, 120752
  • Latvia
      • Riga, Latvia, LV-1038
      • Riga, Latvia, LV-1004
      • Valmiera, Latvia, LV-4201
  • Lithuania
      • Kaunas, Lithuania, LT-50009
      • Klaipeda, Lithuania, LT-92288
      • Vilnius, Lithuania, LT-08661
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
      • Kuala Terengganu, Malaysia, 20400
  • Mexico
      • Aguascalientes, Mexico, 20127
      • Mexico City, Distrito Federal, Mexico, 14050
      • Monterrey, Nuevo Leon, Mexico, 64000
      • San Luis Potosi, Mexico, 78240
  • Netherlands
      • Heeze, Netherlands, 5591 VE
      • Zwolle, Netherlands, 8025 BV
  • Philippines
      • Ermita, Philippines, 1000
      • Makati City, Philippines, 1229
  • Poland
      • Bialystok, Poland, 15-276
      • Gdansk, Poland, 80-803
      • Gdansk, Poland, 80-952
      • Katowice, Poland, 40-635
      • Lublin, Poland, 20-718
      • Warszawa, Poland, 02-957
  • Portugal
      • Coimbra, Portugal, 3000-075
      • Lisboa, Portugal, 1649-035
      • Porto, Portugal, 4200-319
  • Romania
      • Bucharest, Romania
      • Bucharest, Romania, 20125
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620149
      • Kazan, Russian Federation, 420097
      • Moscow, Russian Federation, 119992
      • Moscow, Russian Federation, 107076
      • Moscow, Russian Federation, 107066
      • Moscow, Russian Federation, 125412
      • Nizhniy Novgorod, Russian Federation, 603005
      • Omsk, Russian Federation, 644001
      • Samara, Russian Federation, 443095
      • Smolensk, Russian Federation, 214018
      • Tyumen, Russian Federation, 625039
      • Yaroslavl, Russian Federation, 150030
  • Serbia
      • Belgrade, Serbia, 11000
      • Nis, Serbia, 18000
      • Novi Sad, Serbia, 21000
  • South Africa
      • Cape Town, South Africa, 7500
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2196
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
  • Spain
    • Andalucia
      • Granada, Andalucia, Spain, 18012
    • Cataluna
      • Badalona, Cataluna, Spain, 8916
      • Barcelona, Cataluna, Spain, 8003
      • Barcelona, Cataluna, Spain, 8025
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46009
    • Madrid, Communidad de
      • Alcorcon, Madrid, Communidad de, Spain, 28922
      • Madrid, Madrid, Communidad de, Spain, 28040
    • Pais Vasco
      • Baracaldo, Pais Vasco, Spain, 48903
  • Sweden
      • Goteborg, Sweden
      • Linkoping, Sweden
  • Taiwan
      • Kaohsiung, Taiwan, 833
      • Taichung, Taiwan, 40705
      • Tainan, Taiwan, 70403
      • Taoyuan, Taiwan, 333
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Bangkok, Thailand, 10330
      • Chiangmai, Thailand, 50200
      • Muang, Thailand, 40002
  • Ukraine
      • Donetsk, Ukraine, 83114
      • Donetsk, Ukraine, 83052
      • Kharkiv, Ukraine, 61068
      • Kharkiv, Ukraine, 61018
      • Kyiv, Ukraine, 4209
      • Kyiv, Ukraine, 4080
      • Lviv, Ukraine, 79010
      • Uzhgorod, Ukraine, 88000
  • United Kingdom
      • Liverpool, United Kingdom, L9 7LJ
      • London, United Kingdom, SW17 0QT
      • Middlesbrough, United Kingdom, TS4 3BW
      • Stoke-on-Trent, United Kingdom, ST4 7LN
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Phoenix, Arizona, United States, 85004
      • Tucson, Arizona, United States, 85724
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Fresno, California, United States, 93710
      • San Francisco, California, United States, 94115
      • Ventura, California, United States, 93003
    • Colorado
      • Denver, Colorado, United States, 80218
      • Fort Collins, Colorado, United States, 80525
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gulf Breeze, Florida, United States, 32561
      • Jacksonville, Florida, United States, 32209
      • Jacksonville, Florida, United States, 32224
      • Orlando, Florida, United States, 32819
      • Tallahassee, Florida, United States, 32308
      • Tampa, Florida, United States, 33609
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Suwanee, Georgia, United States, 30024
    • Idaho
      • Boise, Idaho, United States, 83702
    • Indiana
      • Indianapolis, Indiana, United States, 46256
    • Iowa
      • Ames, Iowa, United States, 50010
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Louisiana
      • Houma, Louisiana, United States, 70363
    • Maryland
      • Baltimore, Maryland, United States, 21287-7247
      • Bethesda, Maryland, United States, 20817
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
    • Missouri
      • Chesterfield, Missouri, United States, 63017
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63110
    • New York
      • Albany, New York, United States, 12208
      • Buffalo, New York, United States, 14222
      • Great Neck, New York, United States, 11021
      • Lawrence, New York, United States, 11559
      • New York, New York, United States, 10016
      • Rochester, New York, United States, 14642
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Asheville, North Carolina, United States, 28806
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45219
      • Columbus, Ohio, United States, 43221
      • Toledo, Ohio, United States, 43614
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Memphis, Tennessee, United States, 38105
    • Texas
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75235
      • Dallas, Texas, United States, 75251
      • El Paso, Texas, United States, 79905
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Virginia
      • Richmond, Virginia, United States, 23298
    • Washington
      • Seattle, Washington, United States, 98104
    • Wisconsin
      • Madison, Wisconsin, United States, 53715

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Perampanel
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.
Drug: perampanel
Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)
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.
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.
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)
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.
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)
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michelle Gee, PhD., Eisai Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E2007-G000-307

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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