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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00735397
First received: August 13, 2008
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

The purpose of this study is 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.


Condition Intervention Phase
Epilepsy
Drug: perampanel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Primary efficacy will be assessed by seizure counts (using subject's diaries) documenting the percent change in seizure frequency per 28 days. [ Time Frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts between visits. After 16 wks, they will be done every 12 wks w/interim telephone contacts in between. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy measures will evaluate the delayed treatment effect by summarizing previous endpoints over the open-label treatment phase relative to the pre-randomization phase of the double-blind study. [ Time Frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts. After 16 weeks, they will be done every 12 wks w/interim telephone contacts in between. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1443
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2 mg/day perampanel
Drug: perampanel
2 mg/day, oral administration.
Experimental: 2
4 mg/day perampanel
Drug: perampanel
4 mg/day, oral administration.
Experimental: 3
6 mg/day perampanel
Drug: perampanel
6 mg/day, oral administration.
Experimental: 4
8 mg/day perampanel
Drug: perampanel
8 mg/day, oral administration.
Experimental: 5
10 mg/day perampanel
Drug: perampanel
10 mg/day, oral administration.
Experimental: 6
12 mg/day perampanel
Drug: perampanel
12 mg/day, oral administration.
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Subjects will receive matching placebo tablets.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each subject must meet all of the following criteria to be enrolled in this study:

  1. Have completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
  2. Provide written informed consent signed by subject 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 subject is unable to do so, a written or verbal assent from the subject must also be obtained).
  3. Be considered reliable and willing to be available for the study period and able to record seizures and report adverse events them self or have a caregiver who can record and report the events for them.
  4. Females should be either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. For females of childbearing potential, they must agree 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 entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (as described previously) throughout the entire study period and for 2 months after the last dose of study drug. (It is not required for male subjects to use contraceptive measures based on preclinical toxicology data).
  5. Continue to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs.

Exclusion Criteria:

Subjects who meet the following criteria will be excluded from the study:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735397

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
St. Joseph's Hospital Medical Center
Phoenix, Arizona, United States, 85013
Xenoscience
Phoenix, Arizona, United States, 85004
University of Arizona
Tucson, Arizona, United States, 85724
United States, Arkansas
Clinical Trials Inc
Little Rock, Arkansas, United States, 72205
United States, California
Neuro Pain Medical Center
Fresno, California, United States, 93710
California Pacific Medical Center
San Francisco, California, United States, 94115
Neurosearch II, Inc.
Ventura, California, United States, 93003
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
Neurology Associates of Northern Colorado
Fort Collins, Colorado, United States, 80525
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Northwest Florida Clinical Research Group, LLC
Gulf Breeze, Florida, United States, 32561
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
University of Florida Health Science Center-Jacksonville
Jacksonville, Florida, United States, 32209
Pediatric Neurology, P.A.
Orlando, Florida, United States, 32819
Tallahassee Neurological Clinic
Tallahassee, Florida, United States, 32308
Pediatric Epilepsy And Neurology Specialists
Tampa, Florida, United States, 33609
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
Georgia Neurology and Sleep Medicine Associates
Suwanee, Georgia, United States, 30024
United States, Idaho
Consultants in Epilepsy and Neurology PLLC
Boise, Idaho, United States, 83702
United States, Indiana
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States, 46256
United States, Iowa
McFarland Clinic, P.C.
Ames, Iowa, United States, 50010
United States, Kentucky
University of Kentucky Research Foundation
Lexington, Kentucky, United States, 40536
United States, Louisiana
LSU Hospital
Houma, Louisiana, United States, 70363
United States, Maryland
John Hopkins Hospital
Baltimore, Maryland, United States, 21287-7247
Midatlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States, 20817
United States, Mississippi
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
The Comprehensive Epilepsy Care Center for Children and Adults, P.C.
Chesterfield, Missouri, United States, 63017
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Women and Childrens Hospital
Buffalo, New York, United States, 14222
Long Island Jewish Medical Center C/O Brany
Great Neck, New York, United States, 11021
Five Towns Neurology, PC
Lawrence, New York, United States, 11559
NYU Comprehensive Epilepsy Center
New York, New York, United States, 10016
Strong Memorial Hospital
Rochester, New York, United States, 14642
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States, 28806
United States, Ohio
Children's Medical Center Hospital of Akron
Akron, Ohio, United States, 44308
University Neurology
Cincinnati, Ohio, United States, 45219
The Ohio State University
Columbus, Ohio, United States, 43221
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, Oklahoma
Neurological Associates Of Tulsa, Inc.
Tulsa, Oklahoma, United States, 74137
United States, Oregon
Providence St. Vincent's Epilepsy Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee LeBonheur Childrens Medical Center
Memphis, Tennessee, United States, 38105
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Neurological Clinic of Texas
Dallas, Texas, United States, 75251
Dallas Pediatric Neurology Associates
Dallas, Texas, United States, 75230
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
UW Regional Epilepsy Center
Seattle, Washington, United States, 98104
United States, Wisconsin
Dean Foundation For Health, Research And Education
Madison, Wisconsin, United States, 53715
Argentina
Hospital General de Agudos Dr. Teodoro Alvarez
Buenos Aires, Argentina, C1406FWY
Fundacion Para la Lucha Contra las Enfermedades Neurologicas de la Infancia
Capital Federal, Argentina, 1428
Fundacion F.a.i.c.e.p
Ciudad Autonoma de Buenos Aires, Argentina, C1122AAK
Hospital General de Agudos Dr. Jose Maria Ramos Mejia
Ciudad Autonoma de Buenos Aires, Argentina, C1221ADC
Hospital Britanico de Buenos Aires
Ciudad Autonoma de Buenos Aires, Argentina, C1280AEB
Neurologia Infantil Buenos Aires - NIBA
Ciudad Autonoma de Buenos Aires, Argentina, C1182ACD
FACENE
Ciudad Autonoma de Buenos Aires, Argentina, C1117ABE
Centro para el estudio y tratamiento de la epilepsia y sueno
Cordoba, Argentina, X5000JJS
Hospital San Roque
Cordoba, Argentina, X5010AOC
Fundacion Cerebro y Mente
Guaymallen, Argentina, M5519FNF
Hogar de Dia Casa Jesi
La Plata, Buenos Aires, Argentina, B1902AHD
Instituto Ginecologico Buenos Aires IGBA
Lanus Oeste, Buenos Aires, Argentina, B1824CWE
Sanatorio Parque
Rosario, Argentina, S2000DSV
Hospital Privado Santa Clara de Asis
Salta, Argentina, A4402AYT
Centro Regional Integral de Neurociencias
Tucuman, Argentina, T4000DVD
Australia, South Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Austin Health
Heidelberg, Victoria, Australia, 3084
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Austria
Medizinische Universitat Graz
Graz, Austria, 8036
Universitatsklinikum Innsbruck
Innsbruck, Austria, 6020
Konventhospital Krankenhaus der Barmherzigen Bruder Linz
Linz, Austria, A-4021
Belgium
Hopital Erasme
Bruxelles, Belgium, 1070
UZ Leuven
Leuven, Belgium, 3000
Centre Neurologique William Lennox
Ottignies, Belgium, 1340
Bulgaria
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
Pleven, Bulgaria, 5800
University Mulitiprofile Hospital for Active Treatment Sveti Georgi
Plovdiv, Bulgaria, 4002
Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum
Sofia, Bulgaria, 1113
Military Medical Academy - MHAT
Sofia, Bulgaria, 1606
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
London Health Science Center
London, Ontario, Canada, N6A 5A5
Youthdale Treatment Centres
Toronto, Ontario, Canada, M5B 1T9
Canada, Quebec
Neuro Rive-Sud
Greenfield Park, Quebec, Canada, J4V 2J2
Chile
Hospital Barros Luco Trudeau
Santiago, Chile, 8900085
Hospital Dr. Sotero del Rio
Santiago, Chile, 3459
Sociedad Lasso y Bittner Ltda Neuropsicologia
Santiago, Chile, 8260094
Hospital de Valdivia
Valdivia, Chile, 5090145
China
Peking Union Medical College Hospital
Beijing, China, 100730
West China Hospital, Sichuan University
Chengdu, China, 610041
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China, 400016
Huashan Hospital
Shanghai, China, 200040
Czech Republic
Fakultni Nemocnice Olomouc
Olomouc, Czech Republic, 775 20
Thomayerova nemocnice
Praha 4, Czech Republic, 140 59
Fakultni nemocnice v Motole
Praha 5, Czech Republic, 150 06
Estonia
Oy Neurodiagnostika AP
Tallinn, Estonia, EE-13419
Tallinn Children's Hospital
Tallinn, Estonia, EE-13419
Tartu University Hospital
Tartu, Estonia, EE-51014
Finland
Kuopion Yliopistollinen sairaala
Kuopio, Finland, FI-70210
FinnMedi Oy
Tampere, Finland, FI-33520
France
Centre Hospitalier Germon et Gauthier
Bethune, France, 62408
Hopital Femme Mere Enfant
Bron, France, 69677
Hopital Gui de Chauliac
Montpellier, France, 34295
Hopital Pontchaillou
Rennes, France, 35033
Hopital de Rangueil
Toulouse, France, 31059
Germany
Charite - Universitatsmedizin Berlin
Berlin, Germany, 10117
Epilepsieklinik Tabor
Bernau, Germany, 16321
Evangelisches Krankenhaus Bielefeld gGmbH
Bielefeld, Germany, 33617
Universitatsklinikum Bonn
Bonn, Germany, 53127
Neurologische Privatpraxis
Dusseldorf, Germany, 40212
Friedrich-Alexander-Universitat Erlangen Nurnberg
Erlangen, Germany, 91054
Universitat-Georg-August
Gottingen, Germany, 37075
Epilepsiezentrum Kork
Kehl-Kork, Germany, 77694
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Germany, 55131
Universitatsklinikum Giessen und Marburg GmbH
Marburg, Germany, 35039
LMU Klinikum der Universitat
Munchen, Germany, 81377
Universitatsklinikum Ulm
Ulm, Germany, 89081
Gemeinschaftspraxis fur Neurologie und Psychiatrie
Westerstede, Germany, 26655
Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, Greece, 57010
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Greece, 546 36
Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
United Christian Hospital
Kowloon, Hong Kong
Queen Mary Hospital
Pokfulam, Hong Kong, 852
Prince of Wales Hospital
Shatin, Hong Kong
Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
Budapest, Hungary, 1097
Orszagos Idegtudomanyi Intezet
Budapest, Hungary, 1145
Bethesda Gyermekkorhaz
Budapest, Hungary, H-1143
Rajna es Fiai Kft
Budapest, Hungary, 1136
Bacs-Kiskun Megyei Korhaz
Kecskemet, Hungary, 6000
India
Care Hospital
Hyderabad, India, 500001
Nizam's Institute of Medical Sciences
Hyderabad, India, 500082
Sawai Man Singh Hospital
Jaipur, India, 302004
Govind Ballabh Pant Hospital
Jaipur, India, 302004
Mallikatta Neuro Center
Mangalore, India, 575002
Jaslok Hospital and Research Centre
Mumbai, India, 400026
Brain and Mind Research Institute
Nagpur, India, 440010
Curie Manavata Cancer Centre
Nasik, India, 422004
Sir Ganga Ram Hospital
New Delhi, India, 110060
KEM Hospital Research Centre
Pune, India, 411011
Poona Hospital and Research Centre
Pune, India, 411030
King George Hospital
Visakhapatnam, India, 530002
Israel
Barzilai Medical Center
Ashkelon, Israel, 78278
Rambam Health Care Campus
Haifa, Israel, 31096
Edith Wolfson Medical Center
Holon, Israel, 58100
Meir Medical Center
Kfar Saba, Israel, 44281
Schneider Children's Medical Center of Israel
Petach Tikva, Israel, 49202
The Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Italy
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy, 50134
Istituto G. Gaslini Ospedale Pediatrico IRCCS
Genova, Italy, 16147
A.O. Ospedale Fatebenefratelli e Oftalmico
Milano, Italy, 20121
Fondazione I.R.C.C.S. di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milano, Italy, 20133
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy, 80131
Korea, Republic of
Inje University Pusan Paik Hospital
Busan, Korea, Republic of, 614735
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 700712
Dong-A University Medical Center
Pusan, Korea, Republic of, 602715
Seoul National University Hospital
Seoul, Korea, Republic of, 110744
Severance Hospital, Yonsei University Healthcare system
Seoul, Korea, Republic of, 120752
Samsung Medical Center
Seoul, Korea, Republic of, 135710
Asan Medical Center
Seoul, Korea, Republic of, 138736
Latvia
Riga Eastern Clinical University Hospital, Clinic Gailezers
Riga, Latvia, LV-1038
Childrens University Hospital
Riga, Latvia, LV-1004
Outpatient Clinic Valmieras Veselibas centrs
Valmiera, Latvia, LV-4201
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania, LT-50009
Klaipeda University Hospital
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital Santariskiu Clinics
Vilnius, Lithuania, LT-08661
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Malaysia, 20400
Mexico
Instituto Biomedico de Investigacion A.C.
Aguascalientes, Mexico, 20127
Medica Sur, S.A.B. de C.V.
Mexico City, Distrito Federal, Mexico, 14050
Hospital y Clinica OCA, Sociedad Anonima de Capital Variable
Monterrey, Nuevo Leon, Mexico, 64000
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosi, Mexico, 78240
Netherlands
Kempenhaeghe
Heeze, Netherlands, 5591 VE
Stichting Epilepsie Instellingen Nederland
Zwolle, Netherlands, 8025 BV
Philippines
Manila Doctors Hospital
Ermita, Philippines, 1000
Makati Medical Center
Makati City, Philippines, 1229
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland, 15-276
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
Gdansk, Poland, 80-803
Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland, 40-635
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego
Lublin, Poland, 20-718
Instytut Psychiatrii i Neurologii
Warszawa, Poland, 02-957
Portugal
Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, Portugal, 3000-075
Hospital Santa Maria
Lisboa, Portugal, 1649-035
Centro Hospitalar de Sao Joao, EPE
Porto, Portugal, 4200-319
Romania
Sapiens Medical Center
Bucharest, Romania
Colentina Clinical Hospital
Bucharest, Romania, 20125
Russian Federation
Regional Children Clinical Hospital #1
Ekaterinburg, Russian Federation, 620149
Research Medical Complex Vashe Zdorovie
Kazan, Russian Federation, 420097
I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF
Moscow, Russian Federation, 119992
Moscow Research Institute of Pediatrics and Pediatric Surgery
Moscow, Russian Federation, 125412
Moscow State University of Medicine and Dentistry
Moscow, Russian Federation, 107066
Moscow Research Institute of Psychiatry
Moscow, Russian Federation, 107076
Nizhniy Novgorod State Medical Academy of Roszdrav
Nizhniy Novgorod, Russian Federation, 603005
Regional Children Clinical Hospital
Omsk, Russian Federation, 644001
Samara State Medical University
Samara, Russian Federation, 443095
Smolensk Regional Clinical Hospital
Smolensk, Russian Federation, 214018
Tyumen State Medical Academy
Tyumen, Russian Federation, 625039
Yaroslavl Clinical Hospital #8
Yaroslavl, Russian Federation, 150030
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade, Serbia, 11000
Institute of Mental Health
Belgrade, Serbia, 11000
Clinical Center NIS
Nis, Serbia, 18000
Clinical Centre of Vojvodina
Novi Sad, Serbia, 21000
South Africa
Dr M Isaacs Private Practice
Johannesburg, Gauteng, South Africa, 2196
Groote Schuur Hospital
Cape Town, Western Cape, South Africa, 7925
Tygerberg Hospital
Cape Town, South Africa, 7500
Spain
Hospital Universitario San Cecilio
Granada, Andalucia, Spain, 18012
Hospital Universitario Germans Trias i Pujol
Badalona, Cataluna, Spain, 8916
Hospital de la Santa Creu i Sant Pau
Barcelona, Cataluna, Spain, 8025
Hospital del Mar
Barcelona, Cataluna, Spain, 8003
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Comunidad Valenciana, Spain, 46009
Fundacion Hospital Alcorcon
Alcorcon, Madrid, Communidad de, Spain, 28922
Hospital Clinico San Carlos
Madrid, Madrid, Communidad de, Spain, 28040
Fundacion Jimenez Diaz
Madrid, Madrid, Communidad de, Spain, 28040
Hospital General Universitario de Valencia
Baracaldo, Pais Vasco, Spain, 48903
Sweden
Sahlgrenska Universitetssjukhuset
Goteborg, Sweden
Universitetssjukhuset i Linkoping
Linkoping, Sweden
Taiwan
Chang Gung Memorial Hospital-Kaohsiung Branch
Kaohsiung, Taiwan, 833
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Cheng Kung University Hosptial
Tainan, Taiwan, 70403
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Thailand
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Chulalongkorn University
Bangkok, Thailand, 10330
Maharaj Nakorn Chiang Mai, Chiang Mai University
Chiangmai, Thailand, 50200
Khon Kaen University
Muang, Thailand, 40002
Ukraine
Donetsk Regional Center of Science-Practical of Rehabilitation of Children with Organic Diseases of
Donetsk, Ukraine, 83052
State Institution Road Clinical Hospital of Donetsk SE Donetsk Railroad
Donetsk, Ukraine, 83114
Kharkiv Medical Academy of Postgraduate Education
Kharkiv, Ukraine, 61018
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
Kharkiv, Ukraine, 61068
Ukrainian Medical Rehabilitation Center for Children with Organic Injures of the Nervous System MoH
Kyiv, Ukraine, 4209
Kyiv City Clinical Psychoneurological Hospital #1, Treatment and Diagnostic Research Center Epilep
Kyiv, Ukraine, 4080
Lviv Regional Clinical Hospital
Lviv, Ukraine, 79010
Regional Clinical Center of Neurosurgery and Neurology.
Uzhgorod, Ukraine, 88000
United Kingdom
The Walton Centre For Neurology And Neurosurgery
Liverpool, United Kingdom, L9 7LJ
St George's Hospital
London, United Kingdom, SW17 0QT
The James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
University Hospital�of North Staffordshire NHS Trust
Stoke-on-Trent, United Kingdom, ST4 7LN
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Michelle Gee, PhD. Eisai Limited
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00735397     History of Changes
Other Study ID Numbers: E2007-G000-307
Study First Received: August 13, 2008
Last Updated: August 28, 2014
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Partial onset seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 15, 2014