295
Participants
Start Date
September 27, 2011
Primary Completion Date
August 10, 2016
Study Completion Date
August 10, 2016
Pregabalin add-on therapy
Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
Pregabalin add-on therapy
Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
Pregabalin add-on therapy
Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
Center for Neurodiagnostic and Therapeutic Services, Sta Cruz
University of Santo Tomas Hospital, Manila
HUDERF, Brussels
Cliniques Universitaires de Bruxelles Hôpital Erasme, Brussels
Capitol Medical Center Inc., Quezon City
St. Luke's Medical Center, Quezon City
Philippine Children's Medical Center, Quezon City
Centre Hospitalier Neurologique William Lennox, Ottignies
UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania, Plovdiv
Cebu Doctors' University Hospital, Cebu City
Cebu Doctors' University Hospital, Cebu City
Pécsi Tudományegyetem Klinikai Központ, Pécs
Mother and Child Healthcare Institute Dr Vukan Cupic, Belgrade
University Children's Hospital Belgrade, Belgrade
General Childrens Hospital of Athens P & A Kyriakou, Athens
General Children's Hospital Penteli, Athens
Institute for Child and Youth Healthcare of Vojvodina, Novi Sad
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki, Kielce
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS - Servizio di Farmacia, Pavia
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS, Pavia
Duke Children's Hospital and Health Center, Durham
Duke Clinical Research Unit, Durham
Paediatric Department, Ipoh
Tallahassee Neurological Clinic, Tallahassee
Pediatric Neurology, P.A., Orlando
CHU Bordeaux - Hopital des Enfants, Bordeaux
Laszlo J. Mate, M.D., P.A., North Palm Beach
Axcess Medical Research, Loxahatchee Groves
Clinical Center of Kragujevac, Kragujevac
Marmara University Pendik Training and Research Hospital, Istanbul
Ege University Medical Faculty Department of Pediatrics Health and Diseases, Izmir
Izmir Tepecik Training and Research Hospital, Izmir
Behcet Uz Children Disease and surgery Training and research hospital, Izmir
Kosair Charities Pediatric Clinical, Louisville
Kosair Children's Hospital, Louisville
University of Louisville Physicians, Louisville
Center for Clinical and Translational Science, Lexington
Kentucky Neuroscience Institute, Lexington
University of Kentucky Hospital Epilepsy Monitoring Unit, Lexington
University of Kentucky Hospital Pharmacy, UK Chandler Hosptial, Lexington
Akron Children's Hospital, Akron
"Komunalnyi zaklad Dnipropetrovska dytiacha miska klinichna likarnia", Dnipropetrovsk
"Komunalnyi zaklad Dnipropetrovska oblasna dytiacha klinichna likarnia", Dnipropetrovsk
Azienda Ospedaliero-Universitaria Meyer, Florence
Hospital Kuala Lumpur, Kuala Lumpur
A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi, Ancona
"Derzhavna ustanova Instytut nevrolohii, psykhiatrii ta narkolohii", Kharkiv
Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy,, Kharkiv
Karadeniz Technical University Faculty of Medicine Farabi Hospital, Trabzon
"Komunalna ustanova Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia,", Odesa
"Komunalna ustanova Odeska oblasna dytiacha klinichna likarnia, Oblasnyi tsentr rannoi", Odesa
Hopitaux Universitaires de Strasbourg - Hopital Hautepierre, Strasbourg
"Komunalna ustanova Odeska oblasna psykhiatrychna likarnia 2,", S. Oleksandrivka
Hôpital Mère Enfant, Bron
Arkansas Children's Hospital, Little Rock
Road Runner Research, Ltd., San Antonio
Center for Neurosciences, Tucson
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,, Uzhhorod
Children's Hospital Los Angeles, Los Angeles
Children´s Hospital Los Angeles, Los Angeles
Hopital Raymond Poincare, Garches
National University Hospital, Singapore
KK Women's and Children's Hospital, Singapore
Centrul Medical Dr. Bacos Cosma, Timișoara
"Spitalul Clinic de Urgente pentru Copii Sf. Maria,", Iași
Bnai Zion Medical Center, Haifa
Saint Peter's University Hospital, New Brunswick
Fakultni nemocnice Brno - Detska nemocnice, Brno - Cerna Pole
Fakultni nemocnice v Motole, Prague
Dr. Kenessey Albert Korhaz es Rendelointezet, Balassagyarmat
Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak, Budapest
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika, Budapest
Heim Pal Gyermekkorhaz, Neurologiai Osztaly, Budapest
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia, Budapest
Klinika Neurologii Rozwojowej, Gdansk
Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie, Krakow
Katedra i Klinika Neurologii Wieku Rozwojowego, Poznan
Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka, Wroclaw
Spitalul clinic de copii Dr. Victor Gomoiu, Bucharest
"Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia", Bucharest
Spitalul de Psihiatrie Dr. Ghe. Preda, Sibiu
Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology, Seoul
Seoul National University Hospital, Seoul
Severance Hospital, Yonsei University Health System, Seoul
Hacettepe University Medical Faculty, Ankara
"Derzhavnyi zaklad Ukrainskyi medychnyi tsentr reabilitatsii ditei z", Kyiv
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INDUSTRY