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A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years

Sponsored by Pfizer

Phase Quota
Phase 3

 A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years (PERIWINKLE). Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.

Study Start Date: September 2011

Estimated Completion Date: August 2016

Specialties: Neurology: Neuro/Psych pharmacology,Peds Neurology,Seizure Pediatrics: Clinical Pharmacology,Pediatric Neurology Pharmacy: Drug Trials,Neuro/Psych pharmacology

Interventions

  • Drug: Pregabalin add-on therapy

Inclusion criteria

Exclusion criteria

Study Locations And Contact Information

  • Klinika Neurologii Rozwojowej, Gdansk
  • HUDERF, Brussels Brussels-capital
  • Samsung Medical Center Department of Pediatrics Pediatric Neurology, Seoul
  • Ege University Medical Faculty Department of Pediatrics Health and Diseases, Izmir Bornova
  • Capitol Medical Center Inc, Quezon City National Capital Region
  • Cliniques Universitaires de Bruxelles Hpital Erasme, Brussels
  • CHU Bordeaux Hopital des Enfants, Bordeaux
  • Heim Pal Gyermekkorhaz Neurologiai Osztaly, Budapest
  • Spitalul clinic de copii Dr Victor Gomoiu, Bucuresti
  • Komunalnyi zaklad Dnipropetrovska dytiacha miska klinichna likarnia, Dnipropetrovsk
  • Seoul National University Hospital, Seoul
  • AOU Ospedali Riuniti di Ancona Presidio Ospedaliero G Salesi, Ancona
  • Duke Clinical Research Unit, Durham North Carolina
  • Scott White Memorial Hospital and Clinic, Temple Texas
  • Boston Childrens Hospital, Boston Massachusetts
  • Biomedical Systems Laboratory, Saint Louis Missouri, United States
  • Azienda OspedalieroUniversitaria Meyer, Firenze
  • General Childrens Hospital of Athens P A Kyriakou, Athens
  • Center for Clinical and Translational Science, Lexington Kentucky
  • KK Womens and Childrens Hospital, Singapore
  • Heim Pal Gyermekkorhaz Neurologiai Osztaly, Budapest
  • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii neirokhirurhichne viddilennia 2, Uzhgorod
  • Fakultni nemocnice Brno Detska nemocnice, Brno - Cerna pole
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS Servizio di Farmacia, Pavia
  • Severance Hospital Yonsei University Health System, Seoul
  • Clinical Center of Kragujevac, Kragujevac
  • Hospital Kuala Lumpur, Kuala Lumpur
  • Kentucky Neuroscience Institute, Lexington Kentucky
  • Marmara University Pendik Training and Research Hospital, Istanbul Pendik
  • Cebu Doctors University Hospital, Cebu City
  • General Childrens Hospital Pendeli, Athens
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie, Krakow
  • UZ Brussel Campus Jette, Brussels Bruxelles Capitale
  • The University of Chicago Medical Center, Chicago Illinois
  • Tufts Medical CenterFloating Hospital for Children, Boston Massachusetts
  • Duke Childrens Hospital and Health Center, Durham North Carolina
  • UZ Brussel Campus Jette, Brussels Bruxelles Capitale
  • Oddzial Neurologii Dzieciecej Dolnoslaski Szpital Specjalistyczny imT Marciniaka, Wroclaw
  • Derzhavna Ustanova Instytut Nevrolohii Psykhiatrii ta Narkolohii NAMN Ukrainy, Kharkiv
  • Tallahasse Neurological Clinic, Tallahassee Florida
  • Hopital Raymond Poincare, Garches
  • Centre Hospitalier Neurologique William Lennox, Ottignies Brabant Wallon
  • Komunalna ustanova Odeska oblasna dytiacha klinichna likarnia Oblasnyi tsentr rannoi, Odesa
  • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii neirokhirurhichne viddilennia 2, Uzhgorod
  • Mother and Child Healthcare Institute Dr Vukan Cupic, Belgrade
  • Philippine Childrens Medical Center, Quezon City
  • The University of Chicago Medical Center, Chicago Illinois
  • Katedra i Klinika Neurologii Wieku Rozwojowego, Poznan
  • Mother and Child Healthcare Institute Dr Vukan Cupic, Belgrade
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS, Pavia
  • Severance Hospital Yonsei University Health System, Seoul
  • General Childrens Hospital Pendeli, Athens
  • NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki, Kielce
  • CHU Bordeaux Hopital des Enfants, Bordeaux
  • Hacettepe University Medical Faculty, Ankara Sihhiye/ankara
  • MultiCare Health System Mary Bridge Childrens Hospital and Health Center, Tacoma Washington
  • Hospital Kuala Lumpur, Kuala Lumpur
  • Spitalul Clinic de Urgente pentru Copii Sf Maria, Iasi
  • Seattle Childrens Hospital, Seattle Washington
  • Hopital Raymond Poincare, Garches
  • Seoul National University Hospital, Seoul
  • Fakultni nemocnice Brno Detska nemocnice, Brno - Cerna pole
  • Oddzial Neurologii Dzieciecej Dolnoslaski Szpital Specjalistyczny imT Marciniaka, Wroclaw
  • Spitalul de Psihiatrie Dr Ghe Preda, Sibiu
  • MultiCare Health System Mary Bridge Childrens Health Center IP Shipment Address ONLY, Tacoma Washington
  • Spitalul Clinic de Psihiatrie Prof Dr Al Obregia, Bucuresti
  • Komunalnyi zaklad Dnipropetrovska oblasna dytiacha klinichna likarnia, Dnipropetrovsk
  • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz Gyermekneurologia, Budapest
  • Kosair Childrens Hospital, Louisville Kentucky
  • St Lukes Medical Center, Quezon City
  • Centrum Medyczne SaskaKepa, Warszawa
  • Pediatric Epilepsy and Neurology Specialists PA, Tampa Florida
  • Komunalna ustanova Odeska oblasna psykhiatrychna likarnia 2, s. Oleksandrivka
  • Centrul Medical Dr Bacos Cosma, Timisoara
  • Hopitaux Universitaires de Strasbourg Hopital Hautepierre, Strasbourg
  • Szent Janos Korhaz es Eszakbudai Egyesitett Korhazak, Budapest
  • Pcsi Tudomnyegyetem Klinikai Kzpont, Pécs
  • Behcet Uz Children Disease and surgery Training and research hospital, Izmir Konak
  • Pediatric Neurology PA, Orlando Florida
  • Road Runner Research Ltd, San Antonio Texas
  • University of Kentucky Hospital Epilepsy Monitoring Unit, Lexington Kentucky
  • Bnai Zion Medical Center, Haifa
  • Dr Kenessey Albert Korhaz es Rendelointezet, Balassagyarmat
  • Dr Kenessey Albert Korhaz es Rendelointezet, Balassagyarmat
  • St Lukes Medical Center, Quezon City
  • Kosair Childrens Hospital, Louisville Kentucky
  • University of Louisville Physicians, Louisville Kentucky
  • Klinika Neurologii Rozwojowej, Gdansk
  • Hopitaux Universitaires de Strasbourg Hopital Hautepierre, Strasbourg
  • McLane Childrens Scott White Clinic Temple, Temple Texas
  • Institute for Child and Youth Healthcare of Vojvodina, Novi Sad Vojvodina
  • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz Gyermekneurologia, Budapest
  • Azienda OspedalieroUniversitaria Meyer, Firenze
  • MultiCare Institute for Research Innovation, Tacoma Washington
  • Clinical Research Center of New Jersey, Voorhees New Jersey
  • MultiCare Health System Mary Bridge Childrens Health Center IP Shipment Address ONLY, Tacoma Washington
  • Komunalnyi zaklad Dnipropetrovska oblasna dytiacha klinichna likarnia, Dnipropetrovsk
  • Hpital Mre Enfant, Bron
  • UZ Leuven, Leuven
  • Izmir Tepecik Training and Research Hospital, Izmir Konak
  • Scott White Memorial Hospital and Clinic, Temple Texas
  • Saint Peters University Hospital, New Brunswick New Jersey
  • Kentucky Neuroscience Institute, Lexington Kentucky
  • Samsung Medical Center Department of Pediatrics Pediatric Neurology, Seoul
  • Komunalna ustanova Odeska oblasna dytiacha klinichna likarnia Oblasnyi tsentr rannoi, Odesa
  • Axcess Medical Research, Loxahatchee Florida
  • Komunalna ustanova Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia, Odesa
  • Spitalul Clinic de Psihiatrie Prof Dr Al Obregia, Bucuresti
  • Derzhavna ustanova Instytut nevrolohii psykhiatrii ta narkolohii, Kharkiv
  • Seattle Childrens Hospital, Seattle Washington
  • Fakultni nemocnice v Motole, Praha 5
  • Saint Peters University Hospital, New Brunswick New Jersey
  • Behcet Uz Children Disease and surgery Training and research hospital, Izmir Konak
  • Komunalnyi zaklad Dnipropetrovska dytiacha miska klinichna likarnia, Dnipropetrovsk
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS Servizio di Farmacia, Pavia
  • Spitalul de Psihiatrie Dr Ghe Preda, Sibiu
  • Paediatric Department, Ipoh Perak
  • National University Hospital, Singapore
  • Semmelweis Egyetem I Sz Gyermekgyogyaszati Klinika, Budapest
  • University of Kentucky Hospital Pharmacy UK Chandler Hosptial, Lexington Kentucky
  • Derzhavnyi zaklad Ukrainskyi medychnyi tsentr reabilitatsii ditei z, Kyiv
  • Center for Neurosciences, Tucson Arizona
  • Spitalul clinic de copii Dr Victor Gomoiu, Bucuresti
  • Fakultni nemocnice v Motole, Praha 5
  • Arkansas Childrens Hospital, Little Rock Arkansas
  • Karadeniz Technical University Faculty of Medicine Farabi Hospital, Trabzon Farabi
  • National University Hospital, Singapore
  • Komunalna ustanova Odeska oblasna psykhiatrychna likarnia 2, s. Oleksandrivka
  • University of Santo Tomas Hospital, Manila
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie, Krakow
  • Komunalna ustanova Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia, Odesa
  • Hpital Mre Enfant, Bron
  • Pcsi Tudomnyegyetem Klinikai Kzpont, Pécs
  • HUDERF, Brussels Brussels-capital
  • General Childrens Hospital of Athens P A Kyriakou, Athens
  • Childrens Hospital Los Angeles, Los Angeles California
  • Centre Hospitalier Neurologique William Lennox, Ottignies Brabant Wallon
  • Cliniques Universitaires de Bruxelles Hpital Erasme, Brussels
  • Semmelweis Egyetem I Sz Gyermekgyogyaszati Klinika, Budapest
  • Boston Childrens Hospital, Boston Massachusetts
  • KK Womens and Childrens Hospital, Singapore
  • Derzhavna Ustanova Instytut Nevrolohii Psykhiatrii ta Narkolohii NAMN Ukrainy, Kharkiv
  • University Childrens Hospital Belgrade, Belgrade
  • Katedra i Klinika Neurologii Wieku Rozwojowego, Poznan
  • Derzhavna ustanova Instytut nevrolohii psykhiatrii ta narkolohii, Kharkiv
  • Cebu Doctors University Hospital, Cebu City Cebu
  • Center for Neurodiagnostic and Therapeutic Services, Sta. Cruz Manila
  • Rocket Pediatrics at University of Toledo Medical Center, Toledo Ohio
  • MultiCare Health System Mary Bridge Childrens Hospital and Health Center, Tacoma Washington
  • UMBAL Sveti Georgi Klinika po pediatria i genetichni zabolyavania, Plovdiv
  • Institute for Child and Youth Healthcare of Vojvodina, Novi Sad Vojvodina
  • Philippine Childrens Medical Center, Quezon City
  • Centrum Medyczne SaskaKepa, Warszawa
  • Derzhavnyi zaklad Ukrainskyi medychnyi tsentr reabilitatsii ditei z, Kyiv
  • UMBAL Sveti Georgi Klinika po pediatria i genetichni zabolyavania, Plovdiv
  • Centrul Medical Dr Bacos Cosma, Timisoara
  • Akron Childrens Hospital, Akron Ohio
  • Szent Janos Korhaz es Eszakbudai Egyesitett Korhazak, Budapest
  • Spitalul Clinic de Urgente pentru Copii Sf Maria, Iasi
  • Clinical Center of Kragujevac, Kragujevac
  • McLane Childrens Scott White Clinic Temple, Temple Texas
  • Laszlo J Mate MD PA, North Palm Beach Florida
  • University of Santo Tomas Hospital, Manila
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS, Pavia
  • Bnai Zion Medical Center, Haifa
  • Cebu Doctors University Hospital, Cebu City Cebu
  • Cebu Doctors University Hospital, Cebu City
  • UZ Leuven, Leuven
  • Road Runner Research Ltd, San Antonio Texas
  • Clinical Research Center of New Jersey, Voorhees New Jersey
  • University Childrens Hospital Belgrade, Belgrade
  • Capitol Medical Center Inc, Quezon City National Capital Region
  • AOU Ospedali Riuniti di Ancona Presidio Ospedaliero G Salesi, Ancona
  • Pediatric Neurology Epilepsy Center, Orlando Florida
  • NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki, Kielce

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