Last updated on July 2018

A Safety Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.


Brief description of study

This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.

Clinical Study Identifier: NCT02072824

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Pediatric Epilepsy Center of Central Florida
Orlando, FL United States

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Pediatric Neurology, PA
Orlando, FL United States

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Pediatric Epilepsy & Neurology Specialists, PA
Tampa, FL United States

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Kosair Charities Pediatric Clinical Research Unit
Louisville, KY United States

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University of Louisville Physicians
Louisville, KY United States

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Tufts Medical Center/Floating Hospital for Children
Boston, MA United States

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Boston Children's Hospital
Boston, MA United States

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Children's Hospitals and Clinics of Minnesota - St. Paul
Saint Paul, MN United States

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Minnesota Epilepsy Group, P.A.
Saint Paul, MN United States

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Saint Peter's University Hospital
New Brunswick, NJ United States

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SUNY Downstate Medical Center
Brooklyn, NY United States

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Akron Children's Hospital
Akron, OH United States

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The University of Texas Health Science Center at Houston
Houston, TX United States

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Seattle Children's Hospital
Seattle, WA United States

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Mary Bridge Pediatrics - Tacoma
Tacoma, WA United States

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MultiCare Health System Mary Bridge Childrens Hospital and Health Center
Tacoma, WA United States

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MultiCare Institute for Research & Innovation
Tacoma, WA United States

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MultiCare Health System - Mary Bridge Children's Health Center (IP Shipment Address ONLY)
Tacoma, WA United States

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Instituto FLENI
Caba, Argentina

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Hospital de Ni os "Dr. Orlando Alassia"
Santa Fe, Argentina

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GU Republican Scientific and Practical Center Mother and Child
Minsk, Belarus

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UZ Brussel
Brussels, Belgium

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UMHAT Dr. Georgi Stranski Ltd.
Pleven, Bulgaria

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UMHAT "Sveti Georgi" Ltd.
Plovdiv, Bulgaria

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Beijing Children's Hospital
Beijing, China

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The First Bethune Hospital of Jilin University
Changchun, China

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Children's Hospital of Fudan University
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Hopital Raymond Poincare
Garches, France

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Universit tsklinikum Jena
Jena, Germany

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Uniklinikum Erlangen Kinder -und Jugendklinik
Erlangen, Germany

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General Children's Hospital "Aglaia Kyriakou"
Athens, Greece

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Budapest, Hungary

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Budapest, Hungary

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Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
Budapest, Hungary

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Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
Budapest, Hungary

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Debreceni Egyetem Klinikai K zpont
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Bnai Zion Medical Center
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Meir Medical Center
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Nizhniy Novgorod, Russian Federation

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Perm State Medical University n. a. acad. E.A. Vagner
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St. Petersburg State Pediatric Medical University
Saint Petersburg, Russian Federation

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"Baltiyskaya Medicyna" LLC
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LLC Medical Technologies
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Institute for Child and Youth Healthcare of Vojvodina
Novi Sad, Serbia

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Mother and Child Health Care Institute of Serbia "Dr Vukan Cupic"
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University Children's Hospital Belgrade
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Hopitaux Universitaires de Strasbourg, Hopital Hautepierre
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Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2
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