Once-A-Day Pregabalin For Partial Seizures

Last updated: January 21, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

3

Condition

Seizure Disorders (Pediatric)

Epilepsy

Treatment

N/A

Clinical Study ID

NCT01262677
A0081194
2010-019035-35
  • Ages > 18
  • All Genders

Study Summary

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex,with or without evolution into a bilateral, convulsive seizure)
  • Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who havetaken at least 2 prior (or ongoing) AEDs

Exclusion

Exclusion Criteria:

  • Primary generalized seizures (for example, absence, myoclonic seizures orLennox-Gastaut Syndrome)
  • Status epilepticus within one year prior to screening

Study Design

Total Participants: 325
Study Start date:
February 17, 2011
Estimated Completion Date:
August 01, 2012

Connect with a study center

  • Fundacion Argentina Contra las Enfermedades Neurologicas (FACENE)

    Ciudad Autonoma de Buenos Aires, C1117ABE
    Argentina

    Site Not Available

  • FLENI(Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia)

    Ciudad Autónoma de Buenos Aires, C1428AQK
    Argentina

    Site Not Available

  • FLENI(Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia)

    Ciudad Autónoma de Buenos Aires, C1428AQK
    Argentina

    Site Not Available

  • Clinic of Neurology,Clinical Centar University Sarajevo

    Sarajevo, 71000
    Bosnia and Herzegovina

    Site Not Available

  • MBAL Puls AD, Nevrologichno otdelenie

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • UMBAL Dr. Georgi Stranski, Vtora nevrologichna klinika

    Pleven, 5800
    Bulgaria

    Site Not Available

  • DKTs Akta Medika, Konsultativen kabinet po Nevrologiya

    Sevlievo, 5400
    Bulgaria

    Site Not Available

  • MBALNP Sveti Naum EAD, Klinika po nervni bolesti za paroksizmalnite sastoyaniya,

    Sofia, 1113
    Bulgaria

    Site Not Available

  • Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Nevrologichno Otdelenie

    Sofia, 1202
    Bulgaria

    Site Not Available

  • Clinic of Neurology,University Hospital Center Split

    Split, 21000
    Croatia

    Site Not Available

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91
    Czech Republic

    Site Not Available

  • Litomyslská nemocnice, a.s.

    Litomysl, 570 14
    Czechia

    Site Not Available

  • Fakultni Thomayerova nemocnice s poliklinikou,Neurologicka klinika IPVZ/FTNsP

    Praha 4, 140 59
    Czechia

    Site Not Available

  • Neurologicka ambulance

    Praha 6, 160 00
    Czechia

    Site Not Available

  • Epilepsie-Zentrum Bethel

    Bielefeld, 33617
    Germany

    Site Not Available

  • Praxis fuer Neurologie und Psychiatrie, Psychotherapie

    Bielefeld, 33647
    Germany

    Site Not Available

  • Klinik fuer Epileptologie, Universitaet Bonn

    Bonn, 53105
    Germany

    Site Not Available

  • Neuro Consil GmbH

    Duesseldorf, 40212
    Germany

    Site Not Available

  • Epilepsieklinik fuer Erwachsene Epilepsiezentrum Kork

    Kehl-Kork, 77694
    Germany

    Site Not Available

  • Studienzentrum Dr. Stephan Arnold

    Muenchen, 80638
    Germany

    Site Not Available

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Department of Medicine, Queen Elizabeth Hospital

    Kowloon, 0
    Hong Kong

    Site Not Available

  • Dr. Kennessey Albert Korhaz-Rendelointezet, Neurologiai Osztaly

    Balassagyarmat, 2660
    Hungary

    Site Not Available

  • Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Ideggyogyaszati Osztaly

    Budapest, 1145
    Hungary

    Site Not Available

  • Synexus Magyarorszag Kft.

    Budapest, 1036
    Hungary

    Site Not Available

  • Szent Pantaleon Korhaz Nonprofit Kft., Idegosztaly

    Dunaujvaros, 2400
    Hungary

    Site Not Available

  • Lalitha Super Specialities Hospital (P) Ltd.

    Guntur, Andhra Pradesh 522 001
    India

    Site Not Available

  • Jagadguru Sri Shivathreeshwara Medical College and Hospital,

    Mysore, Karnataka 570004
    India

    Site Not Available

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashtra 411 004
    India

    Site Not Available

  • KEM Hospital Research Centre

    Pune, Maharashtra 411 011
    India

    Site Not Available

  • Poona Hospital and Research Centre Department of Neurology

    Pune, Maharashtra 411030
    India

    Site Not Available

  • Sahyadri Clinical Research & Development Center,

    Pune, Maharashtra 411 004
    India

    Site Not Available

  • Sahyadri Speciality Hospital

    Pune, Maharashtra 411004
    India

    Site Not Available

  • Vidyasagar Institute of Mental Health , Neuro& Allied Sciences,

    Nehru Nagar, NEW Delhi 110 065
    India

    Site Not Available

  • Jabatan Neurosains, Pusat Pengajian Sains Perubatan, Universiti Sains Malaysia.

    Kubang Kerian, Kelantan 16150
    Malaysia

    Site Not Available

  • Hospital Universiti Sains Malaysia

    Kelantan Darul Naim,
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586
    Malaysia

    Site Not Available

  • Private Office 201

    Delagación Cuauhtemoc, DF 06700
    Mexico

    Site Not Available

  • Private Office 201

    Delagación Cuauhtemoc, DF 06700
    Mexico

    Site Not Available

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco 44280
    Mexico

    Site Not Available

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo LEON CP 64460
    Mexico

    Site Not Available

  • Hospital Angeles Culiacan

    Culiacan, Sinaloa 80020
    Mexico

    Site Not Available

  • Instituto Biomedico de Investigacion A. C.

    Aguascalientes, 20127
    Mexico

    Site Not Available

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Gdansk, 80-266
    Poland

    Site Not Available

  • Centrum Medyczne Dendryt

    Katowice, 40-683
    Poland

    Site Not Available

  • Centrum Neurologii Klinicznej Sp. z o. o.

    Krakow, 31-505
    Poland

    Site Not Available

  • Gabinet Lekarski A. Klimek

    Lodz, 90-148
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej IGNIS dr med. Alicja Lobinska

    Swidnik, 21-040
    Poland

    Site Not Available

  • Epilepsy Control Institute

    San Juan, 00923
    Puerto Rico

    Site Not Available

  • Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"

    Iasi, Jud. Iasi 700309
    Romania

    Site Not Available

  • Cabinet Medical Individual " Dr. Adina Maria Roceanu"

    Bucuresti, 010042
    Romania

    Site Not Available

  • Municipal Healthcare Institution City Hospital #5, Neurology Department

    Barnaul, 656045
    Russian Federation

    Site Not Available

  • State Medical Institution Republican Clinical Hospital

    Kazan, 420064
    Russian Federation

    Site Not Available

  • Central Clinical Hospital #2 N.A. Semashko OAO RZD / Department of Rehabilitation

    Moscow, 107150
    Russian Federation

    Site Not Available

  • Pyatigorsk City Hospital #2, Neurology Department,

    Pyatigorsk, 357538
    Russian Federation

    Site Not Available

  • State Institution St. Petersburg Psychoneurological Research Institute V.M. Bekhterev of Roszdrav

    Saint-Petersburg, 192019
    Russian Federation

    Site Not Available

  • Samara Regional Clinical Hospital M.I. Kalinin, Neurology and Neurosurgery Department

    Samara, 443095
    Russian Federation

    Site Not Available

  • Institute for Mental Health

    Belgrade, 11 000
    Serbia

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Site Not Available

  • St Augustine's Medical Mews

    Durban, KwaZulu Natal 4001
    South Africa

    Site Not Available

  • Netcare Umhlanga Medical Centre

    Umhlanga, 4320
    South Africa

    Site Not Available

  • Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine

    Muang, Khon Kaen 40002
    Thailand

    Site Not Available

  • Neurology Division, Department of Medicine, Pramongkutklao College of Medicine

    Bangkok, 10400
    Thailand

    Site Not Available

  • Neurology Clinic, PC

    Northport, Alabama 35476
    United States

    Site Not Available

  • NEA Baptist Clinic

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Clinical Trials, Inc.

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Collaborative Neuroscience Network, Inc.

    Long Beach, California 90806
    United States

    Site Not Available

  • Viking Clinic Research Center

    Murrieta, California 92562
    United States

    Site Not Available

  • Viking Clinical Research Center

    Murrieta, California 92562
    United States

    Site Not Available

  • Neurological Research Institute

    Santa Monica, California 90404
    United States

    Site Not Available

  • Viking Clinical Research Center

    Temecula, California 92591
    United States

    Site Not Available

  • Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Optima Neurological Services, LLC

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Sarkis Clinical Trials

    Gainesville, Florida 32607
    United States

    Site Not Available

  • University of Florida Health Sciences Center, Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Sleep Disorders Center of Georgia - Gainesville

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Sleep Disorders Center of Georgia

    Gainsville, Georgia 30501
    United States

    Site Not Available

  • South Suburban Neurology

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62702
    United States

    Site Not Available

  • VCMA Comprehensive Epilepsy Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Via Christi Research

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Associates in Neurology, PSC

    Lexington, Kentucky 40513
    United States

    Site Not Available

  • Leonard J. Chabert Medical Center

    Houma, Louisiana 70363
    United States

    Site Not Available

  • Mid Atlantic Headache Institute

    Pikesville, Maryland 21208
    United States

    Site Not Available

  • Minneapolis Clinic of Neurology

    Minneapolis, Minnesota 55422
    United States

    Site Not Available

  • NJ Neuroscience Institute

    Edison, New Jersey 08818
    United States

    Site Not Available

  • Neurological Care of CNY

    Liverpool, New York 13088
    United States

    Site Not Available

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina 28806
    United States

    Site Not Available

  • Neurology Specialists, Inc.

    Dayton, Ohio 45417
    United States

    Site Not Available

  • University of Toledo Medical Center, Department of Neurology

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Veroniqe Sebastian, MD

    Oklahoma, Oklahoma 73120
    United States

    Site Not Available

  • Angelique Barreto, MD

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Mark A. Fisher, M.D.- Private Practice

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Sooner Clinical Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Veroniqe Sebastian, MD

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Site Not Available

  • Scott & White Healthcare

    Temple, Texas 76508
    United States

    Site Not Available

  • Scott and White Healthcare-Office of Sponsored Research Administration

    Temple, Texas 76502
    United States

    Site Not Available

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