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A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Tonic Clonic Seizures

Intervention: Pregabalin Dose Level 1 (Drug); Pregabalin Dose Level 2 (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021


The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

Clinical Details

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin As Adjunctive Therapy In Pediatric And Adult Subjects With Primary Generalized Tonic Clonic Seizures - Protocol A0081105

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo during the double blind assessment phase.

Secondary outcome: Responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day PGTC seizure.


Minimum age: 5 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Seizures classified as Primary Generalized Tonic Clonic Seizures

- Must have at least 1 PGTC seizure in the 8 weeks prior to screening

- Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least

1 PGTC in each 4-week period of the baseline phase

- Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments

(stable within 28 days of screening)

- Signed informed consent and assent if a minor

- Ability to comply with daily seizure and dosing diary requirements and all study

procedures Exclusion Criteria:

- A current diagnosis of febrile seizures, or seizures related to an ongoing acute

medical illness

- Focal seizures (simple partial, complex partial, or partial becoming secondarily


- Status Epilepticus within 1 year prior to screening

- Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes

(BECTS) and Dravet syndrome

- Seizures related to drugs, alcohol, or acute medical illness

- Any change in anti-epileptic treatment regimen (type of medication or dose; VNS

alteration) within 28 days of the screening visit or during the baseline phase

- Progressive or potentially progressive structural CNS lesion or a progressive


- Progressive inborn errors of metabolism.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Medizinische Universität Innsbruck, Innsbruck 6020, Austria; Recruiting

AKH Linz, Linz 4021, Austria; Recruiting

MHAT Puls AD, Blagoevgrad 2700, Bulgaria; Recruiting

DCC Sv. Pantaleimon, Pleven 5800, Bulgaria; Recruiting

MMA - MHAT - Pleven, Pleven 5800, Bulgaria; Recruiting

MC Teodora, Ruse 7000, Bulgaria; Recruiting

DCC Sveta Anna - Sofia, Sofia 1784, Bulgaria; Recruiting

UMHAT Aleksandrovska, Sofia 1431, Bulgaria; Recruiting

University Hospital Center Split, Clinic of Neurology, Split 21000, Croatia; Recruiting

CH Dubrava [Neurology], Zagreb 10000, Croatia; Recruiting

UHC Sestre Milosrdnice, Zagreb 10000, Croatia; Recruiting

Aarhus University Hospital, Aarhus C 8000, Denmark; Recruiting

Copenhagen University Hospital, Rigshospitalet, Copenhagen 2100, Denmark; Recruiting

Odense University Hospital, Odense C 5000, Denmark; Recruiting

Tartu University Hospital, Tartu 51014, Estonia; Recruiting

CHU d'Amiens - Hopital Sud, Amiens Cedex 1 80054, France; Recruiting

Hopital Raymond Poincare, Garches 92380, France; Recruiting

Hopital Raymond Poincare - Pavillon Grosiord, Garches 92380, France; Recruiting

Hopital Raymond Poincare - Pavillon Netter, Garches 92380, France; Recruiting

CHRU de Rennes - Hôpital Pontchaillou, Rennes 35033, France; Recruiting

Athens Naval Hospital, Athens 11521, Greece; Recruiting

General Children's Hospital of Pendeli, Athens 15236, Greece; Recruiting

Neurological Institute of Athens, Athens 10676, Greece; Recruiting

University General Hospital of Thessaloniki "AHEPA", Thessaloniki 54636, Greece; Recruiting

Dr. Kenessey Albert Korhaz es Rendelointezet, Balassagyarmat H-2660, Hungary; Recruiting

MH Egeszsegugyi Kozpont, Ideggyogyaszati Osztaly, Budapest H-1134, Hungary; Recruiting

Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Neurologiai Klinika, Budapest H-1083, Hungary; Recruiting

Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika, Budapest H-1083, Hungary; Recruiting

Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako, Hodmezovasarhely H-6800, Hungary; Recruiting

Markusovszky Egyetemi Oktatokorhaz, EEG Diagnosztika, Szombathely H-9700, Hungary; Recruiting

Samsung Medical Center, Seoul 135-710, Korea, Republic of; Recruiting

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting

Atrium Medisch Centrum Parkstad - Polikliniek Neurologie, Heerlen 6419 PC, Netherlands; Recruiting

Perpetual Succour Hospital, Cebu 6000, Philippines; Recruiting

Philippine General Hospital, Manila 1000, Philippines; Recruiting

University Of Santo Tomas Hospital, Manila 1008, Philippines; Recruiting

Philippine Children's Medical Center, Quezon City 1105, Philippines; Recruiting

COPERNICUS Podmiot Leczniczy Spzoo, Gdansk 80-803, Poland; Recruiting

Neuro-Care Site Management Organization Gabriela Kłodowska-Duda, Katowice 40-749, Poland; Recruiting

NZOZ Novo-Med, Katowice 40-650, Poland; Recruiting

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Poradnia Neurologiczna, Katowice 40-123, Poland; Recruiting

Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie, Lublin 20-090, Poland; Recruiting

Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, Lublin 20-718, Poland; Recruiting

Solumed Centrum Medyczne, Poznan 60-529, Poland; Recruiting

NZOZ IGNIS dr med. Alicja Lobinska, Swidnik 21-040, Poland; Recruiting

Centrum Medyczne ''Saska Kępa'', Warszawa 03-977 Warszawa, Poland; Recruiting

Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Brasov 500283, Romania; Recruiting

CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria, Bucuresti 010042, Romania; Recruiting

Sapiens Medical Center, Bucuresti 030583, Romania; Recruiting

Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu", Iasi 700309, Romania; Recruiting

Spitalul Clinic de Urgente pentru Copii "Sf. Maria", Iasi 700309, Romania; Recruiting

Spitalul de Psihiatrie "Dr. Gh. Preda", Sibiu 550082, Romania; Recruiting

Centrul Medical Dr. Bacos Cosma, Timisoara 300314, Romania; Recruiting

Nemocnica s poliklinikou Hlohovec, s.r.o., Hlohovec 92001, Slovakia; Recruiting

Neurologicka ambulancia MUDr. Eva Gasparova, Hlohovec 92001, Slovakia; Recruiting

Neurologicka ambulancia, Krompachy 05342, Slovakia; Recruiting

Lekaren sv. Joachima a Anny, Zilina 010 01, Slovakia; Recruiting

Neuron - D.T. s.r.o., Zilina 010 01, Slovakia; Recruiting

Complejo Hospitalario Torrecárdenas, Almería 04009, Spain; Recruiting

Hacettepe University Medical Faculty, Ankara 06100, Turkey; Recruiting

Eskisehir Osmangazi University Medical Faculty Department Of Neurology, Eskisehir 26480, Turkey; Recruiting

Celal Bayar Universitesi Tip Fakultesi Noroloji Anabil, Manisa 45010, Turkey; Recruiting

Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z, Kyiv 04209, Ukraine; Recruiting

Lvivska oblasna klinichna likarnia, Lvivskyi oblasnyi protyepileptychnyi tsentr,, Lviv 79010, Ukraine; Recruiting

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,, Uzhhorod 88018, Ukraine; Recruiting

Barts Health NHS Foundation Trust, The Royal London Hospital, London E1 2AT, United Kingdom; Recruiting

Salford Royal NHS Foundation Trust, Salford M6 8HD, United Kingdom; Recruiting

ABMU Local Health Board, Morriston Hospital, Swansea SA6 6NL, United Kingdom; Recruiting

Hospital Universitario de Son Espases, Palma de Mallorca, Baleares 07010, Spain; Recruiting

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona 08907, Spain; Recruiting

CHU Brugmann - Site Horta, Brussels, Bruxelles Capitale 1020, Belgium; Recruiting

UZ Brussel - Campus Jette, Brussel, Bruxelles-Capitale 1090, Belgium; Recruiting

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States; Not yet recruiting

Cebu Doctors' University Hospital, Cebu City, Cebu 6000, Philippines; Recruiting

Pediatric Epilepsy Center of Central Florida, Orlando, Florida 32819, United States; Recruiting

Pediatric Neurology, PA, Orlando, Florida 32819, United States; Recruiting

Medsol Clinical Research Center, Port Charlotte, Florida 33952, United States; Recruiting

Axcess Medical Research, Wellington, Florida 33414, United States; Recruiting

West Georgia Sleep Disorder & Neurology Assoc, Douglasville, Georgia 30134, United States; Recruiting

Dr. Attila Csanyi, Gyor, H- 9023, Hungary; Recruiting

Precise Clinical Research Solutions, Manhattan, Kansas 66502, United States; Recruiting

Center for Clinical and Translational Science, Lexington, Kentucky 40536, United States; Recruiting

Kentucky Neuroscience Institute, Lexington, Kentucky 40536, United States; Recruiting

University of Kentucky Hospital Pharmacy - UK Chandler Hospital, Lexington, Kentucky 40536, United States; Recruiting

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea 137-701, Korea, Republic of; Recruiting

Alytaus apskrities S.Kudirkos ligonine, Lithuania, LT 62114, Lithuania; Recruiting

Hospital Universitario Fundacion Alcorcon, Alcorcón, Madrid 28922, Spain; Recruiting

Niepubliczny Zaklad Opieki Zdrowotnej "Hipokrates II" Sp. z o.o., Krakow, Malopolskie 31-223, Poland; Recruiting

Metropolitan Medical Center, Sta. Cruz, Manila 1003, Philippines; Recruiting

Newton-Wellesley Hospital, Newton, Massachusetts 02462, United States; Recruiting

Lecznica Medyczna ''Zycie", Warsaw, Mazowieckie 00-453, Poland; Terminated

Hospital Universitario Virgen de la Arrixaca, El Palmar, Murcia 30120, Spain; Recruiting

Stony Brook University, Stony Brook, New York 11794, United States; Not yet recruiting

Ohio Clinical Research Partners, LLC, Canton, Ohio 44718, United States; Terminated

Hospital Raja Permaisuri Bainun, Ipoh, Perak 30990, Malaysia; Recruiting

Neurological Clinic of Texas, P.A., Dallas, Texas 75251, United States; Recruiting

Road Runner Research, LTD, San Antonio, Texas 78258, United States; Not yet recruiting

Scott & White Memorial Hospital and Clinic, Temple, Texas 76508, United States; Recruiting

Dokuz Eylul Un. Tip Fakültesi İç Hastalıkları Nöroloji Bölüm, Izmir, Türkiye 35340, Turkey; Recruiting

LKH Bregenz University Hospital, Bregenz, Vorarlberg 6900, Austria; Recruiting

Rainier Clinical Research Center, Inc., Renton, Washington 98057, United States; Recruiting

The Barberry National Centre for Mental Health, Birmingham, West Midlands B15 2FG, United Kingdom; Recruiting

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2013
Last updated: August 12, 2015

Page last updated: August 23, 2015

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