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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 November 27, 2014
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

Summary

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.

Eligibility

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

Criteria:

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

generalized)

- 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

encephalopathy.

- 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

General Hospital for Active Treatment PULSE" AD - Blagoevgrad, Blagoevgrad 2700, Bulgaria; Recruiting

Hospital: OCC-2,, Blagoevgrad 7000, Bulgaria; Recruiting

MBAL Sveti Panteleymon,, Pleven, Bulgaria; Recruiting

Voennomeditsinska Akademia - MBAL- Pleven, Otdelenie po Nervni bolesti, Pleven 5800, Bulgaria; Recruiting

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

UHC Sestre Milosrdnice, Zagreb 10000, Croatia; Recruiting

Tartu University Hospital, Tartu 51014, Estonia; Recruiting

Centre Hospitalier Universitaire d'Amiens (Hopital Nord), Amiens 80054, France; Recruiting

Hopital Raymond Poincare, Garches 92380, France; Recruiting

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

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

MH Honvedkorhaz, 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

Erzsebet Korhaz-Rendelointezet,, Hodmezovasarhely H-6800, Hungary; Recruiting

Vas Megyei Markusovszky Korhaz Nonprofit Zrt. Orvostudomanyi 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

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

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

Uniwersyteckie Centrum Medyczne, Gdansk 80-952, Poland; Recruiting

Neuro-Care Site Management Organization Gabriela Kłodowska-Duda, Katowice 40-749, Poland; Not yet recruiting

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Poradnia Neurologiczna, Katowice 40-123, Poland; Not yet recruiting

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

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

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

Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Brasov 500283, 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

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

Celal Bayar Universitesi Tip Fakultesi Noroloji Anabil, Manisa 45010, Turkey; Not yet recruiting

Barts 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 8207, Spain; Recruiting

CHU Brugmann - Site Horta, Brussels, Bruxelles Capitale 1020, Belgium; Not yet recruiting

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States; Recruiting

Chu de Pontchaillon, Clinique Neurologique, Rennes, Cedex 35033, France; Recruiting

Neurology & Epilepsy Center of Center 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; Active, not recruiting

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

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

Southern Illinois University School of Medicine, Springfield, Illinois 62794, United States; Recruiting

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

UAB "Neuromeda", Kaunas, LT 50185, Lithuania; Recruiting

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

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

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

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

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

Eskinsehir Osmangazi University, Eskisehir, Meselik / Turkey 26480, Turkey; Recruiting

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

Schenectady Neurological Consultants, PC, Schenectady, New York 12308, United States; Recruiting

Stony Brook University, Stony Brook, New York 11794, United States; Recruiting

AKH Linz Neurologie und Psychiatrie, Linz, Oberosterreich 4021, Austria; Recruiting

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

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

Mid-South Physicians Group, Germantown, Tennessee 38138, United States; Recruiting

Road Runner Research, LTD, San Antonio, Texas 78258, United States; Recruiting

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

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

Additional Information

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

Starting date: April 2013
Last updated: November 7, 2014

Page last updated: November 27, 2014

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