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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

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

Condition(s) targeted: Epilepsy, Partial Seizures

Intervention: Pregabalin add-on therapy (Drug); Pregabalin add-on therapy (Drug); Pregabalin add-on therapy (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

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.

Clinical Details

Official title: A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 4 -16 Years Of Age With Partial Onset Seizures

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

Primary outcome: Log transformed (loge) 28 day seizure rate for all partial onset seizures collected during the 12 week double-blind treatment phase, reported as "percent reduction in seizures" relative to placebo.

Secondary outcome: Responder Rate, defined as subjects who have a 50% or greater reduction in partial seizure rate from baseline during the double-blind treatment phase.

Eligibility

Minimum age: 4 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects and/or parent(s)/legally acceptable representative must be considered

willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency.

- Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the

Screening Visit.

- Diagnosis of epilepsy with partial onset seizures classified as simple partial,

complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Diagnosis criteria.

- Must have a partial onset seizure frequency of at least 3 seizures per 28 day period

prior to screening. Must have a partial onset seizure frequency of at least 6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization.

- Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28

days prior to screening). Exclusion Criteria:

- Primary generalized seizures (including in the setting of co-existing partial onset

seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note that partial onset seizures that become secondarily generalized are not exclusionary); Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic seizures.

- Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and

Dravet syndrome.

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

medical illness. Any febrile seizures within 1 year of screening.

- Status epilepticus within 1 year prior to screening.

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

- Any change in AED regimen (type of medication or dose) within 28 days of the

Screening Visit or during the Baseline Phase.

- Progressive structural CNS lesion or a progressive encephalopathy.

Locations and Contacts

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

Hospital Erasme, Brussels 1070, Belgium; Recruiting

HUDERF, Brussels 1020, Belgium; Recruiting

UZ Leuven, Leuven 3000, Belgium; Recruiting

UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania, Plovdiv 4000, Bulgaria; Recruiting

Fakultni nemocnice Brno - Detska nemocnice, Brno - Cerna pole 613 00, Czech Republic; Active, not recruiting

Fakultni nemocnice v Motole, Praha 5 150 06, Czech Republic; Recruiting

Tartu University Hospital, Children's Clinic, Tartu 51014, Estonia; Recruiting

OYS, Lasten ja nuorten klinikka, lastenneurologian yksikkö, OYS, Oulu 90029, Finland; Recruiting

TAYS, Lastenneurologian yksikkö, Tampere 33520, Finland; Recruiting

Unite de neurologie pediatrique, Bordeaux Cedex 33076, France; Recruiting

Hôpital Femme Mère Enfant, Bron cedex 69677, France; Recruiting

Hopital Raymond Poincare, Garches 92380, France; Recruiting

Hopitaux Universitaires de Strasbourg, Hopital de Hautepierre, Strasbourg 67100, France; Recruiting

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

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

Heim Pal Gyermekkorhaz, Neurologiai Osztaly, Budapest 1089, Hungary; Terminated

Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia, Budapest 1146, Hungary; Recruiting

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

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Budapest 1023, Hungary; Recruiting

A.O.U. Ospedali Riuniti di Ancona- Presidio Ospedaliero G. Salesi, Ancona 60123, Italy; Recruiting

Azienda Ospedaliero-Universitaria Meyer, Firenze 50139, Italy; Recruiting

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, Foggia 71122, Italy; Recruiting

Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS, Pavia 27100, Italy; Recruiting

A.O. Città della Salute e della Scienza di Torino Presidio Ospedaliero O.I.R.M.- Sant' Anna, Torino 10126, Italy; Recruiting

Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology, Seoul 135-710, Korea, Republic of; Recruiting

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

Severance Hospital, Yonsei University Health System, Seoul 120-752, Korea, Republic of; Active, not recruiting

Hospital Kuala Lumpur, Kuala Lumpur 50586, Malaysia; Recruiting

SEIN Epilepsy Institutes in the Netherlands Foundation, Zwolle 8025 BV, Netherlands; Recruiting

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

Cebu Doctor University Hospital, Cebu 6000, Philippines; Recruiting

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

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

St. Luke's Medical Center, Quezon City 1102, Philippines; Terminated

Klinika Neurologii Rozwojowej, Gdansk 80-952, Poland; Recruiting

NEURO-CARE Site Management Organization Gabriela Klodowska-Duda, Katowice 40-749, Poland; Recruiting

NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki, Kielce 25-316, Poland; Recruiting

Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie, Krakow 31-503, Poland; Recruiting

Katedra i Klinika Neurologii Wieku Rozwojowego, Poznan 60-355, Poland; Recruiting

Centrum Medyczne "Saska-Kepa", Warszawa 03-977, Poland; Recruiting

Oddzial Neurologii Dzieciecej, Wroclaw 50-420, Poland; Recruiting

Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia", Bucuresti 041914, Romania; Recruiting

Spitalul de copii "Dr. Victor Gomoiu", Bucuresti 022102, Romania; Recruiting

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

Spitalul de Psihiatrie Dr. Ghe. Preda, Sibiu 550 082, Romania; Recruiting

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

Mother and Child Health Care Institute of Serbia "Dr Vukan Cupic", Pediatric Clinic, Belgrade 11000, Serbia; Recruiting

University Children's Hospital, Department for Neurology, Belgrade 11000, Serbia; Recruiting

Clinical center Kragujevac Clinic of pediatric, Kragujevac 34000, Serbia; Recruiting

Institute for Child and Youth Health Care of Vojvodina, Novi Sad 21000, Serbia; Recruiting

KK Women's and Children's Hospital, Singapore 229899, Singapore; Recruiting

National University Hospital, Singapore 119074, Singapore; Recruiting

Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia, Dnipropetrovsk 49027, Ukraine; Recruiting

Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi, Odesa 65031, Ukraine; Recruiting

Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",, Odesa 65006, Ukraine; Recruiting

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, neirokhirurhichne viddilennia №2,, Uzhgorod 88018, Ukraine; Recruiting

Center for Neurosciences, Tucson, Arizona 85718, United States; Active, not recruiting

Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States; Active, not recruiting

Centre Hospitalier Neurologique William Lennox, Ottignies, Brabant Wallon 1340, Belgium; Recruiting

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

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

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

Karadeniz Technical University Faculty of Medicine Farabi Hospital, Trabzon, Farabi 61080, Turkey; Recruiting

Laszlo J. Mate, M.D., P.A., North Palm Beach, Florida 33408, United States; Recruiting

Pediatric Neurology Epilepsy Center, Orlando, Florida 32819, United States; Recruiting

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

Tallahasse Neurological Clinic, Tallahassee, Florida 32308, United States; Recruiting

Pediatric Epilepsy and Neurology Specialists, PA, Tampa, Florida 33609, United States; Recruiting

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

Ege Universitesi Tip Fakultesi, Bornova, Izmir 35100, Turkey; 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 Epilepsy Monitoring Unit, Lexington, Kentucky 40536, United States; Recruiting

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

Kosair Children's Hospital, Louisville, Kentucky 40202, United States; Recruiting

University of Louisville Physicians, Louisville, Kentucky 40202, United States; Recruiting

Behcet Uz Cocuk Hastalıkları ve Cerrahisi Eg. ve Aras. Hastanesi, Izmir, Konak 35210, Turkey; Recruiting

Tepecik Egitim ve Arastirma Hastanesi, Izmir, Konak 35120, Turkey; Recruiting

Center for Neurodiagnostic and Therapeutic Services, Sta. Cruz, Manila 1003, Philippines; Recruiting

Boston Children's Hospital, Boston, Massachusetts 02115, United States; Recruiting

Capitol Medical Center Inc., Quezon City, National Capital Region 1100, Philippines; Recruiting

Clinical Research Center of New Jersey, Gibbsboro, New Jersey 08026, United States; Recruiting

Saint Peter's University Hospital, New Brunswick, New Jersey 08901, United States; Recruiting

Saint Peters University Hospital, New Brunswick, New Jersey 08901, United States; Recruiting

Duke University Medical Center, Children's Health Center, Durham, North Carolina 27710, United States; Terminated

Akron Children's Hospital, Akron, Ohio 44308, United States; Recruiting

Rocket Pediatrics at University of Toledo Medical Center, Toledo, Ohio 43614, United States; Recruiting

Eskisehir Osmangazi Universitesi Tip Fakultesi, Eskisehir, Osmangazi Kampusu 26480, Turkey; Recruiting

Marmara University Pendik Training and Research Hospital, Istanbul, Pendik 34890, Turkey; Recruiting

Paediatric Department, Ipoh, Perak 30990, Malaysia; Recruiting

Hacettepe University Medical Faculty Tip Fakultesi, Ankara, Sihhiye/Ankara 06100, Turkey; Recruiting

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

McLane Children's Scott & White Clinic - Temple, Temple, Texas 76502, United States; Recruiting

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

Additional Information

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

Starting date: September 2011
Last updated: August 5, 2015

Page last updated: August 23, 2015

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