A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures

PHASE3CompletedINTERVENTIONAL
Enrollment

605

Participants

Timeline

Start Date

February 21, 2012

Primary Completion Date

August 22, 2019

Study Completion Date

August 22, 2019

Conditions
Epilepsy, Partial SeizuresEpilepsy, Primary Generalized Tonic-Clonic Seizures
Interventions
DRUG

Pregabalin

Pregabalin administered as either capsule or liquid oral formulations. Subjects \<4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.

Trial Locations (151)

100

National Taiwan University Hospital, Taipei

833

Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch, Kaohsiung City

1000

Manila Doctors Hospital, Manila

1003

Metropolitan Medical Center, Manila

1008

University of Santo Tomas Hospital, Manila

1020

Hopital Universitaire Des Enfants Reine Fabiola, Brussels

1070

Hospital Erasme, Brussels

1083

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

1090

UZ Brussel - Campus Jette - Pediatric Neurology, Brussels

1100

Capitol Medical Center Inc., Quezon City

1102

St. Luke's Medical Center, Quezon City

1105

Philippine Children's Medical Center, Diliman, Quezon City

1113

MHATNP Sveti Naum EAD, Sofia

1784

DCC Sveta Anna - Sofia\ Neurological room, Sofia

2143

Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly, Kistarcsa

2700

"Multiprofile Hospital for Active Treatment Puls AD", Blagoevgrad

4000

MHAT Central Onco Hospital OOD, Plovdiv

"UMHAT Sveti Georgi Ltd., Pediatric Clinic", Plovdiv

5800

UMHAT Dr. Georgi Stranski Ltd., Pleven

6000

Cebu Doctors' University Hospital, Cebu City

Perpetual Succour Hospital, Cebu City

7623

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

10400

Phramongkutklao Hospital, Neurology Unit,, Ratchathevee, Bangkok

10700

Siriraj Hospital, Mahidol University, Faculty of Medicine, Bangkoknoi

11000

Mother and Child Healthcare Institute Dr Vukan Cupic, Belgrade

University Children's Hospital Belgrade, Belgrade

11527

"General Children's Hospital of Athens P&A Kyriakou", Athens

15224

Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh

15236

General Children's Hospital Penteli, Athens

15586

Hospital Raja Perempuan Zainab II, Kota Bharu

19104

The children's Hospital of Philadelphia, Philadelphia

21000

Institute for Child and Youth Healthcare of Vojvodina, Novi Sad

26480

Eskisehir Osmangazi University Medical Faculty, Eskişehir

27100

Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS, Pavia

30990

Hospital Raja Permaisuri Bainun, Ipoh

32308

Tallahassee Neurological Clinic, Tallahassee

32819

Pediatric Epilepsy Center Of Central Florida, Orlando

Pediatric Neurology, PA, Orlando

33408

Laszlo J. Mate, M.D., P.A., North Palm Beach

33470

Axcess Medical Research, Loxahatchee Groves

33609

Pediatric Epilepsy and Neurology Specialists, PA, Tampa

34000

Clinical Center of Kragujevac, Kragujevac

34340

Dokuz Eylül University medical Faculty Internal Medicine Disease, Izmir

35033

CHRU de Rennes - Hopital Pontchaillou, Rennes

35100

Ege University Medical Faculty Department of Pediatrics Health and Diseases,, Izmir

35120

Izmir Tepecik Training and Research Hospital, Izmir

35210

Behcet Uz Children Disease and Surgery Training and Research Hospital, Izmir

40202

Kosair Children's Hospital, Louisville

University of Louisville Physicians, Louisville

40447

China Medical University Hospital, Taichung

44308

Akron Children's Hospital, Akron

44718

Ohio Clinical Research Partners, LLC, Canton

46237

Josephson Wallack Munshower Neurology P.C., Indianapolis

49027

"Komunalnyi zaklad Dnipropetrovska dytiacha miska klinichna likarnia #5", Dnipro

49100

"Komunalnyi zaklad Dnipropetrovska oblasna dytiacha klinichna likarnia", Dnipropetrovsk

50009

Hospital Universitario Miguel Servet, Zaragoza

50139

Azienda Ospedaliero-Universitaria Meyer, Florence

50586

Hospital Kuala Lumpur, Kuala Lumpur

60123

A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia, Ancona

A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi, Ancona

61068

"Derzhavna ustanova Instytut nevrolohii, psykhiatrii ta narkolohii", Kharkiv

"Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasna klinichna psykhiatrychna li", Kharkiv

61080

Karadeniz Technical University Faculty of Medicine Farabi Hospital, Trabzon

65006

"Komunalna ustanova Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia", Odesa

"Komunalne nekomertsiine pidpryiemstvo Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa", Odesa

65031

"KU Odeska oblasna dytiacha klinichna likarnia", Odesa

67098

Hopitaux Universitaire de Strasbourg - Hopital Hautepierre, Strasbourg

67513

"Komunalna ustanova Odeska oblasna psykhiatrychna likarnia No2", S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl.

69068

"Komunalna ustanova Miska klinichna likarnia #2, nevrolohichne viddilennia", Zaporizhzhia

71000

University Clinical Center Sarajevo, Sarajevo

72202

Arkansas Children's Hospital, Little Rock

75230

Dallas Pediatric Neurology Associates, Dallas

76018

Ivano-Frankivska oblasna dytiacha klinichna likarnia, Ivano-Frankivsk

78249

Road Runner Research, Ltd., San Antonio

79010

Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv, Lviv

79101

"Public Health Institution Hospital Dr. Mladen Stojanovic", Prijedor

84000

Pzu Neuron, Bijelo Polje

85718

Center for Neurosciences, Tucson

88000

University Clinical Hospital Mostar, Mostar

88018

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2, Uzhhorod

90027

Children's Hospital Los Angeles, Los Angeles

92001

Neurologicka ambulancia MUDr. Eva Gasparova, Hlohovec

92380

Hopital Raymond Poincare, Garches

96817

Hawaii Pacific Neuroscience, Honolulu

98057

Rainier Clinical Research Center, Inc., Renton

117997

FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia, Moscow

119074

National University Hospital, Singapore

125412

FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia, Moscow

129128

Non-state Healthcare Institution, Moscow

130021

The First Bethune Hospital of Jilin University, Changchun

188820

SPHI Leningrad Regional Psychoneurological Dispensary, Pgt. Roshchino

191025

LLC Medical Technologies, Saint Petersburg

191040

SPHI Leningrad Regional Psychoneurological Dispensary, Saint Petersburg

192019

FSBI V.M. Bekhterev National Research Medical Center, Saint Petersburg

192148

LLC Medical Technologies, Saint Petersburg

195112

SBHI of Saint Petersburg Psychoneurological Dispensary #5, Saint Petersburg

195176

SBHI of Saint Petersburg Psychoneurological Dispensary #5, Saint Petersburg

201100

Shanghai Huashan Hospital, Shanghai

201102

Children's Hospital of Fudan University, Shanghai

210015

UZ Vitebsk Regional Childrens Clinical Centre, Vitebsk

210022

UZ Vitebsk Regional Childrens Clinical Centre, Vitebsk

214018

Regional State Budgetary Institution of Ministry of Health, Smolensk

RSBHI Smolensk Regional Clinical Hospital, Smolensk

214019

"GBOU VPO Smolensk State Medical University", Smolensk

220053

GU Republican Scientific and Practical Center Mother and Child, Minsk

229899

KK Women's and Children's Hospital, Singapore

300314

Centrul Medical Dr. Bacos Cosma, Timișoara

357538

State Budgetary Healthcare Institution of Stavropol region, Pyatigorsk

440012

Getwell Hospital and Research Institute, Dhantoli, Nagpur

575003

Mangala Hospital & Mangala Kidney Foundation, Mangalore

603159

Nizhmedklinika, Nizhny Novgorod

614000

Perm State Medical University n. a. acad. E.A. Vagner, Perm

614990

Perm State Medical University n. a. acad. E.A. Vagner, Perm

620134

MAI Children's City Clinical Hospital No 9, Yekaterinburg

656045

TSBHI City Hospital No. 5 of Barnaul, Barnaul

700309

"Spitalul Clinic de Urgente pentru Copii Sf. Maria", Iași

3104802

Bnai Zion Medical Center, Haifa

6423906

Pharmacy of Tel Aviv Sourasky Medical Center, Tel Aviv

Tel Aviv Sourasky Medical Center, Tel Aviv

08901

Saint Peter's University Hospital, New Brunswick

613 00

Fakultni nemocnice Brno - Detska nemocnice, Brno - Cerna Pole

150 06

Fakultni nemocnice v Motole, Prague

07747

Universitaetsklinikum Jena, Jena

H-2660

Dr. Kenessey Albert Kórház és Rendelőintézet, Balassagyarmat

H-1023

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak, Budapest

H-1032

Szent Margit Korhaz, Budapest

H-1089

Heim Pal Gyermekkorhaz, Neurologiai Osztaly, Budapest

H-1146

Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia, Budapest

411 011

KEM Hospital Research Centre, Pune

Unknown

American University of Beirut Medical Center, Beirut

Saint George Hospital - University Medical Center, Beirut

80-803

COPERNICUS Podmiot Leczniczy Sp z o.o., Gdansk

80-952

Klinika Neurologii Rozwojowej, Gdansk

40-123

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski, Katowice

40-650

Nzoz Novo Med, Katowice

25-316

Gabinet lekarski Neurologii I Leczenia padaczki, Kielce

31-223

"Niepubliczny Zaklad Opieki Zdrowotnej HIPOKRATES-II Sp. z o.o.", Krakow

20-090

Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie, Lublin

60-355

Katedra i Klinika Neurologii Wieku Rozwojowego, Poznan

21-040

"NZOZ IGNIS Dr. n. med. Alicja Lobinska", Świdnik

54-049

Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,, Wroclaw

022113

Spitalul clinic de copii Dr. Victor Gomoiu, Bucharest

041914

"Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia", Bucharest

550 082

Spitalul de Psihiatrie Dr. Ghe. Preda, Sibiu

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

120-752

Severance Hospital, Yonsei University Health System, Seoul

06100

Hacettepe University Medical Faculty, Ankara

04209

"Derzhavnyi zaklad Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam", Kyiv

B15 2FG

The Barberry National Centre for Mental Health, Birmingham

M6 8HD

Salford Royal NHS Foundation Trust, Salford

All Listed Sponsors
lead

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

NCT01463306 - A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures | Biotech Hunter | Biotech Hunter