A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

PHASE3CompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

September 16, 2014

Primary Completion Date

March 13, 2018

Study Completion Date

March 13, 2018

Conditions
Partial Onset Seizures
Interventions
DRUG

Pregabalin Dose Level 1

Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase

DRUG

Pregabalin Dose Level 2

Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase

DRUG

Placebo

Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase

Trial Locations (72)

100

National Taiwan University Hospital, Taipei

833

Chang Gung Memorial Hospital- Kaohsiung branch, Kaohsiung City

1000

Manila Doctors Hospital, Manila

1003

Metropolitan Medical Center, Manila

1008

University of Santo Tomas Hospital, Manila

1090

UZ Brussel, Brussels

1102

St. Luke's Medical Center, Quezon City

1105

Philippine Children's Medical Center, Quezon City

4002

"UMHAT Sveti Georgi Ltd.", Plovdiv

5800

UMHAT Dr. Georgi Stranski Ltd., Pleven

6000

Cebu Doctors' University Hospital, Cebu City

Perpetual Succour Hospital, Cebu City

10400

Phramongkutklao Hospital, Ratchathevee

10700

Siriraj Hospital, Faculty of Medicine, Mahidol University, Bangkoknoi

11000

Mother and Child Healthcare Institute Dr Vukan Cupic, Belgrade

University Children's Hospital Belgrade, Belgrade

12462

University General Hospital Attikon, Athens

15586

Hospital Raja Perempuan Zainab II, Kota Bharu

21000

Institute for Child and Youth Healthcare of Vojvodina, Novi Sad

26480

Eskisehir Osmangazi Universitesi Tip Fakultesi, Eskişehir

32819

Pediatric Epilepsy Center of Central Florida, Orlando

Pediatric Neurology, PA, Orlando

33609

Pediatric Epilepsy & Neurology Specialists, PA, Tampa

35120

Izmir Tepecik Training and Research Hospital, Izmir

40447

China Medical University Hospital, Taichung

49027

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

49100

"Komunalnyi zaklad Dnipropetrovska oblasna dytiacha klinichna likarnia", Dnipro

50009

Hospital Universitario Miguel Servet, Zaragoza

54642

General Hospital of Thessaloniki Ippokratio, Thessaloniki

61080

Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi, Trabzon

76018

Ivano-Frankivska oblasna dytiacha klinichna likarnia, Ivano-Frankivsk

77030

The University of Texas Health Science Center at Houston, Houston

78000

University Clinical Centre of the Republic of Srpska, Banja Luka

78249

Road Runner Research, Ltd., San Antonio

88018

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2, Uzhhorod

92380

Hopital Raymond Poincare, Garches

100045

Beijing Children's Hospital, Beijing

117997

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

125412

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

130021

The First Bethune Hospital of Jilin University, Changchun

191025

LLC Medical Technologies, Saint Petersburg

192148

LLC Medical Technologies, Saint Petersburg

194100

St. Petersburg State Pediatric Medical University, Saint Petersburg

194356

"Baltiyskaya Medicyna LLC", Saint Petersburg

201102

Children's Hospital of Fudan University, Shanghai

214018

RSBHI Smolensk Regional Clinical Hospital, Smolensk

220053

GU Republican Scientific and Practical Center Mother and Child, Minsk

432011

SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev, Ulyanovsk

432026

SHI Central Clinical Medical Unit, Ulyanovsk

432045

SHI Central Clinical Medical Unit, Ulyanovsk

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 9, Yekaterinburg

700309

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

5810001

Pharmacy of The E. Wolfson Medical Center, Holon

The E. Wolfson Medical Center, Holon

6423906

Pharmacy of Tel Aviv Sourasky Medical Center, Tel Aviv

Tel Aviv Sourasky Medical Center, Tel Aviv

07747

Universitaetsklinikum Jena, Jena

H-2660

Dr. Kenessey Albert Korhaz es Rendelointezet, Balassagyarmat

H-1023

Szent János Kórház es Észak Budai Egyesitett Kórházak, Budapest

H-1032

Szent Margit Kórház, Budapest

H-1083

Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika, Budapest

H-1146

Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia, Budapest

H-4032

Debreceni Egyetem Klinikai Központ, Debrecen

Unknown

American University of Beirut Medical Center, Beirut

Saint George Hospital - University Medical Center, Beirut

013766

Centrul Medical Unirea, Bucharest

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

04209

"DZ Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam", Kyiv

All Listed Sponsors
lead

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

INDUSTRY

NCT02072824 - A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures. | Biotech Hunter | Biotech Hunter