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.

PHASE3CompletedINTERVENTIONAL
Enrollment

219

Participants

Timeline

Start Date

April 3, 2013

Primary Completion Date

February 20, 2019

Study Completion Date

February 20, 2019

Conditions
Generalized Tonic Clonic Seizures
Interventions
DRUG

Pregabalin Dose Level 1

Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.

DRUG

Pregabalin Dose Level 2

Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.

DRUG

Placebo

Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.

Trial Locations (127)

1000

Manila Doctors Hospital, Manila

1003

Metropolitan Medical Center, Manila

1008

University of Santo Tomas Hospital, Manila

1113

MHATNP Sveti Naum EAD, Sofia

1431

UMHAT Aleksandrovska, Sofia

1784

DCC Sveta Anna - Sofia, Sofia

2143

Pest Megyei Flór Ferenc Kórhaz, Kistarcsa

2700

Multiprofile Hospital for Active Treatment Puls AD, Blagoevgrad

4000

MHAT Central Onco Hospital OOD, Plovdiv

4021

AKH Linz, Linz

5000

Odense University Hospital, Odense C

5800

DCC Sv. Pantaleimon OOD, Pleven

Military Medical Academy - Multiprofile Hospital for Active Treatment, Pleven

6000

Cebu Doctors' University Hospital, Cebu City

Perpetual Succour Hospital, Cebu City

Cebu Doctors' University Hospital, Rm Ph 7, Cebu City

6020

Medizinische Universitaet Innsbruck, Innsbruck

7000

Medical Center Teodora, Rousse

8000

Aarhus University Hospital, Aarhus C

11000

Institute for Mental Health, Belgrade

University Children's Hospital, Belgrade

11528

Eginition Hospital, Athens

15125

Athens Medical Center, Athens

15236

General Children's Hospital Penteli, Athens

21000

University Hospital Center Split, Clinic for Neurology, Split

Institute for Child and Youth Healthcare of Vojvodina, Novi Sad

26480

Eskisehir Osmangazi University Medical Faculty Department Of Neurology, Eskişehir

30990

Hospital Raja Permaisuri Bainun, Ipoh

32819

Pediatric Epilepsy Center of Central Florida, Orlando

Pediatric Neurology, PA, Orlando

33470

Axcess Medical Research, Loxahatchee Groves

33952

Medsol Clinical Research Center, Port Charlotte

34000

Clinical Center Kragujevac, Kragujevac

34899

Marmara University Pendik Training and Research Hospital, Istanbul

35033

CHRU de Rennes - Hôpital Pontchaillou, Rennes

CHU d'Amiens Hopital Pontchaillou, Rennes

35340

Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları, Izmir

41931

Keimyung University Dongsan Hospital, Daegu

44718

Ohio Clinical Research Partners, LLC, Canton

45010

Celal Bayar University School of Medicine, Neurology Department, Manisa

49027

"Komunalnyi zaklad Dnipropetrovska dytiacha miska klinichna likarnia No. 5", Dnipro

49100

"Komunalnyi zaklad Dnipropetrovska oblasna dytiacha klinichna likarnia", Dnipro

54636

"University General Hospital of Thessaloniki AHEPA", Thessaloniki

60169

Alexian Brothers Center for Psychiatric Research, Hoffman Estates

Chinmay K. Patel, D.O., Hoffman Estates

St. Alexius Medical Center, Hoffman Estates

61068

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

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

65006

"Komunalne nekomertsiine pidpryiemstvo Odeskyi oblasnyi", Odesa

67513

"Komunalna ustanova Odeska oblasna psykhiatrychna likarnia 2", S. Oleksandrivka

69068

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

71000

University Clinical Center Sarajevo, Sarajevo

75000

University Clinical Center Tuzla, Tuzla

76018

Ivano-Frankivska oblasna dytiacha klinichna likarnia, Ivano-Frankivsk

76508

Scott & White Memorial Hospital and Clinic, Temple

78249

Road Runner Research, Ltd, San Antonio

79010

"Komunalnyi zaklad Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia", Lviv

79101

Public Health Institution Hospital Dr Mladen Stojanovic, Prijedor

80054

CHU d'Amiens - Picardie, Amiens

84000

Pzu Neuron, Bijelo Polje

88000

University Clinical Hospital Mostar, Mostar

88018

Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,, Uzhhorod

92001

Nemocnica s poliklinikou Hlohovec, s.r.o., Hlohovec

Neurologicka ambulancia MUDr. Eva Gasparova, Hlohovec

96817

Hawaii Pacific Neuroscience, Honolulu

98057

Rainier Clinical Research Center, Inc., Renton

110076

Indraprastha Apollo Hospitals, New Delhi

129128

Non-state Healthcare Institution, Moscow

130021

The First Bethune Hospital of Jilin University, Changchun

188820

SPHI Leningrad Regional Psychoneurological Dispensary, Pgt. Roshchino

191040

SPHI Leningrad Regional Psychoneurological Dispensary, Saint Petersburg

192019

FSBI V.M. Bekhterev National Research Medical Center for, 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, Neurology Department, 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

357538

State Budgetary Healthcare Institution of Stavropol region, Pyatigorsk

400016

The First Affiliated Hospital of Chongqing Medical University, Chongqing

P D Hinduja National Hospital and Medical Research Centre, Mumbai

411004

Sahyadri Speciality Hospital, Pune

411011

KEM Hospital Research Centre, Pune

420012

"GBOU VPO Kazan State Medical University of Roszdrav", Kazan'

420064

Republican clinical hospital, Kazan'

432026

"SHI Central Clinical Medical Unit", Ulyanovsk

432045

"SHI Central Clinical Medical Unit", Ulyanovsk

440012

Getwell Hospital and Research Institute, Nagpur

454048

MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1, Chelyabinsk

500283

Centrul Medical de Diagnostic si Tratament Ambulator Neomed, Brasov

550082

"Spitalul de Psihiatrie Dr. Gh. Preda", Sibiu

560034

St. John's Medical College Hospital, Bangalore

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

630091

"LLC City Neurological Center Sibneiromed", Novosibirsk

656045

TSBHI City Hospital No. 5 of Barnaul, Barnaul

700309

"Spitalul Clinic de Urgenta Prof. Dr. Nicolae Oblu", Iași

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

H-1083

Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika, Budapest

H-6800

Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako, Hódmezővásárhely

NAP

Saint George Hospital - University Medical Center, Beirut

Unknown

Ain Wazein Medical Village, El Chouf

St. Luke's Medical Center Cathedral Heights Building, Quezon City

80-803

COPERNICUS Podmiot Leczniczy Spzoo, Gdansk

40-123

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Katowice

40-650

NZOZ Novo Med, Katowice

40-749

Neuro-Care Gabriela Klodowska, Katowice

31-223

"NZOZ HIPOKRATES II Sp. z o.o.", Krakow

20-090

Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie, Lublin

60-529

Solumed Centrum Medyczne, Poznan

21-040

NZOZ IGNIS dr n. med. Alicja Lobinska, Świdnik

00-453

"Lecznica Medyczna ''Zycie", Warsaw

010042

CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria, Bucharest

030583

Sapiens Medical Center, Bucharest

03080

Seoul National University Hospital, Seoul

05030

Konkuk University medical center, Seoul

06351

Samsung Medical Center, Seoul

08907

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

04209

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

B15 2FG

The Barberry National Centre for Mental Health, Birmingham

E1 2AT

Barts Health NHS Foundation Trust, The Royal London Hospital, London

M6 8HD

Salford Royal NHS Foundation Trust, Salford

SA6 6NL

ABMU Local Health Board, Morriston Hospital, Swansea

All Listed Sponsors
lead

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

INDUSTRY

NCT01747915 - 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. | Biotech Hunter | Biotech Hunter