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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.

Primary Purpose

Generalized Tonic Clonic Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin Dose Level 1
Pregabalin Dose Level 2
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Tonic Clonic Seizures focused on measuring Primary Generalized Tonic Clonic Seizures, Epilepsy, Safety, Efficacy, Tolerability, Pregabalin, Lyrica, Adjunctive treatment, Placebo Controlled, Blinded

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Axcess Medical Research
  • Pediatric Epilepsy Center of Central Florida
  • Pediatric Neurology, PA
  • Medsol Clinical Research Center
  • Hawaii Pacific Neuroscience
  • Alexian Brothers Center for Psychiatric Research
  • Chinmay K. Patel, D.O.
  • St. Alexius Medical Center
  • Ohio Clinical Research Partners, LLC
  • Road Runner Research, Ltd
  • Scott & White Memorial Hospital and Clinic
  • Rainier Clinical Research Center, Inc.
  • Medizinische Universitaet Innsbruck
  • AKH Linz
  • UZ Vitebsk Regional Childrens Clinical Centre
  • UZ Vitebsk Regional Childrens Clinical Centre
  • University Clinical Center Sarajevo
  • University Clinical Center Tuzla
  • University Clinical Hospital Mostar
  • Public Health Institution Hospital Dr Mladen Stojanovic
  • Multiprofile Hospital for Active Treatment Puls AD
  • DCC Sv. Pantaleimon OOD
  • Military Medical Academy - Multiprofile Hospital for Active Treatment
  • MHAT Central Onco Hospital OOD
  • Medical Center Teodora
  • MHATNP Sveti Naum EAD
  • UMHAT Aleksandrovska
  • DCC Sveta Anna - Sofia
  • The First Affiliated Hospital of Chongqing Medical University
  • The First Bethune Hospital of Jilin University
  • Shanghai Huashan Hospital, Neurology Department
  • University Hospital Center Split, Clinic for Neurology
  • Aarhus University Hospital
  • Odense University Hospital
  • CHU d'Amiens - Picardie
  • CHRU de Rennes - Hôpital Pontchaillou
  • CHU d'Amiens Hopital Pontchaillou
  • Eginition Hospital
  • Athens Medical Center
  • General Children's Hospital Penteli
  • University General Hospital of Thessaloniki "AHEPA"
  • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
  • Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
  • Pest Megyei Flór Ferenc Kórhaz
  • Indraprastha Apollo Hospitals
  • St. John's Medical College Hospital
  • Mangala Hospital & Mangala Kidney Foundation
  • P D Hinduja National Hospital and Medical Research Centre
  • Getwell Hospital and Research Institute
  • Sahyadri Speciality Hospital
  • KEM Hospital Research Centre
  • Keimyung University Dongsan Hospital
  • Seoul National University Hospital
  • Konkuk University medical center
  • Samsung Medical Center
  • Saint George Hospital - University Medical Center
  • Ain Wazein Medical Village
  • Hospital Raja Permaisuri Bainun
  • Pzu Neuron
  • Cebu Doctors' University Hospital
  • Perpetual Succour Hospital
  • Cebu Doctors' University Hospital, Rm Ph 7
  • Manila Doctors Hospital
  • Metropolitan Medical Center
  • University of Santo Tomas Hospital
  • St. Luke's Medical Center Cathedral Heights Building
  • COPERNICUS Podmiot Leczniczy Spzoo
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
  • NZOZ Novo Med
  • Neuro-Care Gabriela Klodowska
  • NZOZ "HIPOKRATES II" Sp. z o.o.
  • Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
  • Solumed Centrum Medyczne
  • NZOZ IGNIS dr n. med. Alicja Lobinska
  • Lecznica Medyczna ''Zycie"
  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed
  • CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria
  • Sapiens Medical Center
  • Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
  • Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
  • Spitalul de Psihiatrie "Dr. Gh. Preda"
  • SPHI Leningrad Regional Psychoneurological Dispensary
  • Nizhmedklinika
  • Perm State Medical University n. a. acad. E.A. Vagner
  • GBOU VPO "Kazan State Medical University" of Roszdrav
  • Republican clinical hospital
  • State Budgetary Healthcare Institution of Stavropol region
  • TSBHI City Hospital No. 5 of Barnaul
  • MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1
  • Non-state Healthcare Institution
  • LLC City Neurological Center "Sibneiromed"
  • Perm State Medical University n. a. acad. E.A. Vagner
  • FSBI V.M. Bekhterev National Research Medical Center for
  • SBHI of Saint Petersburg Psychoneurological Dispensary #5
  • SBHI of Saint Petersburg Psychoneurological Dispensary #5
  • SPHI Leningrad Regional Psychoneurological Dispensary
  • Regional State Budgetary Institution of Ministry of Health
  • RSBHI Smolensk Regional Clinical Hospital
  • GBOU VPO Smolensk State Medical University
  • SHI "Central Clinical Medical Unit
  • SHI "Central Clinical Medical Unit
  • Institute for Child and Youth Healthcare of Vojvodina
  • Institute for Mental Health
  • University Children's Hospital
  • Clinical Center Kragujevac
  • Nemocnica s poliklinikou Hlohovec, s.r.o.
  • Neurologicka ambulancia MUDr. Eva Gasparova
  • Hospital Universitari de Bellvitge
  • Marmara University Pendik Training and Research Hospital
  • Eskisehir Osmangazi University Medical Faculty Department Of Neurology
  • Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları
  • Celal Bayar University School of Medicine, Neurology Department
  • Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2"
  • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia No. 5"
  • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
  • Ivano-Frankivska oblasna dytiacha klinichna likarnia
  • Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
  • Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z
  • Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivska oblasna klinichna likarnia"
  • Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi
  • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,
  • Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
  • The Barberry National Centre for Mental Health
  • Barts Health NHS Foundation Trust, The Royal London Hospital
  • Salford Royal NHS Foundation Trust
  • ABMU Local Health Board, Morriston Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Study Drug Level 1

Study Drug Level 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).

Secondary Outcome Measures

Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase
Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28.

Full Information

First Posted
November 27, 2012
Last Updated
January 15, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01747915
Brief Title
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.
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 Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 3, 2013 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
February 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Tonic Clonic Seizures
Keywords
Primary Generalized Tonic Clonic Seizures, Epilepsy, Safety, Efficacy, Tolerability, Pregabalin, Lyrica, Adjunctive treatment, Placebo Controlled, Blinded

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Drug Level 1
Arm Type
Experimental
Arm Title
Study Drug Level 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin Dose Level 1
Other Intervention Name(s)
Lyrica Dose Level 1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin Dose Level 2
Other Intervention Name(s)
Lyrica Dose Level 2
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
Primary Outcome Measure Information:
Title
Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
Description
All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Time Frame
Day 1 up to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase
Description
Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28.
Time Frame
Day 1 up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Pediatric Epilepsy Center of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Pediatric Neurology, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Medsol Clinical Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Chinmay K. Patel, D.O.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
St. Alexius Medical Center
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Ohio Clinical Research Partners, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Road Runner Research, Ltd
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Scott & White Memorial Hospital and Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Rainier Clinical Research Center, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
AKH Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
UZ Vitebsk Regional Childrens Clinical Centre
City
Vitebsk
ZIP/Postal Code
210015
Country
Belarus
Facility Name
UZ Vitebsk Regional Childrens Clinical Centre
City
Vitebsk
ZIP/Postal Code
210022
Country
Belarus
Facility Name
University Clinical Center Sarajevo
City
Sarajevo
State/Province
Canton Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Tuzla
City
Tuzla
State/Province
Canton Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Hospital Mostar
City
Mostar
State/Province
Herzegovinaneretva Canton
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Public Health Institution Hospital Dr Mladen Stojanovic
City
Prijedor
State/Province
Republika Srpska
ZIP/Postal Code
79101
Country
Bosnia and Herzegovina
Facility Name
Multiprofile Hospital for Active Treatment Puls AD
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
DCC Sv. Pantaleimon OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Military Medical Academy - Multiprofile Hospital for Active Treatment
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHAT Central Onco Hospital OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Medical Center Teodora
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
MHATNP Sveti Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
UMHAT Aleksandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
DCC Sveta Anna - Sofia
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Shanghai Huashan Hospital, Neurology Department
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Facility Name
University Hospital Center Split, Clinic for Neurology
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU d'Amiens - Picardie
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
CHRU de Rennes - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU d'Amiens Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Eginition Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Athens Medical Center
City
Athens
ZIP/Postal Code
15125
Country
Greece
Facility Name
General Children's Hospital Penteli
City
Athens
ZIP/Postal Code
15236
Country
Greece
Facility Name
University General Hospital of Thessaloniki "AHEPA"
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
City
Hodmezovasarhely
ZIP/Postal Code
H-6800
Country
Hungary
Facility Name
Pest Megyei Flór Ferenc Kórhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
St. John's Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Mangala Hospital & Mangala Kidney Foundation
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Facility Name
P D Hinduja National Hospital and Medical Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400016
Country
India
Facility Name
Getwell Hospital and Research Institute
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Sahyadri Speciality Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
KEM Hospital Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
State/Province
Korea
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Konkuk University medical center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Saint George Hospital - University Medical Center
City
Beirut
ZIP/Postal Code
NAP
Country
Lebanon
Facility Name
Ain Wazein Medical Village
City
El Chouf
Country
Lebanon
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Pzu Neuron
City
Bijelo Polje
ZIP/Postal Code
84000
Country
Montenegro
Facility Name
Cebu Doctors' University Hospital
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Perpetual Succour Hospital
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Cebu Doctors' University Hospital, Rm Ph 7
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Metropolitan Medical Center
City
Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
University of Santo Tomas Hospital
City
Manila
ZIP/Postal Code
1008
Country
Philippines
Facility Name
St. Luke's Medical Center Cathedral Heights Building
City
Quezon City
Country
Philippines
Facility Name
COPERNICUS Podmiot Leczniczy Spzoo
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
NZOZ Novo Med
City
Katowice
ZIP/Postal Code
40-650
Country
Poland
Facility Name
Neuro-Care Gabriela Klodowska
City
Katowice
ZIP/Postal Code
40-749
Country
Poland
Facility Name
NZOZ "HIPOKRATES II" Sp. z o.o.
City
Krakow
ZIP/Postal Code
31-223
Country
Poland
Facility Name
Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Solumed Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
NZOZ IGNIS dr n. med. Alicja Lobinska
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Lecznica Medyczna ''Zycie"
City
Warsaw
ZIP/Postal Code
00-453
Country
Poland
Facility Name
Centrul Medical de Diagnostic si Tratament Ambulator Neomed
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria
City
Bucuresti
ZIP/Postal Code
010042
Country
Romania
Facility Name
Sapiens Medical Center
City
Bucuresti
ZIP/Postal Code
030583
Country
Romania
Facility Name
Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
City
Iasi
ZIP/Postal Code
700309
Country
Romania
Facility Name
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
City
Iasi
ZIP/Postal Code
700309
Country
Romania
Facility Name
Spitalul de Psihiatrie "Dr. Gh. Preda"
City
Sibiu
ZIP/Postal Code
550082
Country
Romania
Facility Name
SPHI Leningrad Regional Psychoneurological Dispensary
City
Pgt. Roshchino
State/Province
Leningrad Region
ZIP/Postal Code
188820
Country
Russian Federation
Facility Name
Nizhmedklinika
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603159
Country
Russian Federation
Facility Name
Perm State Medical University n. a. acad. E.A. Vagner
City
Perm
State/Province
Permskiy KRAY
ZIP/Postal Code
614000
Country
Russian Federation
Facility Name
GBOU VPO "Kazan State Medical University" of Roszdrav
City
Kazan
State/Province
Republic OF Tatarstan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Republican clinical hospital
City
Kazan
State/Province
Republic OF Tatarstan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Stavropol region
City
Pyatigorsk
State/Province
Stavropol Region
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
TSBHI City Hospital No. 5 of Barnaul
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Facility Name
Non-state Healthcare Institution
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
LLC City Neurological Center "Sibneiromed"
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Perm State Medical University n. a. acad. E.A. Vagner
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
FSBI V.M. Bekhterev National Research Medical Center for
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
SBHI of Saint Petersburg Psychoneurological Dispensary #5
City
Saint Petersburg
ZIP/Postal Code
195112
Country
Russian Federation
Facility Name
SBHI of Saint Petersburg Psychoneurological Dispensary #5
City
Saint Petersburg
ZIP/Postal Code
195176
Country
Russian Federation
Facility Name
SPHI Leningrad Regional Psychoneurological Dispensary
City
Saint-Petersburg
ZIP/Postal Code
191040
Country
Russian Federation
Facility Name
Regional State Budgetary Institution of Ministry of Health
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
RSBHI Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
GBOU VPO Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
SHI "Central Clinical Medical Unit
City
Ulyanovsk
ZIP/Postal Code
432026
Country
Russian Federation
Facility Name
SHI "Central Clinical Medical Unit
City
Ulyanovsk
ZIP/Postal Code
432045
Country
Russian Federation
Facility Name
Institute for Child and Youth Healthcare of Vojvodina
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Institute for Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Children's Hospital
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Nemocnica s poliklinikou Hlohovec, s.r.o.
City
Hlohovec
ZIP/Postal Code
92001
Country
Slovakia
Facility Name
Neurologicka ambulancia MUDr. Eva Gasparova
City
Hlohovec
ZIP/Postal Code
92001
Country
Slovakia
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
State/Province
UST Kaynarca/pendik
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Eskisehir Osmangazi University Medical Faculty Department Of Neurology
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Celal Bayar University School of Medicine, Neurology Department
City
Manisa
ZIP/Postal Code
45010
Country
Turkey
Facility Name
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2"
City
S. Oleksandrivka
State/Province
Komintern. R-N, Odeska OBL.
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia No. 5"
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
City
Dnipro
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Ivano-Frankivska oblasna dytiacha klinichna likarnia
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivska oblasna klinichna likarnia"
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
City
Zaporizhzhia
ZIP/Postal Code
69068
Country
Ukraine
Facility Name
The Barberry National Centre for Mental Health
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B15 2FG
Country
United Kingdom
Facility Name
Barts Health NHS Foundation Trust, The Royal London Hospital
City
London
ZIP/Postal Code
E1 2AT
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
ABMU Local Health Board, Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
34033265
Citation
Driscoll J, Almas M, Gregorian G, Kyrychenko A, Makedonska I, Liu J, Patrick J, Scavone JM, Antinew J; 1105 Study Group. Pregabalin as adjunctive therapy in adult and pediatric patients with generalized tonic-clonic seizures: A randomized, placebo-controlled trial. Epilepsia Open. 2021 Jun;6(2):381-393. doi: 10.1002/epi4.12492. Epub 2021 May 16.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081105&StudyName=A%20Safety%2C%20Efficacy%20and%20Tolerability%20Trial%20of%20Pregabalin%20as%20Add-On%20Treatment%20in%20Pediatric%20and%20Adult%20Subjects%20with%20Primary%20Generalized%20T
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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.

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