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

Primary Purpose

Partial Onset 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 Partial Onset Seizures focused on measuring Partial Onset Seizures, Epilepsy, Safety, Efficacy, Tolerability, Pregabalin, Lyrica, Adjunctive treatment, Placebo controlled, blinded, Eligibility Criteria

Eligibility Criteria

1 Month - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must have 3 partial onset seizures in the month prior to screening.
  • Subject must have 2 partial onset seizures during the 48 hour baseline phase.
  • Signed Informed Consent.
  • On 1-3 stable anti-epileptic drugs at screening.

Exclusion Criteria:

  • Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
  • Lennox-Gasteau, BECTS, and Dravet's syndrome.
  • Status epliepticus within 1 year of screening.
  • Any change in AED regimen with 7 days of screening.
  • Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
  • Progressive errors of metabolism.

Sites / Locations

  • Pediatric Epilepsy Center of Central Florida
  • Pediatric Neurology, PA
  • Pediatric Epilepsy & Neurology Specialists, PA
  • The University of Texas Health Science Center at Houston
  • Road Runner Research, Ltd.
  • GU Republican Scientific and Practical Center Mother and Child
  • UZ Brussel
  • University Clinical Centre of the Republic of Srpska
  • UMHAT Dr. Georgi Stranski Ltd.
  • UMHAT "Sveti Georgi" Ltd.
  • The First Bethune Hospital of Jilin University
  • Children's Hospital of Fudan University
  • Beijing Children's Hospital
  • Hopital Raymond Poincare
  • Universitaetsklinikum Jena
  • University General Hospital Attikon
  • General Hospital of Thessaloniki Ippokratio
  • Dr. Kenessey Albert Korhaz es Rendelointezet
  • Szent János Kórház es Észak Budai Egyesitett Kórházak
  • Szent Margit Kórház
  • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
  • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
  • Debreceni Egyetem Klinikai Központ
  • Pharmacy of The E. Wolfson Medical Center
  • The E. Wolfson Medical Center
  • Pharmacy of Tel Aviv Sourasky Medical Center
  • Tel Aviv Sourasky Medical Center
  • Seoul National University Hospital
  • Samsung Medical Center
  • American University of Beirut Medical Center
  • Saint George Hospital - University Medical Center
  • Hospital Raja Perempuan Zainab II
  • Cebu Doctors' University Hospital
  • Perpetual Succour Hospital
  • Manila Doctors Hospital
  • Metropolitan Medical Center
  • University of Santo Tomas Hospital
  • St. Luke's Medical Center
  • Philippine Children's Medical Center
  • Centrul Medical Unirea
  • Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
  • Nizhmedklinika
  • Perm State Medical University n. a. acad. E.A. Vagner
  • FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
  • FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
  • Perm State Medical University n. a. acad. E.A. Vagner
  • St. Petersburg State Pediatric Medical University
  • "Baltiyskaya Medicyna" LLC
  • LLC Medical Technologies
  • LLC Medical Technologies
  • RSBHI Smolensk Regional Clinical Hospital
  • SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev
  • SHI Central Clinical Medical Unit
  • SHI Central Clinical Medical Unit
  • MAI Children's City Clinical Hospital 9
  • Institute for Child and Youth Healthcare of Vojvodina
  • Mother and Child Healthcare Institute Dr Vukan Cupic
  • University Children's Hospital Belgrade
  • Hospital Universitario Miguel Servet
  • Chang Gung Memorial Hospital- Kaohsiung branch
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Siriraj Hospital, Faculty of Medicine, Mahidol University
  • Phramongkutklao Hospital
  • Izmir Tepecik Training and Research Hospital
  • Eskisehir Osmangazi Universitesi Tip Fakultesi
  • Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
  • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
  • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
  • Ivano-Frankivska oblasna dytiacha klinichna likarnia
  • DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
  • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2

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 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).

Secondary Outcome Measures

Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment.

Full Information

First Posted
February 25, 2014
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
NCT02072824
Brief Title
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
Official Title
A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2014 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 13, 2018 (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
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset 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
Partial Onset Seizures
Keywords
Partial Onset Seizures, Epilepsy, Safety, Efficacy, Tolerability, Pregabalin, Lyrica, Adjunctive treatment, Placebo controlled, blinded, Eligibility Criteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
175 (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
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Pregabalin Dose Level 2
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
Primary Outcome Measure Information:
Title
Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Description
All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).
Time Frame
Day 1 up to Day 14
Secondary Outcome Measure Information:
Title
Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase
Description
Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment.
Time Frame
Day 1 up to Day 14
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Time Frame
Day 1 up to End of study (EOS) (maximum Day 25)
Title
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.
Time Frame
Day 1 up to EOS (maximum Day 25)
Title
Number of Adverse Events by Severity
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.
Time Frame
Day 1 up to EOS (maximum Day 25)
Title
Number of Participants With Laboratory Test Abnormalities
Description
Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:<0.8*lower limit of normal[LLN],platelets:<0.5*LLN/>1.75*upper limit of normal[ULN]; leukocytes:<0.6*LLN/>1.5*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:<0.8*LLN/>1.2*ULN; basophils,eosinophils,monocytes:>1.2*ULN; prothrombin [PT],PT international ratio:>1.1*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:>0.3*ULN; bilirubin:>1.5*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:>1.3*ULN; sodium: <0.95*LLN/>1.05*ULN; potassium,chloride,calcium,bicarbonate:<0.9*LLN/>1.1*ULN; glucose fasting:<0.6*LLN/>1.5*ULN; creatine kinase:>2*ULN;urine glucose,ketone,protein:>=1;urine WBC,RBC:>= 20/High Power Field[HPF]; urine casts,hyaline casts:>1/Low Power Field; urine bacteria:>20/HPF.
Time Frame
From Baseline up to EOS (maximum Day 25)
Title
Number of Participants With Vital Signs Abnormalities
Description
Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.
Time Frame
From Baseline (BL) up to EOS (maximum Day 25)
Title
Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study
Description
Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion.
Time Frame
Screening and EOS (maximum Day 25)
Title
Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study
Description
Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure.
Time Frame
Baseline (BL) and EOS (maximum Day 25)
Title
Number of Participants With Electrocardiogram (ECG) Abnormalities
Description
Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal (maximum QTCB interval 450-<480 msec), were reported in this outcome measure.
Time Frame
From screening up to EOS (maximum Day 25)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have 3 partial onset seizures in the month prior to screening. Subject must have 2 partial onset seizures during the 48 hour baseline phase. Signed Informed Consent. On 1-3 stable anti-epileptic drugs at screening. Exclusion Criteria: Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms. Lennox-Gasteau, BECTS, and Dravet's syndrome. Status epliepticus within 1 year of screening. Any change in AED regimen with 7 days of screening. Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy. Progressive 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
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
Pediatric Epilepsy & Neurology Specialists, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Road Runner Research, Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
GU Republican Scientific and Practical Center Mother and Child
City
Minsk
ZIP/Postal Code
220053
Country
Belarus
Facility Name
UZ Brussel
City
Brussels
State/Province
Bruxelles Capitale
ZIP/Postal Code
1090
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
UMHAT Dr. Georgi Stranski Ltd.
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT "Sveti Georgi" Ltd.
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Facility Name
Beijing Children's Hospital
City
Beijing
ZIP/Postal Code
100045
Country
China
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Universitaetsklinikum Jena
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
University General Hospital Attikon
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
General Hospital of Thessaloniki Ippokratio
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Dr. Kenessey Albert Korhaz es Rendelointezet
City
Balassagyarmat
ZIP/Postal Code
H-2660
Country
Hungary
Facility Name
Szent János Kórház es Észak Budai Egyesitett Kórházak
City
Budapest
ZIP/Postal Code
H-1023
Country
Hungary
Facility Name
Szent Margit Kórház
City
Budapest
ZIP/Postal Code
H-1032
Country
Hungary
Facility Name
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
City
Budapest
ZIP/Postal Code
H-1146
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Pharmacy of The E. Wolfson Medical Center
City
Holon
ZIP/Postal Code
5810001
Country
Israel
Facility Name
The E. Wolfson Medical Center
City
Holon
ZIP/Postal Code
5810001
Country
Israel
Facility Name
Pharmacy of Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
Facility Name
Saint George Hospital - University Medical Center
City
Beirut
Country
Lebanon
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
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
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
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Philippine Children's Medical Center
City
Quezon City
ZIP/Postal Code
1105
Country
Philippines
Facility Name
Centrul Medical Unirea
City
Bucuresti
ZIP/Postal Code
013766
Country
Romania
Facility Name
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
City
Iasi
ZIP/Postal Code
700309
Country
Romania
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
FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
City
Moscow
ZIP/Postal Code
125412
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
St. Petersburg State Pediatric Medical University
City
Saint Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
"Baltiyskaya Medicyna" LLC
City
Saint Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
LLC Medical Technologies
City
Saint-Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
LLC Medical Technologies
City
Saint-Petersburg
ZIP/Postal Code
192148
Country
Russian Federation
Facility Name
RSBHI Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
SHI Ulyanovsk Regional Children's Clinical Hospital n. a. Y.F.Goryachev
City
Ulyanovsk
ZIP/Postal Code
432011
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
MAI Children's City Clinical Hospital 9
City
Yekaterinburg
ZIP/Postal Code
620134
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
Mother and Child Healthcare Institute Dr Vukan Cupic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Children's Hospital Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Chang Gung Memorial Hospital- Kaohsiung branch
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Siriraj Hospital, Faculty of Medicine, Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Ratchathevee
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Izmir Tepecik Training and Research Hospital
City
Izmir
State/Province
Konak
ZIP/Postal Code
35120
Country
Turkey
Facility Name
Eskisehir Osmangazi Universitesi Tip Fakultesi
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #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
DZ "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,viddilennia neirokhirurhii #2
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
32189338
Citation
Mann D, Antinew J, Knapp L, Almas M, Liu J, Scavone J, Yang R, Modequillo M, Makedonska I, Ortiz M, Kyrychenko A, Nordli D, Farkas V, Farkas MK; A0081042 study group. Pregabalin adjunctive therapy for focal onset seizures in children 1 month to <4 years of age: A double-blind, placebo-controlled, video-electroencephalographic trial. Epilepsia. 2020 Apr;61(4):617-626. doi: 10.1111/epi.16466. Epub 2020 Mar 18.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081042&StudyName=A%20Safety%2C%20Efficacy%2C%20and%20Tolerability%20Trial%20of%20Pregabalin%20as%20Add-On%20Treatment%20in%20Pediatric%20Subjects%20%3C4%20years%20of%20age%20with%20Partial%20
Description
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Learn more about this trial

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

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