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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

Primary Purpose

Epilepsy, Partial Seizures, Epilepsy, Primary Generalized Tonic-Clonic Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin
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 Epilepsy, Partial Seizures focused on measuring safety, partial onset seizures, primary generalized tonic-clonic seizures, pregabalin, pediatric, adult, open-label, long term

Eligibility Criteria

1 Month - 66 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits.
  • Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit.
  • Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria.
  • Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening.
  • Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria:

  • Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome,
  • A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening.
  • Status epilepticus within 1 year prior to visit 1.
  • Seizures related to drugs, alcohol, or acute medical illness.
  • Progressive structural CNS lesion or a progressive encephalopathy.

Sites / Locations

  • Center for Neurosciences
  • Arkansas Children's Hospital
  • Children's Hospital Los Angeles
  • Axcess Medical Research
  • Laszlo J. Mate, M.D., P.A.
  • Pediatric Epilepsy Center Of Central Florida
  • Pediatric Neurology, PA
  • Tallahassee Neurological Clinic
  • Pediatric Epilepsy and Neurology Specialists, PA
  • Hawaii Pacific Neuroscience
  • Josephson Wallack Munshower Neurology P.C.
  • Kosair Children's Hospital
  • University of Louisville Physicians
  • Saint Peter's University Hospital
  • Akron Children's Hospital
  • Ohio Clinical Research Partners, LLC
  • The children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
  • Dallas Pediatric Neurology Associates
  • Road Runner Research, Ltd.
  • Rainier Clinical Research Center, Inc.
  • GU Republican Scientific and Practical Center Mother and Child
  • UZ Vitebsk Regional Childrens Clinical Centre
  • UZ Vitebsk Regional Childrens Clinical Centre
  • Hopital Universitaire Des Enfants Reine Fabiola
  • Hospital Erasme
  • UZ Brussel - Campus Jette - Pediatric Neurology
  • University Clinical Center Sarajevo
  • University Clinical Hospital Mostar
  • Public Health Institution Hospital "Dr. Mladen Stojanovic"
  • "Multiprofile Hospital for Active Treatment Puls" AD
  • UMHAT Dr. Georgi Stranski Ltd.
  • MHAT Central Onco Hospital OOD
  • UMHAT "Sveti Georgi" Ltd., Pediatric Clinic
  • MHATNP Sveti Naum EAD
  • DCC Sveta Anna - Sofia\ Neurological room
  • The First Bethune Hospital of Jilin University
  • Shanghai Huashan Hospital
  • Children's Hospital of Fudan University
  • Fakultni nemocnice Brno - Detska nemocnice
  • Fakultni nemocnice v Motole
  • Hopital Raymond Poincare
  • CHRU de Rennes - Hopital Pontchaillou
  • Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
  • Universitaetsklinikum Jena
  • General Children's Hospital of Athens "P&A Kyriakou"
  • General Children's Hospital Penteli
  • Dr. Kenessey Albert Kórház és Rendelőintézet
  • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  • Szent Margit Korhaz
  • Heim Pal Gyermekkorhaz, Neurologiai Osztaly
  • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
  • Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Mangala Hospital & Mangala Kidney Foundation
  • Getwell Hospital and Research Institute
  • KEM Hospital Research Centre
  • Bnai Zion Medical Center
  • Tel Aviv Sourasky Medical Center
  • Pharmacy of Tel Aviv Sourasky Medical Center
  • A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia
  • A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
  • Azienda Ospedaliero-Universitaria Meyer
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
  • Seoul National University Hospital
  • Samsung Medical Center
  • Severance Hospital, Yonsei University Health System
  • American University of Beirut Medical Center
  • Saint George Hospital - University Medical Center
  • Hospital Raja Perempuan Zainab II
  • Hospital Raja Permaisuri Bainun
  • Hospital Kuala Lumpur
  • Pzu Neuron
  • Cebu Doctors' University Hospital
  • Perpetual Succour Hospital
  • Philippine Children's Medical Center
  • Manila Doctors Hospital
  • Metropolitan Medical Center
  • University of Santo Tomas Hospital
  • Capitol Medical Center Inc.
  • St. Luke's Medical Center
  • COPERNICUS Podmiot Leczniczy Sp z o.o.
  • Klinika Neurologii Rozwojowej
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
  • Nzoz Novo Med
  • Gabinet lekarski Neurologii I Leczenia padaczki
  • Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o.
  • Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
  • Katedra i Klinika Neurologii Wieku Rozwojowego
  • NZOZ "IGNIS" Dr. n. med. Alicja Lobinska
  • Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,
  • Spitalul clinic de copii Dr. Victor Gomoiu
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
  • Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
  • Spitalul de Psihiatrie Dr. Ghe. Preda
  • Centrul Medical Dr. Bacos Cosma
  • SPHI Leningrad Regional Psychoneurological Dispensary
  • Nizhmedklinika
  • Perm State Medical University n. a. acad. E.A. Vagner
  • State Budgetary Healthcare Institution of Stavropol region
  • TSBHI City Hospital No. 5 of Barnaul
  • FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
  • FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
  • Non-state Healthcare Institution
  • Perm State Medical University n. a. acad. E.A. Vagner
  • FSBI V.M. Bekhterev National Research Medical Center
  • SBHI of Saint Petersburg Psychoneurological Dispensary #5
  • SBHI of Saint Petersburg Psychoneurological Dispensary #5
  • LLC Medical Technologies
  • SPHI Leningrad Regional Psychoneurological Dispensary
  • LLC Medical Technologies
  • Regional State Budgetary Institution of Ministry of Health
  • RSBHI Smolensk Regional Clinical Hospital
  • GBOU VPO "Smolensk State Medical University"
  • MAI Children's City Clinical Hospital No 9
  • Institute for Child and Youth Healthcare of Vojvodina
  • Mother and Child Healthcare Institute Dr Vukan Cupic
  • University Children's Hospital Belgrade
  • Clinical Center of Kragujevac
  • National University Hospital
  • KK Women's and Children's Hospital
  • Neurologicka ambulancia MUDr. Eva Gasparova
  • Hospital Universitario Miguel Servet
  • Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Siriraj Hospital, Mahidol University, Faculty of Medicine
  • Phramongkutklao Hospital, Neurology Unit,
  • Hacettepe University Medical Faculty
  • Ege University Medical Faculty Department of Pediatrics Health and Diseases,
  • Karadeniz Technical University Faculty of Medicine Farabi Hospital
  • Izmir Tepecik Training and Research Hospital
  • Behcet Uz Children Disease and Surgery Training and Research Hospital
  • Eskisehir Osmangazi University Medical Faculty
  • Dokuz Eylül University medical Faculty Internal Medicine Disease
  • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
  • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
  • 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 orhanichnym urazhenniam
  • Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv
  • Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"
  • Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"
  • KU "Odeska oblasna dytiacha klinichna likarnia"
  • Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"
  • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2
  • Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
  • The Barberry National Centre for Mental Health
  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open

Arm Description

Pregabalin open label flexible dose

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs
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 are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months
Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities
Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) >=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=20 mmHg.
Number of Participants With Tanner Staging Evaluation at Baseline
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Number of Participants With Tanner Staging Evaluation at Month 12
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months
In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported.
Absolute Values for Body Height at Baseline
Absolute Values for Body Height at Month 12
Number of Participants With Incidence of Laboratory Abnormalities
Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil- absolute/%:<0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte- absolute/%:>1.2*ULN; total/direct/indirect bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; thyroxine, thyroid stimulating hormone <0.8*LLN/>1.2*ULN; cholesterol, triglycerides:> >1.3*ULN; blood urea nitrogen, creatinine:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; glucose <0.6*LLN/>1.5*ULN, creatine kinase>2.0*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketones, protein: >=1, WBC, RBC:>=20, bacteria >20, hyaline casts/casts >1); prothrombin (PT), PT international ratio>1.1*ULN.
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters
Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond [msec]) percent change (PctChg) >=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change >=30 to <60; change >=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change >=30 to <60; change >=60. 'PctChg>=25/50%': >= 25% increase from baseline when baseline ECG parameter is > 200 msec, and is >= 50% increase from baseline when baseline ECG parameter is non-missing and <=200 msec.
28-Days Seizure Rate at Week 1
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
28-Days Seizure Rate at Month 1
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
28-Days Seizure Rate at Month 2
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
28-Days Seizure Rate at Month 4
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
28-Days Seizure Rate at Month 6
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
28-Days Seizure Rate at Month 9
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
28-Days Seizure Rate at Month 12/Early Termination
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.

Secondary Outcome Measures

Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)
Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with any methods (not plan) without intent to act", "active suicidal ideation with some intent to act, without specific plan", "active suicidal ideation with some intent to act, without specific plan".
Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)
Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of "Yes" on "actual attempt"); (3) preparatory acts toward imminent suicidal behavior ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior").
Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task
CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a "YES" response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI <=-1.65, decline in cognition when RCI =>1.65.
Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task
CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered "YES" if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI <=-1.65, decline in cognition: RCI =>1.65.

Full Information

First Posted
October 17, 2011
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
NCT01463306
Brief Title
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
Official Title
A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 21, 2012 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
August 22, 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
No

5. Study Description

Brief Summary
Study A0081106 is a 12-month open-label study to evaluate the long term 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. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial Seizures, Epilepsy, Primary Generalized Tonic-Clonic Seizures
Keywords
safety, partial onset seizures, primary generalized tonic-clonic seizures, pregabalin, pediatric, adult, open-label, long term

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
N/A
Enrollment
605 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open
Arm Type
Experimental
Arm Description
Pregabalin open label flexible dose
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related 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 are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
Time Frame
Baseline (Day 1) up to 13 Months
Title
Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months
Description
Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.
Time Frame
Baseline up to 12 Months
Title
Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities
Description
Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) >=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=20 mmHg.
Time Frame
Baseline up to 12 months
Title
Number of Participants With Tanner Staging Evaluation at Baseline
Description
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame
Baseline (Day 1)
Title
Number of Participants With Tanner Staging Evaluation at Month 12
Description
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
Time Frame
Month 12
Title
Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months
Description
In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported.
Time Frame
Baseline up to 12 Months
Title
Absolute Values for Body Height at Baseline
Time Frame
Baseline
Title
Absolute Values for Body Height at Month 12
Time Frame
Month 12
Title
Number of Participants With Incidence of Laboratory Abnormalities
Description
Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil- absolute/%:<0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte- absolute/%:>1.2*ULN; total/direct/indirect bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; thyroxine, thyroid stimulating hormone <0.8*LLN/>1.2*ULN; cholesterol, triglycerides:> >1.3*ULN; blood urea nitrogen, creatinine:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; glucose <0.6*LLN/>1.5*ULN, creatine kinase>2.0*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketones, protein: >=1, WBC, RBC:>=20, bacteria >20, hyaline casts/casts >1); prothrombin (PT), PT international ratio>1.1*ULN.
Time Frame
Baseline up to 12 Months
Title
Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters
Description
Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond [msec]) percent change (PctChg) >=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change >=30 to <60; change >=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change >=30 to <60; change >=60. 'PctChg>=25/50%': >= 25% increase from baseline when baseline ECG parameter is > 200 msec, and is >= 50% increase from baseline when baseline ECG parameter is non-missing and <=200 msec.
Time Frame
Baseline up to 12 Months
Title
28-Days Seizure Rate at Week 1
Description
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time Frame
Week 1
Title
28-Days Seizure Rate at Month 1
Description
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time Frame
Month 1
Title
28-Days Seizure Rate at Month 2
Description
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time Frame
Month 2
Title
28-Days Seizure Rate at Month 4
Description
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time Frame
Month 4
Title
28-Days Seizure Rate at Month 6
Description
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time Frame
Month 6
Title
28-Days Seizure Rate at Month 9
Description
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time Frame
Month 9
Title
28-Days Seizure Rate at Month 12/Early Termination
Description
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
Time Frame
Month 12/Early Termination
Secondary Outcome Measure Information:
Title
Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)
Description
Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with any methods (not plan) without intent to act", "active suicidal ideation with some intent to act, without specific plan", "active suicidal ideation with some intent to act, without specific plan".
Time Frame
Baseline (Day 1), Post-baseline on Day 1 up to 12 Months
Title
Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)
Description
Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of "Yes" on "actual attempt"); (3) preparatory acts toward imminent suicidal behavior ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior").
Time Frame
Baseline (Day 1), Post-baseline up to 12 Months
Title
Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task
Description
CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a "YES" response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI <=-1.65, decline in cognition when RCI =>1.65.
Time Frame
Month 12
Title
Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task
Description
CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded "yes" using a response button with dominant hand. Participants had to "respond as fast and as accurately as possible." Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered "YES" if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI <=-1.65, decline in cognition: RCI =>1.65.
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily dosing and seizure diaries and complete all scheduled visits. Male and female epilepsy subjects, 1 month to 65 years of age inclusive on the date of the Screening Visit. Diagnosis of epilepsy with seizures classified as simple partial, complex partial, or partial becoming secondarily generalized, or primary generalized tonic-clonic seizures according to the International League Against Epilepsy (ILAE 2010) Diagnosis Criteria. Partial onset seizure subjects must have had an average of at least 3 seizures per 28 day period in the 3 months prior to screening. Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening). Exclusion Criteria: Lennox-Gastaut syndrome, Infantile Spasms, Absence seizures, BECT (Benign Epilepsy with Centrotemporal Spikes), and Dravet syndrome, A current diagnosis of febrile seizures or any febrile seizure within 1 year of screening. Status epilepticus within 1 year prior to visit 1. Seizures related to drugs, alcohol, or acute medical illness. Progressive structural CNS lesion or a progressive encephalopathy.
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
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Laszlo J. Mate, M.D., P.A.
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
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
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Pediatric Epilepsy and Neurology Specialists, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Josephson Wallack Munshower Neurology P.C.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Physicians
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Ohio Clinical Research Partners, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Dallas Pediatric Neurology Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Road Runner Research, Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Rainier Clinical Research Center, Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
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 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
Hopital Universitaire Des Enfants Reine Fabiola
City
Brussels
State/Province
Brussels-capital
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Hospital Erasme
City
Brussels
State/Province
Brussels-capital
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Brussel - Campus Jette - Pediatric Neurology
City
Brussel
State/Province
Bruxelles Capitale
ZIP/Postal Code
1090
Country
Belgium
Facility Name
University Clinical Center Sarajevo
City
Sarajevo
State/Province
Canton Sarajevo, Bosnia AND Herzegovina
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Hospital Mostar
City
Mostar
State/Province
Herzegovina-neretva 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
UMHAT Dr. Georgi Stranski Ltd.
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
UMHAT "Sveti Georgi" Ltd., Pediatric Clinic
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHATNP Sveti Naum EAD
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
DCC Sveta Anna - Sofia\ Neurological room
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
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
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Facility Name
Fakultni nemocnice Brno - Detska nemocnice
City
Brno - Cerna Pole
ZIP/Postal Code
613 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Hopital Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
CHRU de Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Universitaetsklinikum Jena
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
General Children's Hospital of Athens "P&A Kyriakou"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Children's Hospital Penteli
City
Athens
ZIP/Postal Code
15236
Country
Greece
Facility Name
Dr. Kenessey Albert Kórház és Rendelőintézet
City
Balassagyarmat
ZIP/Postal Code
H-2660
Country
Hungary
Facility Name
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
City
Budapest
ZIP/Postal Code
H-1023
Country
Hungary
Facility Name
Szent Margit Korhaz
City
Budapest
ZIP/Postal Code
H-1032
Country
Hungary
Facility Name
Heim Pal Gyermekkorhaz, Neurologiai Osztaly
City
Budapest
ZIP/Postal Code
H-1089
Country
Hungary
Facility Name
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
City
Budapest
ZIP/Postal Code
H-1146
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Mangala Hospital & Mangala Kidney Foundation
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Facility Name
Getwell Hospital and Research Institute
City
Dhantoli, Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
KEM Hospital Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 011
Country
India
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3104802
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Pharmacy of Tel Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
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
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
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
Hospital Raja Permaisuri Bainun
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
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,
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Philippine Children's Medical Center
City
Diliman, Quezon City
ZIP/Postal Code
1105
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
Capitol Medical Center Inc.
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
COPERNICUS Podmiot Leczniczy Sp z o.o.
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Klinika Neurologii Rozwojowej
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
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
Gabinet lekarski Neurologii I Leczenia padaczki
City
Kielce
ZIP/Postal Code
25-316
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "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
Katedra i Klinika Neurologii Wieku Rozwojowego
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
NZOZ "IGNIS" Dr. n. med. Alicja Lobinska
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,
City
Wroclaw
ZIP/Postal Code
54-049
Country
Poland
Facility Name
Spitalul clinic de copii Dr. Victor Gomoiu
City
Bucuresti
ZIP/Postal Code
022113
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
City
Bucuresti
ZIP/Postal Code
041914
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. Ghe. Preda
City
Sibiu
ZIP/Postal Code
550 082
Country
Romania
Facility Name
Centrul Medical Dr. Bacos Cosma
City
Timisoara
ZIP/Postal Code
300314
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
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
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
Non-state Healthcare Institution
City
Moscow
ZIP/Postal Code
129128
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
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
LLC Medical Technologies
City
Saint-Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
SPHI Leningrad Regional Psychoneurological Dispensary
City
Saint-Petersburg
ZIP/Postal Code
191040
Country
Russian Federation
Facility Name
LLC Medical Technologies
City
Saint-Petersburg
ZIP/Postal Code
192148
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
MAI Children's City Clinical Hospital No 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
Clinical Center of Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
Neurologicka ambulancia MUDr. Eva Gasparova
City
Hlohovec
ZIP/Postal Code
92001
Country
Slovakia
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Chang Gung Memorial Hospital (CGMH) - 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, Mahidol University, Faculty of Medicine
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Phramongkutklao Hospital, Neurology Unit,
City
Ratchathevee, Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Hacettepe University Medical Faculty
City
Ankara
State/Province
Ankara/sihhiye
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ege University Medical Faculty Department of Pediatrics Health and Diseases,
City
Izmir
State/Province
Bornova/izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Karadeniz Technical University Faculty of Medicine Farabi Hospital
City
Trabzon
State/Province
Farabi
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Izmir Tepecik Training and Research Hospital
City
Izmir
State/Province
Konak Turkey
ZIP/Postal Code
35120
Country
Turkey
Facility Name
Behcet Uz Children Disease and Surgery Training and Research Hospital
City
Izmir
State/Province
Konak
ZIP/Postal Code
35210
Country
Turkey
Facility Name
Eskisehir Osmangazi University Medical Faculty
City
Eskisehir
State/Province
Meselik Campus
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Dokuz Eylül University medical Faculty Internal Medicine Disease
City
Izmir
ZIP/Postal Code
34340
Country
Turkey
Facility Name
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
City
Dnipropetrovsk
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
City
Dnipro
ZIP/Postal Code
49027
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 orhanichnym urazhenniam
City
Kyiv
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
KU "Odeska oblasna dytiacha klinichna likarnia"
City
Odesa
ZIP/Postal Code
65031
Country
Ukraine
Facility Name
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"
City
S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl.
ZIP/Postal Code
67513
Country
Ukraine
Facility Name
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2
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
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
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
Links:
URL
https://trialinfoemail.pfizer.com/pility%20Of%20Pregabages/landing.aspx?StudyID=A0081106
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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