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
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
2 other identifiers
interventional
605
30 countries
148
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2012
Longer than P75 for phase_3
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
November 1, 2011
CompletedStudy Start
First participant enrolled
February 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2019
CompletedResults Posted
Study results publicly available
February 21, 2020
CompletedJanuary 20, 2021
January 1, 2020
7.5 years
October 17, 2011
January 31, 2020
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (17)
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.
Baseline (Day 1) up to 13 Months
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.
Baseline up to 12 Months
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.
Baseline up to 12 months
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).
Baseline (Day 1)
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).
Month 12
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.
Baseline up to 12 Months
Absolute Values for Body Height at Baseline
Baseline
Absolute Values for Body Height at Month 12
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.
Baseline up to 12 Months
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.
Baseline up to 12 Months
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.
Week 1
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.
Month 1
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.
Month 2
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.
Month 4
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.
Month 6
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.
Month 9
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.
Month 12/Early Termination
Secondary Outcomes (4)
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)
Baseline (Day 1), Post-baseline on Day 1 up to 12 Months
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)
Baseline (Day 1), Post-baseline up to 12 Months
Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task
Month 12
Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task
Month 12
Study Arms (1)
Open
EXPERIMENTALPregabalin open label flexible dose
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (151)
Center for Neurosciences
Tucson, Arizona, 85718, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Axcess Medical Research
Loxahatchee Groves, Florida, 33470, United States
Laszlo J. Mate, M.D., P.A.
North Palm Beach, Florida, 33408, United States
Pediatric Epilepsy Center Of Central Florida
Orlando, Florida, 32819, United States
Pediatric Neurology, PA
Orlando, Florida, 32819, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308, United States
Pediatric Epilepsy and Neurology Specialists, PA
Tampa, Florida, 33609, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, 46237, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
University of Louisville Physicians
Louisville, Kentucky, 40202, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Ohio Clinical Research Partners, LLC
Canton, Ohio, 44718, United States
The children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, 75230, United States
Road Runner Research, Ltd.
San Antonio, Texas, 78249, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057, United States
GU Republican Scientific and Practical Center Mother and Child
Minsk, 220053, Belarus
UZ Vitebsk Regional Childrens Clinical Centre
Vitebsk, 210015, Belarus
UZ Vitebsk Regional Childrens Clinical Centre
Vitebsk, 210022, Belarus
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Brussels Capital, 1020, Belgium
Hospital Erasme
Brussels, Brussels Capital, 1070, Belgium
UZ Brussel - Campus Jette - Pediatric Neurology
Brussels, Brussels Capital, 1090, Belgium
University Clinical Center Sarajevo
Sarajevo, Canton Sarajevo, Bosnia and Herzegovina, 71000, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, Herzegovina-neretva Canton, 88000, Bosnia and Herzegovina
Public Health Institution Hospital "Dr. Mladen Stojanovic"
Prijedor, Republika Srpska, 79101, Bosnia and Herzegovina
"Multiprofile Hospital for Active Treatment Puls" AD
Blagoevgrad, 2700, Bulgaria
UMHAT Dr. Georgi Stranski Ltd.
Pleven, 5800, Bulgaria
MHAT Central Onco Hospital OOD
Plovdiv, 4000, Bulgaria
UMHAT "Sveti Georgi" Ltd., Pediatric Clinic
Plovdiv, 4000, Bulgaria
MHATNP Sveti Naum EAD
Sofia, 1113, Bulgaria
DCC Sveta Anna - Sofia\ Neurological room
Sofia, 1784, Bulgaria
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
Shanghai Huashan Hospital
Shanghai, Shanghai Municipality, 201100, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Fakultni nemocnice Brno - Detska nemocnice
Brno - Cerna Pole, 613 00, Czechia
Fakultni nemocnice v Motole
Prague, 150 06, Czechia
Hopital Raymond Poincare
Garches, 92380, France
CHRU de Rennes - Hopital Pontchaillou
Rennes, 35033, France
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg, 67098, France
Universitaetsklinikum Jena
Jena, Thuringia, 07747, Germany
General Children's Hospital of Athens "P&A Kyriakou"
Athens, 11527, Greece
General Children's Hospital Penteli
Athens, 15236, Greece
Dr. Kenessey Albert Kórház és Rendelőintézet
Balassagyarmat, H-2660, Hungary
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/
Budapest, 1083, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, H-1023, Hungary
Szent Margit Korhaz
Budapest, H-1032, Hungary
Heim Pal Gyermekkorhaz, Neurologiai Osztaly
Budapest, H-1089, Hungary
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
Budapest, H-1146, Hungary
Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly
Kistarcsa, 2143, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7623, Hungary
Mangala Hospital & Mangala Kidney Foundation
Mangalore, Karnataka, 575003, India
Getwell Hospital and Research Institute
Dhantoli, Nagpur, Maharashtra, 440012, India
KEM Hospital Research Centre
Pune, Maharashtra, 411 011, India
Bnai Zion Medical Center
Haifa, 3104802, Israel
Pharmacy of Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia
Ancona, 60123, Italy
A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
Ancona, 60123, Italy
Azienda Ospedaliero-Universitaria Meyer
Florence, 50139, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
Pavia, 27100, Italy
American University of Beirut Medical Center
Beirut, Lebanon
Saint George Hospital - University Medical Center
Beirut, Lebanon
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30990, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Pzu Neuron
Bijelo Polje, 84000, Montenegro
Cebu Doctors' University Hospital
Cebu City, CEBU, 6000, Philippines
Perpetual Succour Hospital
Cebu City, 6000, Philippines
Philippine Children's Medical Center
Diliman, Quezon City, 1105, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
Metropolitan Medical Center
Manila, 1003, Philippines
University of Santo Tomas Hospital
Manila, 1008, Philippines
Capitol Medical Center Inc.
Quezon City, 1100, Philippines
St. Luke's Medical Center
Quezon City, 1102, Philippines
COPERNICUS Podmiot Leczniczy Sp z o.o.
Gdansk, 80-803, Poland
Klinika Neurologii Rozwojowej
Gdansk, 80-952, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
Katowice, 40-123, Poland
Nzoz Novo Med
Katowice, 40-650, Poland
Gabinet lekarski Neurologii I Leczenia padaczki
Kielce, 25-316, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o.
Krakow, 31-223, Poland
Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
Lublin, 20-090, Poland
Katedra i Klinika Neurologii Wieku Rozwojowego
Poznan, 60-355, Poland
NZOZ "IGNIS" Dr. n. med. Alicja Lobinska
Świdnik, 21-040, Poland
Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,
Wroclaw, 54-049, Poland
Spitalul clinic de copii Dr. Victor Gomoiu
Bucharest, 022113, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
Bucharest, 041914, Romania
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
Iași, 700309, Romania
Spitalul de Psihiatrie Dr. Ghe. Preda
Sibiu, 550 082, Romania
Centrul Medical Dr. Bacos Cosma
Timișoara, 300314, Romania
SPHI Leningrad Regional Psychoneurological Dispensary
Pgt. Roshchino, Leningradskaya Oblast', 188820, Russia
Nizhmedklinika
Nizhny Novgorod, Nizhny Novgorod Oblast, 603159, Russia
Perm State Medical University n. a. acad. E.A. Vagner
Perm, Permskiy KRAY, 614000, Russia
State Budgetary Healthcare Institution of Stavropol region
Pyatigorsk, Stavropol Kray, 357538, Russia
TSBHI City Hospital No. 5 of Barnaul
Barnaul, 656045, Russia
FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
Moscow, 117997, Russia
FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
Moscow, 125412, Russia
Non-state Healthcare Institution
Moscow, 129128, Russia
Perm State Medical University n. a. acad. E.A. Vagner
Perm, 614990, Russia
LLC Medical Technologies
Saint Petersburg, 191025, Russia
SPHI Leningrad Regional Psychoneurological Dispensary
Saint Petersburg, 191040, Russia
FSBI V.M. Bekhterev National Research Medical Center
Saint Petersburg, 192019, Russia
LLC Medical Technologies
Saint Petersburg, 192148, Russia
SBHI of Saint Petersburg Psychoneurological Dispensary #5
Saint Petersburg, 195112, Russia
SBHI of Saint Petersburg Psychoneurological Dispensary #5
Saint Petersburg, 195176, Russia
Regional State Budgetary Institution of Ministry of Health
Smolensk, 214018, Russia
RSBHI Smolensk Regional Clinical Hospital
Smolensk, 214018, Russia
GBOU VPO "Smolensk State Medical University"
Smolensk, 214019, Russia
MAI Children's City Clinical Hospital No 9
Yekaterinburg, 620134, Russia
Institute for Child and Youth Healthcare of Vojvodina
Novi Sad, Vojvodina, 21000, Serbia
Mother and Child Healthcare Institute Dr Vukan Cupic
Belgrade, 11000, Serbia
University Children's Hospital Belgrade
Belgrade, 11000, Serbia
Clinical Center of Kragujevac
Kragujevac, 34000, Serbia
National University Hospital
Singapore, 119074, Singapore
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Neurologicka ambulancia MUDr. Eva Gasparova
Hlohovec, 92001, Slovakia
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Kaohsiung City, 833, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Siriraj Hospital, Mahidol University, Faculty of Medicine
Bangkoknoi, Bangkok, 10700, Thailand
Phramongkutklao Hospital, Neurology Unit,
Ratchathevee, Bangkok, 10400, Thailand
Hacettepe University Medical Faculty
Ankara, Ankara/sihhiye, 06100, Turkey (Türkiye)
Ege University Medical Faculty Department of Pediatrics Health and Diseases,
Izmir, Bornova/izmir, 35100, Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine Farabi Hospital
Trabzon, Farabi, 61080, Turkey (Türkiye)
Izmir Tepecik Training and Research Hospital
Izmir, Konak Turkey, 35120, Turkey (Türkiye)
Behcet Uz Children Disease and Surgery Training and Research Hospital
Izmir, Konak, 35210, Turkey (Türkiye)
Eskisehir Osmangazi University Medical Faculty
Eskişehir, Meselik Campus, 26480, Turkey (Türkiye)
Dokuz Eylül University medical Faculty Internal Medicine Disease
Izmir, 34340, Turkey (Türkiye)
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
Dnipro, 49027, Ukraine
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
Dnipropetrovsk, 49100, Ukraine
Ivano-Frankivska oblasna dytiacha klinichna likarnia
Ivano-Frankivsk, 76018, Ukraine
Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
Kharkiv, 61068, Ukraine
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
Kharkiv, 61068, Ukraine
Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
Kyiv, 04209, Ukraine
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv
Lviv, 79010, Ukraine
Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"
Odesa, 65006, Ukraine
Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"
Odesa, 65006, Ukraine
KU "Odeska oblasna dytiacha klinichna likarnia"
Odesa, 65031, Ukraine
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"
S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl., 67513, Ukraine
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2
Uzhhorod, 88018, Ukraine
Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
Zaporizhzhia, 69068, Ukraine
The Barberry National Centre for Mental Health
Birmingham, WEST Midlands, B15 2FG, United Kingdom
Salford Royal NHS Foundation Trust
Salford, M6 8HD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1 death occurred in reporting arm "Placebo-Previous to Pregabalin-Current" after participant completed the study and is captured in All-cause mortality section.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2011
First Posted
November 1, 2011
Study Start
February 21, 2012
Primary Completion
August 22, 2019
Study Completion
August 22, 2019
Last Updated
January 20, 2021
Results First Posted
February 21, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
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.