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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy, Partial Seizures; Epilepsy, Primary Generalized Tonic-Clonic Seizures
• Intervention / Treatment: Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 605
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus, 220053
    • GU Republican Scientific and Practical Center Mother and Child
  • Vitebsk, Belarus, 210015
    • UZ Vitebsk Regional Childrens Clinical Centre
  • Vitebsk, Belarus, 210022
    • UZ Vitebsk Regional Childrens Clinical Centre
• Belgium
  • Brussels-capital
    • Brussels, Brussels-capital, Belgium, 1020
      • Hôpital Universitaire Des Enfants Reine Fabiola
    • Brussels, Brussels-capital, Belgium, 1070
      • Hospital Erasme
  • Bruxelles Capitale
    • Brussel, Bruxelles Capitale, Belgium, 1090
      • UZ Brussel - Campus Jette - Pediatric Neurology
• Bosnia and Herzegovina
  • Canton Sarajevo, Bosnia AND Herzegovina
    • Sarajevo, Canton Sarajevo, Bosnia AND Herzegovina, Bosnia and Herzegovina, 71000
      • University Clinical Center Sarajevo
  • Herzegovina-neretva Canton
    • Mostar, Herzegovina-neretva Canton, Bosnia and Herzegovina, 88000
      • University Clinical Hospital Mostar
  • Republika Srpska
    • Prijedor, Republika Srpska, Bosnia and Herzegovina, 79101
      • Public Health Institution Hospital "Dr. Mladen Stojanovic"
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • "Multiprofile Hospital for Active Treatment Puls" AD
  • Pleven, Bulgaria, 5800
    • UMHAT Dr. Georgi Stranski Ltd.
  • Plovdiv, Bulgaria, 4000
    • MHAT Central Onco Hospital OOD
  • Plovdiv, Bulgaria, 4000
    • UMHAT "Sveti Georgi" Ltd., Pediatric Clinic
  • Sofia, Bulgaria, 1113
    • MHATNP Sveti Naum EAD
  • Sofia, Bulgaria, 1784
    • DCC Sveta Anna - Sofia\ Neurological room
• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin University
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University
    • Shanghai, Shanghai, China, 201100
      • Shanghai Huashan Hospital
• Czechia
  • Brno - Cerna Pole, Czechia, 613 00
    • Fakultní Nemocnice Brno - Dětská Nemocnice
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
• France
  • Garches, France, 92380
    • Hopital Raymond Poincare
  • Rennes, France, 35033
    • CHRU de Rennes - Hôpital Pontchaillou
  • Strasbourg, France, 67098
    • Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
• Germany
  • Thueringen
    • Jena, Thueringen, Germany, 07747
      • Universitaetsklinikum Jena
• Greece
  • Athens, Greece, 11527
    • General Children's Hospital of Athens "P&A Kyriakou"
  • Athens, Greece, 15236
    • General Children's Hospital Penteli
• Hungary
  • Balassagyarmat, Hungary, H-2660
    • Dr. Kenessey Albert Korhaz es Rendelointezet
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/
  • Budapest, Hungary, H-1023
    • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  • Budapest, Hungary, H-1032
    • Szent Margit Kórház
  • Budapest, Hungary, H-1089
    • Heim Pal Gyermekkorhaz, Neurologiai Osztaly
  • Budapest, Hungary, H-1146
    • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly
  • Pecs, Hungary, 7623
    • Pécsi Tudományegyetem Klinikai Központ
• India
  • Karnataka
    • Mangalore, Karnataka, India, 575003
      • Mangala Hospital & Mangala Kidney Foundation
  • Maharashtra
    • Dhantoli, Nagpur, Maharashtra, India, 440012
      • Getwell Hospital and Research Institute
    • Pune, Maharashtra, India, 411 011
      • KEM Hospital Research Centre
• Israel
  • Haifa, Israel, 3104802
    • Bnai Zion Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
  • Tel-Aviv, Israel, 6423906
    • Pharmacy of Tel Aviv Sourasky Medical Center
• Italy
  • Ancona, Italy, 60123
    • A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia
  • Ancona, Italy, 60123
    • A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
  • Firenze, Italy, 50139
    • Azienda Ospedaliero-Universitaria Meyer
  • Pavia, Italy, 27100
    • Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center
  • Beirut, Lebanon
    • Saint George Hospital - University Medical Center
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 15586
      • Hospital Raja Perempuan Zainab II
  • Perak
    • Ipoh, Perak, Malaysia, 30990
      • Hospital Raja Permaisuri Bainun
• Montenegro
  • Bijelo Polje, Montenegro, 84000
    • Pzu Neuron
• Philippines
  • Cebu City,, Philippines, 6000
    • Perpetual Succour Hospital
  • Diliman, Quezon City, Philippines, 1105
    • Philippine Children's Medical Center
  • Manila, Philippines, 1003
    • Metropolitan Medical Center
  • Manila, Philippines, 1008
    • University of Santo Tomas Hospital
  • Manila,, Philippines, 1000
    • Manila Doctors Hospital
  • Quezon City, Philippines, 1100
    • Capitol Medical Center Inc.
  • Quezon City, Philippines, 1102
    • St. Luke's Medical Center
  • Cebu
    • Cebu City, Cebu, Philippines, 6000
      • Cebu Doctors' University Hospital
• Poland
  • Gdansk, Poland, 80-803
    • COPERNICUS Podmiot Leczniczy Sp z o.o.
  • Gdansk, Poland, 80-952
    • Klinika Neurologii Rozwojowej
  • Katowice, Poland, 40-123
    • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
  • Katowice, Poland, 40-650
    • NZOZ Novo Med
  • Kielce, Poland, 25-316
    • Gabinet lekarski Neurologii I Leczenia padaczki
  • Krakow, Poland, 31-223
    • Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o.
  • Lublin, Poland, 20-090
    • Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
  • Poznan, Poland, 60-355
    • Katedra i Klinika Neurologii Wieku Rozwojowego
  • Swidnik, Poland, 21-040
    • NZOZ "IGNIS" Dr. n. med. Alicja Lobinska
  • Wroclaw, Poland, 54-049
    • Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,
• Romania
  • Bucuresti, Romania, 022113
    • Spitalul clinic de copii Dr. Victor Gomoiu
  • Bucuresti, Romania, 041914
    • Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
  • Iasi, Romania, 700309
    • Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
  • Sibiu, Romania, 550 082
    • Spitalul de Psihiatrie Dr. Ghe. Preda
  • Timisoara, Romania, 300314
    • Centrul Medical Dr. Bacos Cosma
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • TSBHI City Hospital No. 5 of Barnaul
  • Moscow, Russian Federation, 117997
    • FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
  • Moscow, Russian Federation, 125412
    • FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
  • Moscow, Russian Federation, 129128
    • Non-State Healthcare Institution
  • Perm, Russian Federation, 614990
    • Perm State Medical University n. a. acad. E.A. Vagner
  • Saint Petersburg, Russian Federation, 192019
    • FSBI V.M. Bekhterev National Research Medical Center
  • Saint Petersburg, Russian Federation, 195112
    • SBHI of Saint Petersburg Psychoneurological Dispensary #5
  • Saint Petersburg, Russian Federation, 195176
    • SBHI of Saint Petersburg Psychoneurological Dispensary #5
  • Saint-Petersburg, Russian Federation, 191025
    • LLC Medical Technologies
  • Saint-Petersburg, Russian Federation, 192148
    • LLC Medical Technologies
  • Saint-Petersburg, Russian Federation, 191040
    • SPHI Leningrad Regional Psychoneurological Dispensary
  • Smolensk, Russian Federation, 214018
    • Regional State Budgetary Institution of Ministry of Health
  • Smolensk, Russian Federation, 214018
    • RSBHI Smolensk Regional Clinical Hospital
  • Smolensk, Russian Federation, 214019
    • GBOU VPO "Smolensk State Medical University"
  • Yekaterinburg, Russian Federation, 620134
    • MAI Children's City Clinical Hospital No 9
  • Leningrad Region
    • Pgt. Roshchino, Leningrad Region, Russian Federation, 188820
      • SPHI Leningrad Regional Psychoneurological Dispensary
  • Nizhegorodskaya Oblast
    • Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603159
      • Nizhmedklinika
  • Permskiy KRAY
    • Perm, Permskiy KRAY, Russian Federation, 614000
      • Perm State Medical University n. a. acad. E.A. Vagner
  • Stavropol Region
    • Pyatigorsk, Stavropol Region, Russian Federation, 357538
      • State Budgetary Healthcare Institution of Stavropol region
• Serbia
  • Belgrade, Serbia, 11000
    • Mother and Child Healthcare Institute Dr Vukan Cupic
  • Belgrade, Serbia, 11000
    • University Children's Hospital Belgrade
  • Kragujevac, Serbia, 34000
    • Clinical Center of Kragujevac
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Institute for Child and Youth Healthcare of Vojvodina
• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
• Slovakia
  • Hlohovec, Slovakia, 92001
    • Neurologicka ambulancia MUDr. Eva Gasparova
• Spain
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• Taiwan
  • Kaohsiung,, Taiwan, 833
    • Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
• Thailand
  • Ratchathevee, Bangkok, Thailand, 10400
    • Phramongkutklao Hospital, Neurology Unit,
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Siriraj Hospital, Mahidol University, Faculty of Medicine
• Turkey
  • Izmir, Turkey, 34340
    • Dokuz Eylül University medical Faculty Internal Medicine Disease
  • Ankara/sihhiye
    • Ankara, Ankara/sihhiye, Turkey, 06100
      • Hacettepe University Medical Faculty
  • Bornova/izmir
    • Izmir, Bornova/izmir, Turkey, 35100
      • Ege University Medical Faculty Department of Pediatrics Health and Diseases,
  • Farabi
    • Trabzon, Farabi, Turkey, 61080
      • Karadeniz Technical University Faculty of Medicine Farabi Hospital
  • Konak
    • Izmir, Konak, Turkey, 35210
      • Behcet Uz Children Disease and surgery Training and research hospital
  • Konak Turkey
    • Izmir, Konak Turkey, Turkey, 35120
      • Izmir Tepecik Training and Research Hospital
  • Meselik Campus
    • Eskisehir, Meselik Campus, Turkey, 26480
      • Eskisehir Osmangazi University Medical Faculty
• Ukraine
  • Dnipro, Ukraine, 49027
    • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
  • Dnipropetrovsk, Ukraine, 49100
    • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
  • Ivano-Frankivsk, Ukraine, 76018
    • Ivano-Frankivska oblasna dytiacha klinichna likarnia
  • Kharkiv, Ukraine, 61068
    • Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
  • Kharkiv, Ukraine, 61068
    • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
  • Kyiv, Ukraine, 04209
    • Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
  • Lviv, Ukraine, 79010
    • Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv
  • Odesa, Ukraine, 65006
    • Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"
  • Odesa, Ukraine, 65006
    • Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"
  • Odesa, Ukraine, 65031
    • KU "Odeska oblasna dytiacha klinichna likarnia"
  • S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl., Ukraine, 67513
    • Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"
  • Uzhgorod, Ukraine, 88018
    • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2
  • Zaporizhzhia, Ukraine, 69068
    • Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
• United Kingdom
  • Salford, United Kingdom, M6 8HD
    • Salford Royal NHS Foundation Trust
  • WEST Midlands
    • Birmingham, WEST Midlands, United Kingdom, B15 2FG
      • The Barberry National Centre for Mental Health
• United States
  • Arizona
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
  • Florida
    • Loxahatchee Groves, Florida, United States, 33470
      • Axcess Medical Research
    • North Palm Beach, Florida, United States, 33408
      • Laszlo J. Mate, M.D., P.A.
    • Orlando, Florida, United States, 32819
      • Pediatric Neurology, PA
    • Orlando, Florida, United States, 32819
      • Pediatric Epilepsy Center of Central Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
    • Tampa, Florida, United States, 33609
      • Pediatric Epilepsy and Neurology Specialists, PA
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Josephson Wallack Munshower Neurology P.C.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kosair Children's Hospital
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Physicians
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital
    • Canton, Ohio, United States, 44718
      • Ohio Clinical Research Partners, LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Pediatric Neurology Associates
    • San Antonio, Texas, United States, 78249
      • Road Runner Research, Ltd.
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Open; Pregabalin open label flexible dose

Drug: Pregabalin; 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.; Other Names: Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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)	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").	Baseline (Day 1), Post-baseline up to 12 Months
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.	Month 12
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.	Month 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2012
• Primary Completion (Actual): August 22, 2019
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: October 28, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: adult; safety; pediatric; open-label; pregabalin; partial onset seizures; primary generalized tonic-clonic seizures; long term
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081106; 2011-001412-65 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No