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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

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ClinicalTrials.gov Identifier: NCT01463306
Recruitment Status : Completed
First Posted : November 1, 2011
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Epilepsy, Partial Seizures Epilepsy, Primary Generalized Tonic-Clonic Seizures Drug: Pregabalin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 21, 2012
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019


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 Name: Lyrica




Primary Outcome Measures :
  1. SAE's (serious adverse event) and AE's (adverse events) [ Time Frame: continuously for up to one year ]
  2. Vital signs [ Time Frame: change from baseline will be assessed at 2, 6, 9 , and 12 months ]
  3. Physical exams to assess change from baseline for physical state of limbs, torso, and organs and Neurological exams to assess change from baseline for measures of peripheral and central nervous system function. [ Time Frame: change from baseline will be assessed at 6 and 12 months ]
  4. Clinical laboratory data (hematology , chemistry, urinalysis [ Time Frame: change from baseline will be assessed at 6 and 12 months ]
  5. Electrocardiograms [ Time Frame: change from baseline will be assessed at 12 months ]

Secondary Outcome Measures :
  1. Suicidality assessments [ Time Frame: every visit for up to 1 year ]
  2. Cognitive testing [ Time Frame: change from baseline will be assessed at 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 66 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463306


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Locations
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United States, Arizona
Center for Neurosciences
Tucson, Arizona, United States, 85718
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
United States, Florida
Axcess Medical Research
Loxahatchee Groves, Florida, United States, 33470
Laszlo J. Mate, M.D., P.A.
North Palm Beach, Florida, United States, 33408
Pediatric Epilepsy Center Of Central Florida
Orlando, Florida, United States, 32819
Pediatric Neurology, PA
Orlando, Florida, United States, 32819
Tallahassee Neurological Clinic
Tallahassee, Florida, United States, 32308
Pediatric Epilepsy and Neurology Specialists, PA
Tampa, Florida, United States, 33609
United States, Hawaii
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States, 96817
United States, Indiana
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
University of Louisville Physicians
Louisville, Kentucky, United States, 40202
United States, New Jersey
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Ohio Clinical Research Partners, LLC
Canton, Ohio, United States, 44718
United States, Pennsylvania
The children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Dallas Pediatric Neurology Associates
Dallas, Texas, United States, 75230
Road Runner Research, Ltd.
San Antonio, Texas, United States, 78249
United States, Washington
Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057
Belarus
GU Republican Scientific and Practical Center Mother and Child
Minsk, Belarus, 220053
UZ Vitebsk Regional Childrens Clinical Centre
Vitebsk, Belarus, 210015
UZ Vitebsk Regional Childrens Clinical Centre
Vitebsk, Belarus, 210022
Belgium
Hopital Universitaire Des Enfants Reine Fabiola
Brussels, Brussels-capital, Belgium, 1020
Hospital Erasme
Brussels, Brussels-capital, Belgium, 1070
UZ Brussel - Campus Jette - Pediatric Neurology
Brussel, Bruxelles Capitale, Belgium, 1090
Bosnia and Herzegovina
University Clinical Center Sarajevo
Sarajevo, Canton Sarajevo, Bosnia AND Herzegovina, Bosnia and Herzegovina, 71000
University Clinical Hospital Mostar
Mostar, Herzegovina-neretva Canton, Bosnia and Herzegovina, 88000
Public Health Institution Hospital "Dr. Mladen Stojanovic"
Prijedor, Republika Srpska, Bosnia and Herzegovina, 79101
Bulgaria
"Multiprofile Hospital for Active Treatment Puls" AD
Blagoevgrad, Bulgaria, 2700
UMHAT Dr. Georgi Stranski Ltd.
Pleven, Bulgaria, 5800
MHAT Central Onco Hospital OOD
Plovdiv, Bulgaria, 4000
UMHAT "Sveti Georgi" Ltd., Pediatric Clinic
Plovdiv, Bulgaria, 4000
MHATNP Sveti Naum EAD
Sofia, Bulgaria, 1113
DCC Sveta Anna - Sofia\ Neurological room
Sofia, Bulgaria, 1784
China, Jilin
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021
China, Shanghai
Shanghai Huashan Hospital
Shanghai, Shanghai, China, 201100
Children's Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Czechia
Fakultni nemocnice Brno - Detska nemocnice
Brno - Cerna Pole, Czechia, 613 00
Fakultni nemocnice v Motole
Praha 5, Czechia, 150 06
France
Hopital Raymond Poincare
Garches, France, 92380
CHRU de Rennes - Hopital Pontchaillou
Rennes, France, 35033
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg, France, 67098
Germany
Universitaetsklinikum Jena
Jena, Thueringen, Germany, 07747
Greece
General Children's Hospital of Athens "P&A Kyriakou"
Athens, Greece, 11527
General Children's Hospital Penteli
Athens, Greece, 15236
Hungary
Dr. Kenessey Albert Kórház és Rendelőintézet
Balassagyarmat, Hungary, H-2660
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/
Budapest, Hungary, 1083
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary, H-1023
Szent Margit Korhaz
Budapest, Hungary, H-1032
Heim Pal Gyermekkorhaz, Neurologiai Osztaly
Budapest, Hungary, H-1089
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
Budapest, Hungary, H-1146
Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly
Kistarcsa, Hungary, 2143
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, Hungary, 7623
India
Mangala Hospital & Mangala Kidney Foundation
Mangalore, Karnataka, India, 575003
Getwell Hospital and Research Institute
Dhantoli, Nagpur, Maharashtra, India, 440012
KEM Hospital Research Centre
Pune, Maharashtra, India, 411 011
Israel
Bnai Zion Medical Center
Haifa, Israel, 3104802
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Pharmacy of Tel Aviv Sourasky Medical Center
Tel-Aviv, Israel, 6423906
Italy
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
Ancona, Italy, 60123
Azienda Ospedaliero-Universitaria Meyer
Firenze, Italy, 50139
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
Pavia, Italy, 27100
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Saint George Hospital - University Medical Center
Beirut, Lebanon
Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia, 15586
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia, 30990
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Montenegro
Pzu Neuron
Bijelo Polje, Montenegro, 84000
Philippines
Cebu Doctors' University Hospital
Cebu City, Cebu, Philippines, 6000
Perpetual Succour Hospital
Cebu City, Cebu, Philippines, 6000
Philippine Children's Medical Center
Diliman, Quezon City, Philippines, 1105
Manila Doctors Hospital
Manila, Philippines, 1000
Metropolitan Medical Center
Manila, Philippines, 1003
University of Santo Tomas Hospital
Manila, Philippines, 1008
Capitol Medical Center Inc.
Quezon City, Philippines, 1100
St. Luke's Medical Center
Quezon City, Philippines, 1102
Poland
NZOZ "IGNIS" Dr. n. med. Alicja Lobinska
Swidnik, Lubelskie, Poland, 21-040
COPERNICUS Podmiot Leczniczy Sp z o.o.
Gdansk, Poland, 80-803
Klinika Neurologii Rozwojowej
Gdansk, Poland, 80-952
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
Katowice, Poland, 40-123
Nzoz Novo Med
Katowice, Poland, 40-650
Gabinet lekarski Neurologii I Leczenia padaczki
Kielce, Poland, 25-316
Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o.
Krakow, Poland, 31-223
Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
Lublin, Poland, 20-090
Katedra i Klinika Neurologii Wieku Rozwojowego
Poznan, Poland, 60-355
Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,
Wroclaw, Poland, 54-049
Romania
Spitalul clinic de copii Dr. Victor Gomoiu
Bucuresti, Romania, 022113
Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
Bucuresti, Romania, 041914
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
Iasi, Romania, 700309
Spitalul de Psihiatrie Dr. Ghe. Preda
Sibiu, Romania, 550 082
Centrul Medical Dr. Bacos Cosma
Timisoara, Romania, 300314
Russian Federation
SPHI Leningrad Regional Psychoneurological Dispensary
Pgt. Roshchino, Leningrad Region, Russian Federation, 188820
Nizhmedklinika
Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603159
Perm State Medical University n. a. acad. E.A. Vagner
Perm, Permskiy KRAY, Russian Federation, 614000
State Budgetary Healthcare Institution of Stavropol region
Pyatigorsk, Stavropol Region, Russian Federation, 357538
TSBHI City Hospital No. 5 of Barnaul
Barnaul, Russian Federation, 656045
FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
Moscow, Russian Federation, 117997
FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
Moscow, Russian Federation, 125412
Non-state Healthcare Institution
Moscow, Russian Federation, 129128
Perm State Medical University n. a. acad. E.A. Vagner
Perm, Russian Federation, 614990
FSBI V.M. Bekhterev National Research Medical Center
Saint Petersburg, Russian Federation, 192019
SBHI of Saint Petersburg Psychoneurological Dispensary #5
Saint Petersburg, Russian Federation, 195112
SBHI of Saint Petersburg Psychoneurological Dispensary #5
Saint Petersburg, Russian Federation, 195176
LLC Medical Technologies
Saint-Petersburg, Russian Federation, 191025
SPHI Leningrad Regional Psychoneurological Dispensary
Saint-Petersburg, Russian Federation, 191040
LLC Medical Technologies
Saint-Petersburg, Russian Federation, 192148
Regional State Budgetary Institution of Ministry of Health
Smolensk, Russian Federation, 214018
RSBHI Smolensk Regional Clinical Hospital
Smolensk, Russian Federation, 214018
GBOU VPO "Smolensk State Medical University"
Smolensk, Russian Federation, 214019
MAI Children's City Clinical Hospital No 9
Yekaterinburg, Russian Federation, 620134
Serbia
Institute for Child and Youth Healthcare of Vojvodina
Novi Sad, Vojvodina, Serbia, 21000
Mother and Child Healthcare Institute Dr Vukan Cupic
Belgrade, Serbia, 11000
University Children's Hospital Belgrade
Belgrade, Serbia, 11000
Clinical Center of Kragujevac
Kragujevac, Serbia, 34000
Singapore
National University Hospital
Singapore, Singapore, 119074
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Slovakia
Neurologicka ambulancia MUDr. Eva Gasparova
Hlohovec, Slovakia, 92001
Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Taiwan
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Kaohsiung,, Taiwan, 833
China Medical University Hospital
Taichung, Taiwan, 40447
National Taiwan University Hospital
Taipei, Taiwan, 100
Thailand
2 Siriraj Hospital, Mahidol University, Faculty of Medicine
Bangkoknoi, Bangkok / Thailand, Thailand, 10700
Phramongkutklao Hospital, Neurology Unit,
Ratchathevee, Bangkok, Thailand, 10400
Turkey
Hacettepe University Medical Faculty
Ankara, Ankara/sihhiye, Turkey, 06100
Ege University Medical Faculty Department of Pediatrics Health and Diseases,
Izmir, Bornova/izmir, Turkey, 35100
Karadeniz Technical University Faculty of Medicine Farabi Hospital
Trabzon, Farabi, Turkey, 61080
Izmir Tepecik Training and Research Hospital
Izmir, Konak Turkey, Turkey, 35120
Behcet Uz Children Disease and Surgery Training and Research Hospital
Izmir, Konak, Turkey, 35210
Eskisehir Osmangazi University Medical Faculty
Eskisehir, Meselik Campus, Turkey, 26480
Dokuz Eylül University medical Faculty Internal Medicine Disease
Izmir, Narlidere, Turkey, 35340
Ukraine
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
Dnipropetrovsk, Ukraine, 49100
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
Dnipro, Ukraine, 49027
Ivano-Frankivska oblasna dytiacha klinichna likarnia
Ivano-Frankivsk, Ukraine, 76018
Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
Kharkiv, Ukraine, 61068
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
Kharkiv, Ukraine, 61068
Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
Kyiv, Ukraine, 04209
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv
Lviv, Ukraine, 79010
Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"
Odesa, Ukraine, 65006
Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"
Odesa, Ukraine, 65006
KU "Odeska oblasna dytiacha klinichna likarnia"
Odesa, Ukraine, 65031
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"
S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl., Ukraine, 67513
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2
Uzhgorod, Ukraine, 88018
Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
Zaporizhzhia, Ukraine, 69068
United Kingdom
The Barberry National Centre for Mental Health
Birmingham, WEST Midlands, United Kingdom, B15 2FG
Salford Royal NHS Foundation Trust
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01463306     History of Changes
Other Study ID Numbers: A0081106
2011-001412-65 ( EudraCT Number )
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
safety
partial onset seizures
primary generalized tonic-clonic seizures
pregabalin
pediatric
adult
open-label
long term
Additional relevant MeSH terms:
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Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs