Clinical trial NCT01463306: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-01
Enrollment: 605
Sex: ALL
Minimum age (years): 1
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs
timeFrame: Baseline (Day 1) up to 13 Months
measure: Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months
timeFrame: Baseline up to 12 Months
measure: Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities
timeFrame: Baseline up to 12 months
measure: Number of Participants With Tanner Staging Evaluation at Baseline
timeFrame: Baseline (Day 1)
measure: Number of Participants With Tanner Staging Evaluation at Month 12
timeFrame: Month 12
measure: Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months
timeFrame: Baseline up to 12 Months
measure: Absolute Values for Body Height at Baseline
timeFrame: Baseline
measure: Absolute Values for Body Height at Month 12
timeFrame: Month 12
measure: Number of Participants With Incidence of Laboratory Abnormalities
timeFrame: Baseline up to 12 Months
measure: Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters
timeFrame: Baseline up to 12 Months
measure: 28-Days Seizure Rate at Week 1
timeFrame: Week 1
measure: 28-Days Seizure Rate at Month 1
timeFrame: Month 1
measure: 28-Days Seizure Rate at Month 2
timeFrame: Month 2
measure: 28-Days Seizure Rate at Month 4
timeFrame: Month 4
measure: 28-Days Seizure Rate at Month 6
timeFrame: Month 6
measure: 28-Days Seizure Rate at Month 9
timeFrame: Month 9
measure: 28-Days Seizure Rate at Month 12/Early Termination
timeFrame: Month 12/Early Termination
Secondary outcomes:
measure: 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)
timeFrame: Baseline (Day 1), Post-baseline on Day 1 up to 12 Months
measure: 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)
timeFrame: Baseline (Day 1), Post-baseline up to 12 Months
measure: Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task
timeFrame: Month 12
measure: Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task
timeFrame: Month 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research
state: Florida
city: North Palm Beach
country: United States
facility: Laszlo J. Mate, M.D., P.A.
state: Florida
city: Orlando
country: United States
facility: Pediatric Epilepsy Center Of Central Florida
state: Florida
city: Orlando
country: United States
facility: Pediatric Neurology, PA
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Tampa
country: United States
facility: Pediatric Epilepsy and Neurology Specialists, PA
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology P.C.
state: Indiana
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Physicians
state: Kentucky
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Canton
country: United States
facility: Ohio Clinical Research Partners, LLC
state: Ohio
city: Philadelphia
country: United States
facility: The children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Pediatric Neurology Associates
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research, Ltd.
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
city: Minsk
country: Belarus
facility: GU Republican Scientific and Practical Center Mother and Child
city: Vitebsk
country: Belarus
facility: UZ Vitebsk Regional Childrens Clinical Centre
city: Vitebsk
country: Belarus
facility: UZ Vitebsk Regional Childrens Clinical Centre
city: Brussels
country: Belgium
facility: Hopital Universitaire Des Enfants Reine Fabiola
state: Brussels-capital
city: Brussels
country: Belgium
facility: Hospital Erasme
state: Brussels-capital
city: Brussel
country: Belgium
facility: UZ Brussel - Campus Jette - Pediatric Neurology
state: Bruxelles Capitale
city: Sarajevo
country: Bosnia and Herzegovina
facility: University Clinical Center Sarajevo
state: Canton Sarajevo, Bosnia AND Herzegovina
city: Mostar
country: Bosnia and Herzegovina
facility: University Clinical Hospital Mostar
state: Herzegovina-neretva Canton
city: Prijedor
country: Bosnia and Herzegovina
facility: Public Health Institution Hospital "Dr. Mladen Stojanovic"
state: Republika Srpska
city: Blagoevgrad
country: Bulgaria
facility: "Multiprofile Hospital for Active Treatment Puls" AD
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski Ltd.
city: Plovdiv
country: Bulgaria
facility: MHAT Central Onco Hospital OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT "Sveti Georgi" Ltd., Pediatric Clinic
city: Sofia
country: Bulgaria
facility: MHATNP Sveti Naum EAD
city: Sofia
country: Bulgaria
facility: DCC Sveta Anna - Sofia\ Neurological room
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Shanghai
country: China
facility: Shanghai Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Brno - Cerna Pole
country: Czechia
facility: Fakultni nemocnice Brno - Detska nemocnice
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Rennes
country: France
facility: CHRU de Rennes - Hopital Pontchaillou
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
state: Thueringen
city: Athens
country: Greece
facility: General Children's Hospital of Athens "P&A Kyriakou"
city: Athens
country: Greece
facility: General Children's Hospital Penteli
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Kórház és Rendelőintézet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika/
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
city: Budapest
country: Hungary
facility: Szent Margit Korhaz
city: Budapest
country: Hungary
facility: Heim Pal Gyermekkorhaz, Neurologiai Osztaly
city: Budapest
country: Hungary
facility: Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz, Neurologiai Osztaly
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Mangalore
country: India
facility: Mangala Hospital & Mangala Kidney Foundation
state: Karnataka
city: Dhantoli, Nagpur
country: India
facility: Getwell Hospital and Research Institute
state: Maharashtra
city: Pune
country: India
facility: KEM Hospital Research Centre
state: Maharashtra
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel-Aviv
country: Israel
facility: Pharmacy of Tel Aviv Sourasky Medical Center
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti di Ancona - Presidio Ospedaliero G. Salesi - S.O.D. Farmacia
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Meyer
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Saint George Hospital - University Medical Center
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Bijelo Polje
country: Montenegro
facility: Pzu Neuron
city: Cebu City
country: Philippines
facility: Cebu Doctors' University Hospital
state: Cebu
city: Cebu City,
country: Philippines
facility: Perpetual Succour Hospital
city: Diliman, Quezon City
country: Philippines
facility: Philippine Children's Medical Center
city: Manila,
country: Philippines
facility: Manila Doctors Hospital
city: Manila
country: Philippines
facility: Metropolitan Medical Center
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
city: Quezon City
country: Philippines
facility: Capitol Medical Center Inc.
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp z o.o.
city: Gdansk
country: Poland
facility: Klinika Neurologii Rozwojowej
city: Katowice
country: Poland
facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
city: Katowice
country: Poland
facility: Nzoz Novo Med
city: Kielce
country: Poland
facility: Gabinet lekarski Neurologii I Leczenia padaczki
city: Krakow
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "HIPOKRATES-II" Sp. z o.o.
city: Lublin
country: Poland
facility: Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
city: Poznan
country: Poland
facility: Katedra i Klinika Neurologii Wieku Rozwojowego
city: Swidnik
country: Poland
facility: NZOZ "IGNIS" Dr. n. med. Alicja Lobinska
city: Wroclaw
country: Poland
facility: Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka,
city: Bucuresti
country: Romania
facility: Spitalul clinic de copii Dr. Victor Gomoiu
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
city: Iasi
country: Romania
facility: Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
city: Sibiu
country: Romania
facility: Spitalul de Psihiatrie Dr. Ghe. Preda
city: Timisoara
country: Romania
facility: Centrul Medical Dr. Bacos Cosma
city: Pgt. Roshchino
country: Russian Federation
facility: SPHI Leningrad Regional Psychoneurological Dispensary
state: Leningrad Region
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhmedklinika
state: Nizhegorodskaya Oblast
city: Perm
country: Russian Federation
facility: Perm State Medical University n. a. acad. E.A. Vagner
state: Permskiy KRAY
city: Pyatigorsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Stavropol region
state: Stavropol Region
city: Barnaul
country: Russian Federation
facility: TSBHI City Hospital No. 5 of Barnaul
city: Moscow
country: Russian Federation
facility: FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
city: Moscow
country: Russian Federation
facility: FSFEI HE N.I. Pirogov RNRMU of Minzdrav of Russia
city: Moscow
country: Russian Federation
facility: Non-state Healthcare Institution
city: Perm
country: Russian Federation
facility: Perm State Medical University n. a. acad. E.A. Vagner
city: Saint Petersburg
country: Russian Federation
facility: FSBI V.M. Bekhterev National Research Medical Center
city: Saint Petersburg
country: Russian Federation
facility: SBHI of Saint Petersburg Psychoneurological Dispensary #5
city: Saint Petersburg
country: Russian Federation
facility: SBHI of Saint Petersburg Psychoneurological Dispensary #5
city: Saint-Petersburg
country: Russian Federation
facility: LLC Medical Technologies
city: Saint-Petersburg
country: Russian Federation
facility: SPHI Leningrad Regional Psychoneurological Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: LLC Medical Technologies
city: Smolensk
country: Russian Federation
facility: Regional State Budgetary Institution of Ministry of Health
city: Smolensk
country: Russian Federation
facility: RSBHI Smolensk Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: GBOU VPO "Smolensk State Medical University"
city: Yekaterinburg
country: Russian Federation
facility: MAI Children's City Clinical Hospital No 9
city: Novi Sad
country: Serbia
facility: Institute for Child and Youth Healthcare of Vojvodina
state: Vojvodina
city: Belgrade
country: Serbia
facility: Mother and Child Healthcare Institute Dr Vukan Cupic
city: Belgrade
country: Serbia
facility: University Children's Hospital Belgrade
city: Kragujevac
country: Serbia
facility: Clinical Center of Kragujevac
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Hlohovec
country: Slovakia
facility: Neurologicka ambulancia MUDr. Eva Gasparova
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Kaohsiung,
country: Taiwan
facility: Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital, Mahidol University, Faculty of Medicine
state: Bangkok
city: Ratchathevee, Bangkok
country: Thailand
facility: Phramongkutklao Hospital, Neurology Unit,
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
state: Ankara/sihhiye
city: Izmir
country: Turkey
facility: Ege University Medical Faculty Department of Pediatrics Health and Diseases,
state: Bornova/izmir
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Medicine Farabi Hospital
state: Farabi
city: Izmir
country: Turkey
facility: Izmir Tepecik Training and Research Hospital
state: Konak Turkey
city: Izmir
country: Turkey
facility: Behcet Uz Children Disease and Surgery Training and Research Hospital
state: Konak
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Medical Faculty
state: Meselik Campus
city: Izmir
country: Turkey
facility: Dokuz Eylül University medical Faculty Internal Medicine Disease
city: Dnipropetrovsk
country: Ukraine
facility: Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
city: Dnipro
country: Ukraine
facility: Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia #5"
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivska oblasna dytiacha klinichna likarnia
city: Kharkiv
country: Ukraine
facility: Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
city: Kharkiv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
city: Kyiv
country: Ukraine
facility: Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z orhanichnym urazhenniam
city: Lviv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia, Lv
city: Odesa
country: Ukraine
facility: Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia"
city: Odesa
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdoroviaa"
city: Odesa
country: Ukraine
facility: KU "Odeska oblasna dytiacha klinichna likarnia"
city: S. Oleksandrivka, Kominternivskyi R-n, Odeska Obl.
country: Ukraine
facility: Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia No2"
city: Uzhgorod
country: Ukraine
facility: Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii No2
city: Zaporizhzhia
country: Ukraine
facility: Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
city: Birmingham
country: United Kingdom
facility: The Barberry National Centre for Mental Health
state: WEST Midlands
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: