A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
NCT ID: NCT01747915
Last Updated: 2021-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
219 participants
INTERVENTIONAL
2013-04-03
2019-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Study Drug Level 1
Pregabalin Dose Level 1
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Study Drug Level 2
Pregabalin Dose Level 2
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Placebo
Placebo
Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
Interventions
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Pregabalin Dose Level 1
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Pregabalin Dose Level 2
Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
Placebo
Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have at least 1 PGTC seizure in the 8 weeks prior to screening
* Must have a minimum of 3 PGTC seizures during the 8-week baseline phase and at least 1 PGTC in each 4-week period of the baseline phase
* Currently receiving adequate and stable dosage of 1 to 3 anti-epileptic treatments (stable within 28 days of screening)
* Signed informed consent and assent if a minor
* Ability to comply with daily seizure and dosing diary requirements and all study procedures
Exclusion Criteria
* Focal seizures (simple partial, complex partial, or partial becoming secondarily generalized)
* Status Epilepticus within 1 year prior to screening
* Lennox-Gastaut syndrome, infantile spasms, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome
* Seizures related to drugs, alcohol, or acute medical illness
* Any change in anti-epileptic treatment regimen (type of medication or dose; VNS alteration) within 28 days of the screening visit or during the baseline phase
* Progressive or potentially progressive structural CNS lesion or a progressive encephalopathy.
* Progressive inborn errors of metabolism.
5 Years
65 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Axcess Medical Research
Loxahatchee Groves, Florida, United States
Pediatric Epilepsy Center of Central Florida
Orlando, Florida, United States
Pediatric Neurology, PA
Orlando, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Chinmay K. Patel, D.O.
Hoffman Estates, Illinois, United States
St. Alexius Medical Center
Hoffman Estates, Illinois, United States
Ohio Clinical Research Partners, LLC
Canton, Ohio, United States
Road Runner Research, Ltd
San Antonio, Texas, United States
Scott & White Memorial Hospital and Clinic
Temple, Texas, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, United States
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
AKH Linz
Linz, , Austria
UZ Vitebsk Regional Childrens Clinical Centre
Vitebsk, , Belarus
UZ Vitebsk Regional Childrens Clinical Centre
Vitebsk, , Belarus
University Clinical Center Sarajevo
Sarajevo, Canton Sarajevo, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, Canton Tuzla, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, Herzegovinaneretva Canton, Bosnia and Herzegovina
Public Health Institution Hospital Dr Mladen Stojanovic
Prijedor, Republika Srpska, Bosnia and Herzegovina
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad, , Bulgaria
DCC Sv. Pantaleimon OOD
Pleven, , Bulgaria
Military Medical Academy - Multiprofile Hospital for Active Treatment
Pleven, , Bulgaria
MHAT Central Onco Hospital OOD
Plovdiv, , Bulgaria
Medical Center Teodora
Rousse, , Bulgaria
MHATNP Sveti Naum EAD
Sofia, , Bulgaria
UMHAT Aleksandrovska
Sofia, , Bulgaria
DCC Sveta Anna - Sofia
Sofia, , Bulgaria
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Shanghai Huashan Hospital, Neurology Department
Shanghai, Shanghai Municipality, China
University Hospital Center Split, Clinic for Neurology
Split, , Croatia
Aarhus University Hospital
Aarhus C, , Denmark
Odense University Hospital
Odense C, , Denmark
CHU d'Amiens - Picardie
Amiens, , France
CHRU de Rennes - Hôpital Pontchaillou
Rennes, , France
CHU d'Amiens Hopital Pontchaillou
Rennes, , France
Eginition Hospital
Athens, , Greece
Athens Medical Center
Athens, , Greece
General Children's Hospital Penteli
Athens, , Greece
University General Hospital of Thessaloniki "AHEPA"
Thessaloniki, , Greece
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
Budapest, , Hungary
Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
Hódmezővásárhely, , Hungary
Pest Megyei Flór Ferenc Kórhaz
Kistarcsa, , Hungary
St. John's Medical College Hospital
Bangalore, Karnataka, India
Mangala Hospital & Mangala Kidney Foundation
Mangalore, Karnataka, India
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, India
Getwell Hospital and Research Institute
Nagpur, Maharashtra, India
Sahyadri Speciality Hospital
Pune, Maharashtra, India
KEM Hospital Research Centre
Pune, Maharashtra, India
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India
Saint George Hospital - University Medical Center
Beirut, , Lebanon
Ain Wazein Medical Village
El Chouf, , Lebanon
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Pzu Neuron
Bijelo Polje, , Montenegro
Cebu Doctors' University Hospital
Cebu City, CEBU, Philippines
Perpetual Succour Hospital
Cebu City, CEBU, Philippines
Cebu Doctors' University Hospital, Rm Ph 7
Cebu City, , Philippines
Manila Doctors Hospital
Manila, , Philippines
Metropolitan Medical Center
Manila, , Philippines
University of Santo Tomas Hospital
Manila, , Philippines
St. Luke's Medical Center Cathedral Heights Building
Quezon City, , Philippines
COPERNICUS Podmiot Leczniczy Spzoo
Gdansk, , Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, , Poland
NZOZ Novo Med
Katowice, , Poland
Neuro-Care Gabriela Klodowska
Katowice, , Poland
NZOZ "HIPOKRATES II" Sp. z o.o.
Krakow, , Poland
Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
Lublin, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
NZOZ IGNIS dr n. med. Alicja Lobinska
Świdnik, , Poland
Lecznica Medyczna ''Zycie"
Warsaw, , Poland
Centrul Medical de Diagnostic si Tratament Ambulator Neomed
Brasov, , Romania
CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria
Bucharest, , Romania
Sapiens Medical Center
Bucharest, , Romania
Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
Iași, , Romania
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
Iași, , Romania
Spitalul de Psihiatrie "Dr. Gh. Preda"
Sibiu, , Romania
SPHI Leningrad Regional Psychoneurological Dispensary
Pgt. Roshchino, Leningradskaya Oblast', Russia
Nizhmedklinika
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Perm State Medical University n. a. acad. E.A. Vagner
Perm, Permskiy KRAY, Russia
State Budgetary Healthcare Institution of Stavropol region
Pyatigorsk, Stavropol Kray, Russia
GBOU VPO "Kazan State Medical University" of Roszdrav
Kazan', Tatarstan Republic, Russia
Republican clinical hospital
Kazan', Tatarstan Republic, Russia
TSBHI City Hospital No. 5 of Barnaul
Barnaul, , Russia
MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1
Chelyabinsk, , Russia
Non-state Healthcare Institution
Moscow, , Russia
LLC City Neurological Center "Sibneiromed"
Novosibirsk, , Russia
Perm State Medical University n. a. acad. E.A. Vagner
Perm, , Russia
SPHI Leningrad Regional Psychoneurological Dispensary
Saint Petersburg, , Russia
FSBI V.M. Bekhterev National Research Medical Center for
Saint Petersburg, , Russia
SBHI of Saint Petersburg Psychoneurological Dispensary #5
Saint Petersburg, , Russia
SBHI of Saint Petersburg Psychoneurological Dispensary #5
Saint Petersburg, , Russia
Regional State Budgetary Institution of Ministry of Health
Smolensk, , Russia
RSBHI Smolensk Regional Clinical Hospital
Smolensk, , Russia
GBOU VPO Smolensk State Medical University
Smolensk, , Russia
SHI "Central Clinical Medical Unit
Ulyanovsk, , Russia
SHI "Central Clinical Medical Unit
Ulyanovsk, , Russia
Institute for Child and Youth Healthcare of Vojvodina
Novi Sad, Vojvodina, Serbia
Institute for Mental Health
Belgrade, , Serbia
University Children's Hospital
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Nemocnica s poliklinikou Hlohovec, s.r.o.
Hlohovec, , Slovakia
Neurologicka ambulancia MUDr. Eva Gasparova
Hlohovec, , Slovakia
Keimyung University Dongsan Hospital
Daegu, Korea, South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University medical center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Marmara University Pendik Training and Research Hospital
Istanbul, UST Kaynarca/pendik, Turkey (Türkiye)
Eskisehir Osmangazi University Medical Faculty Department Of Neurology
Eskişehir, , Turkey (Türkiye)
Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları
Izmir, , Turkey (Türkiye)
Celal Bayar University School of Medicine, Neurology Department
Manisa, , Turkey (Türkiye)
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2"
S. Oleksandrivka, Komintern. R-N, Odeska OBL., Ukraine
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia No. 5"
Dnipro, , Ukraine
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
Dnipro, , Ukraine
Ivano-Frankivska oblasna dytiacha klinichna likarnia
Ivano-Frankivsk, , Ukraine
Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
Kharkiv, , Ukraine
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
Kharkiv, , Ukraine
Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z
Kyiv, , Ukraine
Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivska oblasna klinichna likarnia"
Lviv, , Ukraine
Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi
Odesa, , Ukraine
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,
Uzhhorod, , Ukraine
Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
Zaporizhzhia, , Ukraine
The Barberry National Centre for Mental Health
Birmingham, WEST Midlands, United Kingdom
Barts Health NHS Foundation Trust, The Royal London Hospital
London, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
ABMU Local Health Board, Morriston Hospital
Swansea, , United Kingdom
Countries
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References
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Driscoll J, Almas M, Gregorian G, Kyrychenko A, Makedonska I, Liu J, Patrick J, Scavone JM, Antinew J; 1105 Study Group. Pregabalin as adjunctive therapy in adult and pediatric patients with generalized tonic-clonic seizures: A randomized, placebo-controlled trial. Epilepsia Open. 2021 Jun;6(2):381-393. doi: 10.1002/epi4.12492. Epub 2021 May 16.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-023263-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A0081105
Identifier Type: -
Identifier Source: org_study_id
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