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.
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105
2 other identifiers
interventional
219
26 countries
127
Brief Summary
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2013
Longer than P75 for phase_3
127 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
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedStudy Start
First participant enrolled
April 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2019
CompletedResults Posted
Study results publicly available
August 28, 2019
CompletedJanuary 20, 2021
August 1, 2019
5.9 years
November 27, 2012
August 8, 2019
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase
All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= (\[number of seizures in the double blind treatment phase\] divided by \[number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase\])\*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Day 1 up to Week 12
Secondary Outcomes (1)
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase
Day 1 up to Week 12
Study Arms (3)
Study Drug Level 1
EXPERIMENTALStudy Drug Level 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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, 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, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
Eligibility Criteria
You may qualify if:
- Seizures classified as Primary Generalized Tonic Clonic Seizures
- 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
You may not qualify if:
- A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (127)
Axcess Medical Research
Loxahatchee Groves, Florida, 33470, United States
Pediatric Epilepsy Center of Central Florida
Orlando, Florida, 32819, United States
Pediatric Neurology, PA
Orlando, Florida, 32819, United States
Medsol Clinical Research Center
Port Charlotte, Florida, 33952, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Chinmay K. Patel, D.O.
Hoffman Estates, Illinois, 60169, United States
St. Alexius Medical Center
Hoffman Estates, Illinois, 60169, United States
Ohio Clinical Research Partners, LLC
Canton, Ohio, 44718, United States
Road Runner Research, Ltd
San Antonio, Texas, 78249, United States
Scott & White Memorial Hospital and Clinic
Temple, Texas, 76508, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057, United States
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
AKH Linz
Linz, 4021, Austria
UZ Vitebsk Regional Childrens Clinical Centre
Vitebsk, 210015, Belarus
UZ Vitebsk Regional Childrens Clinical Centre
Vitebsk, 210022, Belarus
University Clinical Center Sarajevo
Sarajevo, Canton Sarajevo, 71000, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, Canton Tuzla, 75000, Bosnia and Herzegovina
University Clinical Hospital Mostar
Mostar, Herzegovinaneretva 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
DCC Sv. Pantaleimon OOD
Pleven, 5800, Bulgaria
Military Medical Academy - Multiprofile Hospital for Active Treatment
Pleven, 5800, Bulgaria
MHAT Central Onco Hospital OOD
Plovdiv, 4000, Bulgaria
Medical Center Teodora
Rousse, 7000, Bulgaria
MHATNP Sveti Naum EAD
Sofia, 1113, Bulgaria
UMHAT Aleksandrovska
Sofia, 1431, Bulgaria
DCC Sveta Anna - Sofia
Sofia, 1784, Bulgaria
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
Shanghai Huashan Hospital, Neurology Department
Shanghai, Shanghai Municipality, 201100, China
University Hospital Center Split, Clinic for Neurology
Split, 21000, Croatia
Aarhus University Hospital
Aarhus C, 8000, Denmark
Odense University Hospital
Odense C, 5000, Denmark
CHU d'Amiens - Picardie
Amiens, 80054, France
CHRU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
CHU d'Amiens Hopital Pontchaillou
Rennes, 35033, France
Eginition Hospital
Athens, 11528, Greece
Athens Medical Center
Athens, 15125, Greece
General Children's Hospital Penteli
Athens, 15236, Greece
University General Hospital of Thessaloniki "AHEPA"
Thessaloniki, 54636, Greece
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
Budapest, H-1083, Hungary
Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
Hódmezővásárhely, H-6800, Hungary
Pest Megyei Flór Ferenc Kórhaz
Kistarcsa, 2143, Hungary
St. John's Medical College Hospital
Bangalore, Karnataka, 560034, India
Mangala Hospital & Mangala Kidney Foundation
Mangalore, Karnataka, 575003, India
P D Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016, India
Getwell Hospital and Research Institute
Nagpur, Maharashtra, 440012, India
Sahyadri Speciality Hospital
Pune, Maharashtra, 411004, India
KEM Hospital Research Centre
Pune, Maharashtra, 411011, India
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076, India
Saint George Hospital - University Medical Center
Beirut, NAP, Lebanon
Ain Wazein Medical Village
El Chouf, Lebanon
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30990, Malaysia
Pzu Neuron
Bijelo Polje, 84000, Montenegro
Cebu Doctors' University Hospital
Cebu City, CEBU, 6000, Philippines
Perpetual Succour Hospital
Cebu City, CEBU, 6000, Philippines
Cebu Doctors' University Hospital, Rm Ph 7
Cebu City, 6000, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
Metropolitan Medical Center
Manila, 1003, Philippines
University of Santo Tomas Hospital
Manila, 1008, Philippines
St. Luke's Medical Center Cathedral Heights Building
Quezon City, Philippines
COPERNICUS Podmiot Leczniczy Spzoo
Gdansk, 80-803, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, 40-123, Poland
NZOZ Novo Med
Katowice, 40-650, Poland
Neuro-Care Gabriela Klodowska
Katowice, 40-749, Poland
NZOZ "HIPOKRATES II" Sp. z o.o.
Krakow, 31-223, Poland
Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie
Lublin, 20-090, Poland
Solumed Centrum Medyczne
Poznan, 60-529, Poland
NZOZ IGNIS dr n. med. Alicja Lobinska
Świdnik, 21-040, Poland
Lecznica Medyczna ''Zycie"
Warsaw, 00-453, Poland
Centrul Medical de Diagnostic si Tratament Ambulator Neomed
Brasov, 500283, Romania
CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria
Bucharest, 010042, Romania
Sapiens Medical Center
Bucharest, 030583, Romania
Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
Iași, 700309, Romania
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
Iași, 700309, Romania
Spitalul de Psihiatrie "Dr. Gh. Preda"
Sibiu, 550082, 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
GBOU VPO "Kazan State Medical University" of Roszdrav
Kazan', Tatarstan Republic, 420012, Russia
Republican clinical hospital
Kazan', Tatarstan Republic, 420064, Russia
TSBHI City Hospital No. 5 of Barnaul
Barnaul, 656045, Russia
MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1
Chelyabinsk, 454048, Russia
Non-state Healthcare Institution
Moscow, 129128, Russia
LLC City Neurological Center "Sibneiromed"
Novosibirsk, 630091, Russia
Perm State Medical University n. a. acad. E.A. Vagner
Perm, 614990, Russia
SPHI Leningrad Regional Psychoneurological Dispensary
Saint Petersburg, 191040, Russia
FSBI V.M. Bekhterev National Research Medical Center for
Saint Petersburg, 192019, 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
SHI "Central Clinical Medical Unit
Ulyanovsk, 432026, Russia
SHI "Central Clinical Medical Unit
Ulyanovsk, 432045, Russia
Institute for Child and Youth Healthcare of Vojvodina
Novi Sad, Vojvodina, 21000, Serbia
Institute for Mental Health
Belgrade, 11000, Serbia
University Children's Hospital
Belgrade, 11000, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Nemocnica s poliklinikou Hlohovec, s.r.o.
Hlohovec, 92001, Slovakia
Neurologicka ambulancia MUDr. Eva Gasparova
Hlohovec, 92001, Slovakia
Keimyung University Dongsan Hospital
Daegu, Korea, 41931, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Konkuk University medical center
Seoul, 05030, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Marmara University Pendik Training and Research Hospital
Istanbul, UST Kaynarca/pendik, 34899, Turkey (Türkiye)
Eskisehir Osmangazi University Medical Faculty Department Of Neurology
Eskişehir, 26480, Turkey (Türkiye)
Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları
Izmir, 35340, Turkey (Türkiye)
Celal Bayar University School of Medicine, Neurology Department
Manisa, 45010, Turkey (Türkiye)
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2"
S. Oleksandrivka, Komintern. R-N, Odeska OBL., 67513, Ukraine
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia No. 5"
Dnipro, 49027, Ukraine
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
Dnipro, 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
Kyiv, 04209, Ukraine
Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivska oblasna klinichna likarnia"
Lviv, 79010, Ukraine
Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi
Odesa, 65006, Ukraine
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,
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
Barts Health NHS Foundation Trust, The Royal London Hospital
London, E1 2AT, United Kingdom
Salford Royal NHS Foundation Trust
Salford, M6 8HD, United Kingdom
ABMU Local Health Board, Morriston Hospital
Swansea, SA6 6NL, United Kingdom
Related Publications (1)
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.
PMID: 34033265DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
December 12, 2012
Study Start
April 3, 2013
Primary Completion
February 20, 2019
Study Completion
February 20, 2019
Last Updated
January 20, 2021
Results First Posted
August 28, 2019
Record last verified: 2019-08
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.