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.
- Conditions
- Generalized Tonic Clonic Seizures
- Interventions
- Registration Number
- NCT01747915
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Drug Level 1 Pregabalin Dose Level 1 - Study Drug Level 2 Pregabalin Dose Level 2 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase Day 1 up to Week 12 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).
- Secondary Outcome Measures
Name Time Method 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 Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 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.
Trial Locations
- Locations (122)
University Clinical Center Sarajevo
🇧🇦Sarajevo, Canton Sarajevo, Bosnia and Herzegovina
University Clinical Hospital Mostar
🇧🇦Mostar, Herzegovinaneretva Canton, Bosnia and Herzegovina
Military Medical Academy - Multiprofile Hospital for Active Treatment
🇧🇬Pleven, Bulgaria
MHAT Central Onco Hospital OOD
🇧🇬Plovdiv, Bulgaria
MHATNP Sveti Naum EAD
🇧🇬Sofia, Bulgaria
UMHAT Aleksandrovska
🇧🇬Sofia, Bulgaria
Sahyadri Speciality Hospital
🇮🇳Pune, Maharashtra, India
Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
ðŸ‡ðŸ‡ºBudapest, Hungary
Getwell Hospital and Research Institute
🇮🇳Nagpur, Maharashtra, India
University Hospital Center Split, Clinic for Neurology
ðŸ‡ðŸ‡·Split, Croatia
Eginition Hospital
🇬🇷Athens, Greece
Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako
ðŸ‡ðŸ‡ºHodmezovasarhely, Hungary
St. John's Medical College Hospital
🇮🇳Bangalore, Karnataka, India
General Children's Hospital Penteli
🇬🇷Athens, Greece
University General Hospital of Thessaloniki "AHEPA"
🇬🇷Thessaloniki, Greece
Pest Megyei Flór Ferenc Kórhaz
ðŸ‡ðŸ‡ºKistarcsa, Hungary
Saint George Hospital - University Medical Center
🇱🇧Beirut, Lebanon
Ain Wazein Medical Village
🇱🇧El Chouf, Lebanon
P D Hinduja National Hospital and Medical Research Centre
🇮🇳Mumbai, Maharashtra, India
Centrul Medical de Diagnostic si Tratament Ambulator Neomed
🇷🇴Brasov, Romania
COPERNICUS Podmiot Leczniczy Spzoo
🇵🇱Gdansk, Poland
KEM Hospital Research Centre
🇮🇳Pune, Maharashtra, India
Lecznica Medyczna ''Zycie"
🇵🇱Warsaw, Poland
NZOZ IGNIS dr n. med. Alicja Lobinska
🇵🇱Swidnik, Poland
Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
🇷🇴Iasi, Romania
Perm State Medical University n. a. acad. E.A. Vagner
🇷🇺Perm, Russian Federation
FSBI V.M. Bekhterev National Research Medical Center for
🇷🇺Saint Petersburg, Russian Federation
State Budgetary Healthcare Institution of Stavropol region
🇷🇺Pyatigorsk, Stavropol Region, Russian Federation
TSBHI City Hospital No. 5 of Barnaul
🇷🇺Barnaul, Russian Federation
MAHI of the Order of the Red Banner of Labor City Clinical Hospital No. 1
🇷🇺Chelyabinsk, Russian Federation
LLC City Neurological Center "Sibneiromed"
🇷🇺Novosibirsk, Russian Federation
GBOU VPO Smolensk State Medical University
🇷🇺Smolensk, Russian Federation
CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria
🇷🇴Bucuresti, Romania
GBOU VPO "Kazan State Medical University" of Roszdrav
🇷🇺Kazan, Republic OF Tatarstan, Russian Federation
SBHI of Saint Petersburg Psychoneurological Dispensary #5
🇷🇺Saint Petersburg, Russian Federation
Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
🇺🇦Kharkiv, Ukraine
SHI "Central Clinical Medical Unit
🇷🇺Ulyanovsk, Russian Federation
Institute for Mental Health
🇷🇸Belgrade, Serbia
Nemocnica s poliklinikou Hlohovec, s.r.o.
🇸🇰Hlohovec, Slovakia
Komunalne nekomertsiine pidpryiemstvo "Odeskyi oblasnyi
🇺🇦Odesa, Ukraine
Neurologicka ambulancia MUDr. Eva Gasparova
🇸🇰Hlohovec, Slovakia
Axcess Medical Research
🇺🇸Loxahatchee Groves, Florida, United States
Pediatric Neurology, PA
🇺🇸Orlando, Florida, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Road Runner Research, Ltd
🇺🇸San Antonio, Texas, United States
Chinmay K. Patel, D.O.
🇺🇸Hoffman Estates, Illinois, United States
DCC Sv. Pantaleimon OOD
🇧🇬Pleven, Bulgaria
Athens Medical Center
🇬🇷Athens, Greece
Mangala Hospital & Mangala Kidney Foundation
🇮🇳Mangalore, Karnataka, India
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Konkuk University medical center
🇰🇷Seoul, Korea, Republic of
St. Luke's Medical Center Cathedral Heights Building
🇵ðŸ‡Quezon City, Philippines
Cebu Doctors' University Hospital
🇵ðŸ‡Cebu City, Cebu, Philippines
Manila Doctors Hospital
🇵ðŸ‡Manila, Philippines
Metropolitan Medical Center
🇵ðŸ‡Manila, Philippines
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
🇵🇱Katowice, Poland
Republican clinical hospital
🇷🇺Kazan, Republic OF Tatarstan, Russian Federation
Regional State Budgetary Institution of Ministry of Health
🇷🇺Smolensk, Russian Federation
RSBHI Smolensk Regional Clinical Hospital
🇷🇺Smolensk, Russian Federation
The Barberry National Centre for Mental Health
🇬🇧Birmingham, WEST Midlands, United Kingdom
Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia
🇺🇦Zaporizhzhia, Ukraine
ABMU Local Health Board, Morriston Hospital
🇬🇧Swansea, United Kingdom
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Odense University Hospital
🇩🇰Odense C, Denmark
DCC Sveta Anna - Sofia
🇧🇬Sofia, Bulgaria
CHU d'Amiens - Picardie
🇫🇷Amiens Cedex 1, France
Sapiens Medical Center
🇷🇴Bucuresti, Romania
UZ Vitebsk Regional Childrens Clinical Centre
🇧🇾Vitebsk, Belarus
Public Health Institution Hospital Dr Mladen Stojanovic
🇧🇦Prijedor, Republika Srpska, Bosnia and Herzegovina
Medical Center Teodora
🇧🇬Ruse, Bulgaria
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
AKH Linz
🇦🇹Linz, Austria
University Clinical Center Tuzla
🇧🇦Tuzla, Canton Tuzla, Bosnia and Herzegovina
Rainier Clinical Research Center, Inc.
🇺🇸Renton, Washington, United States
Multiprofile Hospital for Active Treatment Puls AD
🇧🇬Blagoevgrad, Bulgaria
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Aarhus University Hospital
🇩🇰Aarhus C, Denmark
CHRU de Rennes - Hôpital Pontchaillou
🇫🇷Rennes, France
CHU d'Amiens Hopital Pontchaillou
🇫🇷Rennes, France
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Korea, Republic of
Shanghai Huashan Hospital, Neurology Department
🇨🇳Shanghai, Shanghai, China
Indraprastha Apollo Hospitals
🇮🇳New Delhi, Delhi, India
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Pzu Neuron
🇲🇪Bijelo Polje, Montenegro
Cebu Doctors' University Hospital, Rm Ph 7
🇵ðŸ‡Cebu City, Philippines
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Perak, Malaysia
SPHI Leningrad Regional Psychoneurological Dispensary
🇷🇺Saint-Petersburg, Russian Federation
Nizhmedklinika
🇷🇺Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Non-state Healthcare Institution
🇷🇺Moscow, Russian Federation
Perpetual Succour Hospital
🇵ðŸ‡Cebu City, Cebu, Philippines
University of Santo Tomas Hospital
🇵ðŸ‡Manila, Philippines
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
Spitalul Clinic de Urgente pentru Copii "Sf. Maria"
🇷🇴Iasi, Romania
Spitalul de Psihiatrie "Dr. Gh. Preda"
🇷🇴Sibiu, Romania
Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2"
🇺🇦S. Oleksandrivka, Komintern. R-N, Odeska OBL., Ukraine
Ivano-Frankivska oblasna dytiacha klinichna likarnia
🇺🇦Ivano-Frankivsk, Ukraine
Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii,
🇺🇦Uzhgorod, Ukraine
Institute for Child and Youth Healthcare of Vojvodina
🇷🇸Novi Sad, Vojvodina, Serbia
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Dokuz Eylul Ün. Tip Fakültesi İç Hastalıkları
🇹🇷Izmir, Turkey
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasna klinichna psykhiatrychna li
🇺🇦Kharkiv, Ukraine
Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z
🇺🇦Kyiv, Ukraine
University Children's Hospital
🇷🇸Belgrade, Serbia
Marmara University Pendik Training and Research Hospital
🇹🇷Istanbul, UST Kaynarca/pendik, Turkey
Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
🇺🇦Dnipro, Ukraine
Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivska oblasna klinichna likarnia"
🇺🇦Lviv, Ukraine
Eskisehir Osmangazi University Medical Faculty Department Of Neurology
🇹🇷Eskisehir, Turkey
Celal Bayar University School of Medicine, Neurology Department
🇹🇷Manisa, Turkey
Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia No. 5"
🇺🇦Dnipro, Ukraine
Barts Health NHS Foundation Trust, The Royal London Hospital
🇬🇧London, United Kingdom
Salford Royal NHS Foundation Trust
🇬🇧Salford, United Kingdom
St. Alexius Medical Center
🇺🇸Hoffman Estates, Illinois, United States
Ohio Clinical Research Partners, LLC
🇺🇸Canton, Ohio, United States
Scott & White Memorial Hospital and Clinic
🇺🇸Temple, Texas, United States
Pediatric Epilepsy Center of Central Florida
🇺🇸Orlando, Florida, United States
Medsol Clinical Research Center
🇺🇸Port Charlotte, Florida, United States