Generalized Tonic Clonic Seizures Clinical Trial
Official title:
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
| Verified date | August 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 219 |
| Est. completion date | February 20, 2019 |
| Est. primary completion date | February 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 65 Years |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medizinische Universitaet Innsbruck | Innsbruck | |
| Austria | AKH Linz | Linz | |
| Belarus | UZ Vitebsk Regional Childrens Clinical Centre | Vitebsk | |
| Belarus | UZ Vitebsk Regional Childrens Clinical Centre | Vitebsk | |
| 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 | University Clinical Center Sarajevo | Sarajevo | Canton Sarajevo |
| Bosnia and Herzegovina | University Clinical Center Tuzla | Tuzla | Canton Tuzla |
| Bulgaria | 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 | Ruse | |
| Bulgaria | DCC Sveta Anna - Sofia | Sofia | |
| Bulgaria | MHATNP Sveti Naum EAD | Sofia | |
| Bulgaria | UMHAT Aleksandrovska | Sofia | |
| China | The First Bethune Hospital of Jilin University | Changchun | Jilin |
| China | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
| China | Shanghai Huashan Hospital, Neurology Department | Shanghai | Shanghai |
| Croatia | University Hospital Center Split, Clinic for Neurology | Split | |
| Denmark | Aarhus University Hospital | Aarhus C | |
| Denmark | Odense University Hospital | Odense C | |
| France | CHU d'Amiens - Picardie | Amiens Cedex 1 | |
| France | CHRU de Rennes - Hôpital Pontchaillou | Rennes | |
| France | CHU d'Amiens Hopital Pontchaillou | Rennes | |
| Greece | Athens Medical Center | Athens | |
| Greece | Eginition Hospital | Athens | |
| Greece | General Children's Hospital Penteli | Athens | |
| Greece | University General Hospital of Thessaloniki "AHEPA" | Thessaloniki | |
| Hungary | Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika | Budapest | |
| Hungary | Csongrad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely-Mako | Hodmezovasarhely | |
| Hungary | Pest Megyei Flór Ferenc Kórhaz | Kistarcsa | |
| India | 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 | Indraprastha Apollo Hospitals | New Delhi | Delhi |
| India | KEM Hospital Research Centre | Pune | Maharashtra |
| India | Sahyadri Speciality Hospital | Pune | Maharashtra |
| Korea, Republic of | Keimyung University Dongsan Hospital | Daegu | Korea |
| Korea, Republic of | Konkuk University medical center | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Lebanon | Saint George Hospital - University Medical Center | Beirut | |
| Lebanon | Ain Wazein Medical Village | El Chouf | |
| Malaysia | Hospital Raja Permaisuri Bainun | Ipoh | Perak |
| Montenegro | Pzu Neuron | Bijelo Polje | |
| Philippines | Cebu Doctors' University Hospital | Cebu City | Cebu |
| Philippines | Cebu Doctors' University Hospital, Rm Ph 7 | Cebu City | |
| Philippines | Perpetual Succour Hospital | Cebu City | Cebu |
| 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 | |
| Poland | COPERNICUS Podmiot Leczniczy Spzoo | Gdansk | |
| Poland | Neuro-Care Gabriela Klodowska | Katowice | |
| Poland | NZOZ Novo Med | Katowice | |
| Poland | NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS | 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 | Swidnik | |
| Poland | Lecznica Medyczna ''Zycie" | Warsaw | |
| Romania | Centrul Medical de Diagnostic si Tratament Ambulator Neomed | Brasov | |
| Romania | CMI Neurologie, Neurofiziologie (EEG, EMG, PEC) Roceanu Adina Maria | Bucuresti | |
| Romania | Sapiens Medical Center | Bucuresti | |
| Romania | Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" | Iasi | |
| Romania | Spitalul Clinic de Urgente pentru Copii "Sf. Maria" | Iasi | |
| Romania | Spitalul de Psihiatrie "Dr. Gh. Preda" | Sibiu | |
| 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 | GBOU VPO "Kazan State Medical University" of Roszdrav | Kazan | Republic OF Tatarstan |
| Russian Federation | Republican clinical hospital | Kazan | Republic OF Tatarstan |
| Russian Federation | Non-state Healthcare Institution | Moscow | |
| Russian Federation | Nizhmedklinika | Nizhniy Novgorod | Nizhegorodskaya Oblast |
| Russian Federation | LLC City Neurological Center "Sibneiromed" | Novosibirsk | |
| Russian Federation | Perm State Medical University n. a. acad. E.A. Vagner | Perm | |
| Russian Federation | Perm State Medical University n. a. acad. E.A. Vagner | Perm | Permskiy KRAY |
| Russian Federation | SPHI Leningrad Regional Psychoneurological Dispensary | Pgt. Roshchino | Leningrad Region |
| Russian Federation | State Budgetary Healthcare Institution of Stavropol region | Pyatigorsk | Stavropol Region |
| Russian Federation | FSBI V.M. Bekhterev National Research Medical Center for | Saint Petersburg | |
| Russian Federation | SBHI of Saint Petersburg Psychoneurological Dispensary #5 | Saint Petersburg | |
| Russian Federation | SBHI of Saint Petersburg Psychoneurological Dispensary #5 | Saint Petersburg | |
| Russian Federation | SPHI Leningrad Regional Psychoneurological Dispensary | Saint-Petersburg | |
| Russian Federation | GBOU VPO Smolensk State Medical University | Smolensk | |
| Russian Federation | Regional State Budgetary Institution of Ministry of Health | Smolensk | |
| Russian Federation | RSBHI Smolensk Regional Clinical Hospital | Smolensk | |
| Russian Federation | SHI "Central Clinical Medical Unit | Ulyanovsk | |
| Russian Federation | SHI "Central Clinical Medical Unit | Ulyanovsk | |
| Serbia | Institute for Mental Health | Belgrade | |
| Serbia | University Children's Hospital | Belgrade | |
| Serbia | Clinical Center Kragujevac | Kragujevac | |
| Serbia | Institute for Child and Youth Healthcare of Vojvodina | Novi Sad | Vojvodina |
| Slovakia | Nemocnica s poliklinikou Hlohovec, s.r.o. | Hlohovec | |
| Slovakia | Neurologicka ambulancia MUDr. Eva Gasparova | Hlohovec | |
| Spain | Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona |
| Turkey | Eskisehir Osmangazi University Medical Faculty Department Of Neurology | Eskisehir | |
| Turkey | Marmara University Pendik Training and Research Hospital | Istanbul | UST Kaynarca/pendik |
| Turkey | Dokuz Eylul Ün. Tip Fakültesi Iç Hastaliklari | Izmir | |
| Turkey | Celal Bayar University School of Medicine, Neurology Department | Manisa | |
| 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 | Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2" | S. Oleksandrivka | Komintern. R-N, Odeska OBL. |
| Ukraine | Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, | Uzhgorod | |
| Ukraine | Komunalna ustanova "Miska klinichna likarnia #2", nevrolohichne viddilennia | Zaporizhzhia | |
| United Kingdom | 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 States | Ohio Clinical Research Partners, LLC | Canton | Ohio |
| 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 | Hawaii Pacific Neuroscience | Honolulu | Hawaii |
| United States | 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 | Rainier Clinical Research Center, Inc. | Renton | Washington |
| United States | Road Runner Research, Ltd | San Antonio | Texas |
| United States | Scott & White Memorial Hospital and Clinic | Temple | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States, Austria, Belarus, Bosnia and Herzegovina, Bulgaria, China, Croatia, Denmark, France, Greece, Hungary, India, Korea, Republic of, Lebanon, Malaysia, Montenegro, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | 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. | Day 1 up to Week 12 |