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Investigar a eficácia e segurança do carisbamato como tratamento adjuvante para convulsões associadas à LGS em crianças e adultos

3 de novembro de 2026 atualizado por: SK Life Science, Inc.

Um estudo randomizado, duplo-cego, controlado por placebo para investigar a eficácia e a segurança do carisbamato (YKP509) como tratamento adjuvante para convulsões associadas à síndrome de Lennox-Gastaut em crianças e adultos, com extensão aberta opcional

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

The secondary objectives are:

  • To evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the total number of seizures compared with placebo in pediatric and adult subjects diagnosed with Lennox Gastaut Syndrome (LGS)
  • Evaluate the safety, tolerability of carisbamate in the LGS population
  • Evaluate steady-state pharmacokinetics of carisbamate in subjects with Lennox Gastaut.

Tipo de estudo

Intervencional

Inscrição (Estimado)

252

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Barbara Remes
  • Número de telefone: 201-421-3810
  • E-mail: bremes@sklsi.com

Locais de estudo

  • Alemanha
    • Bavaria
      • Erlangen, Bavaria, Alemanha
        • Recrutamento
        • Universitatsklinikum Erangen
        • Investigador principal:
          • Hajo Martinus Hamer, MD
    • Saxony
      • Radeberg, Saxony, Alemanha
        • Recrutamento
        • Kleinwachau Sächsisches Epilepsiezentrum
        • Investigador principal:
          • Nils Holert, MD
  • Argentina
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina
        • Concluído
        • Hospital de Ninos de La Santisma Trinidad
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentina
        • Concluído
        • Resolution Psychopharmacology Research Institute
  • Austrália
      • Heidelberg, Austrália
        • Recrutamento
        • Austin Hosptial
        • Investigador principal:
          • Ingrid Scheffer, MD
      • Melbourne, Austrália
        • Recrutamento
        • Alfred Health
        • Investigador principal:
          • Patrick Kwan
      • Nedlands, Austrália
        • Concluído
        • Perth's Children Hospital
      • South Brisbane, Austrália
        • Concluído
        • Queensland Children's Hospital
  • Colômbia
      • Barranquilla, Colômbia
        • Retirado
        • Fundacion Hospital Universidad del Norte
      • Cali, Colômbia
        • Retirado
        • Fundacion Valle del Lili/Clinic - Outpatient
      • Envigado, Colômbia
        • Concluído
        • CliniSalud del Sur S.A.S - Centro de Investigación
      • Medellín, Colômbia
        • Concluído
        • Hospital Pabloe Tubon Uribe
      • Medellín, Colômbia
        • Concluído
        • Institutio Neurologico de Colombia
  • Coréia do Sul
      • Daegu, Coréia do Sul
        • Concluído
        • Kyungpook National University Chilgok Hospital
      • Seoul, Coréia do Sul
        • Recrutamento
        • Samsung Medical Center
        • Investigador principal:
          • Jee Hun S. Lee, MD
      • Seoul, Coréia do Sul
        • Recrutamento
        • Seoul National University Hospital
        • Investigador principal:
          • Byung Chan Lim, MD
  • Espanha
      • Madrid, Espanha
        • Recrutamento
        • Hospital Ruber Internacional (Grupo Quironsalud)
        • Investigador principal:
          • Antonio Gil-Nigel, MD
      • Madrid, Espanha
        • Concluído
        • Hospital Infantil Universitario Niño Jesus - PIN
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Espanha
        • Concluído
        • Hospital Sant Joan de Deu - PIN
  • Estados Unidos
    • California
      • Palo Alto, California, Estados Unidos, 94305
        • Recrutamento
        • Stanford University Hospital
        • Investigador principal:
          • Brenda Porter, MD
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32209
        • Concluído
        • University of Florida Health Science Center
      • Orlando, Florida, Estados Unidos, 32803
        • Concluído
        • AdventHealth
      • Tampa, Florida, Estados Unidos, 33609
        • Recrutamento
        • Pediatric Epilepsy and Neurology Specialists
        • Investigador principal:
          • Jose Ferreira, MD
      • Tampa, Florida, Estados Unidos, 33620
        • Concluído
        • University of South Florida
      • Wellington, Florida, Estados Unidos, 33414
        • Concluído
        • Axcess Medical Research
    • Idaho
      • Boise, Idaho, Estados Unidos, 83702
        • Concluído
        • Consultants in Epilepsy and Neurology PLLC
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40504
        • Concluído
        • Bluegrass Epilepsy Research, LLC
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Concluído
        • University Medical Center New Orleans
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Recrutamento
        • Johns Hopkins Hospital
        • Investigador principal:
          • Joon Yi Kang, MD
      • Bethesda, Maryland, Estados Unidos, 20817
        • Recrutamento
        • Mid-Atlantic Epilepsy and Sleep Center
        • Contato:
          • Arkady Barber
        • Investigador principal:
          • Pavel Klein, MD
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Concluído
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65211
        • Concluído
        • University of Missouri School of Medicine
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Recrutamento
        • Northeast Regional Epilepsy Group
        • Investigador principal:
          • Eric Segal, MD
      • New Brunswick, New Jersey, Estados Unidos, 08901
        • Concluído
        • St. Peters Hospital
    • New York
      • The Bronx, New York, Estados Unidos, 10467
        • Concluído
        • Montefiore
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27713
        • Recrutamento
        • Duke University Clinical Research at Pickett Road
        • Investigador principal:
          • Muhammad Zafar, MD
      • Winston-Salem, North Carolina, Estados Unidos, 27101
        • Concluído
        • Wake Forest University - School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Recrutamento
        • Children's Hospital of Philadelphia
        • Investigador principal:
          • Eric Marsh, MD
    • Texas
      • Austin, Texas, Estados Unidos, 78758
        • Concluído
        • Austin Epilepsy Care Center - Clinic/Outpatient Facility
      • Dallas, Texas, Estados Unidos, 75231
        • Concluído
        • Neurology Consultants of Dallas, PA - Hospital
    • Virginia
      • Winchester, Virginia, Estados Unidos, 22601
        • Concluído
        • Virginia Epilepsy and Neurodevelopmental Clinic at WNC
  • Grécia
    • Attica
      • Marousi, Attica, Grécia
        • Concluído
        • Iaso Children's Hospital
  • Hungria
      • Budapest, Hungria
        • Concluído
        • Orszagos Mentalis, Ideggyogyaszati es Idegsebezeti Intezet
      • Budapest, Hungria
        • Recrutamento
        • Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
        • Contato:
          • Anna Sakovics, MD
  • Israel
      • Beersheba, Israel
        • Concluído
        • Soroka University Medical Centre
      • Jerusalem, Israel, 91220
        • Concluído
        • Hadassah Medical Center
      • Ramat Gan, Israel
        • Concluído
        • Sheba Medical Center
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel
        • Concluído
        • Tela Viv Sourlasky Medical Center
  • Itália
      • Florence, Itália
        • Concluído
        • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
      • Milan, Itália
        • Concluído
        • ASST Santi Paolo E Carlo - Azienda Universitaria-Polo Universitaria - San Paolo
    • Liguria
      • Genoa, Liguria, Itália
        • Recrutamento
        • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
        • Investigador principal:
          • Pasquale Striano, MD
    • Lombardy
      • Milan, Lombardy, Itália
        • Recrutamento
        • ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi
        • Investigador principal:
          • Monica Lodi, MD
      • Milan, Lombardy, Itália
        • Recrutamento
        • Fondazione IRCCS Di Rilievo Nazionale Instituto
        • Investigador principal:
          • Elena Freri, MD
    • Verona
      • Verona, Verona, Itália
        • Recrutamento
        • Azienda Ospedaliera Universitaria Integrata Di Verona
        • Investigador principal:
          • Francesca Darra, MD
  • México
      • Culiacán, México
        • Recrutamento
        • Neurociencias Estudios Clinicos S.C.
        • Investigador principal:
          • Elmer Lopez Meza, MD
      • Mexico City, México, 06700
        • Recrutamento
        • Clinstile, S.A. de C.V.
        • Investigador principal:
          • Sandra Quinones, MD
    • Jalisco
      • Guadalajara, Jalisco, México
        • Recrutamento
        • Hospital Civil Fray Antonio Alcalde
        • Investigador principal:
          • Hugo Ceja Moreno, MD
  • Polônia
      • Krakow, Polônia
        • Recrutamento
        • Centrum Medyczne Plejady
        • Investigador principal:
          • Marta Zolnowska, MD
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polônia
        • Concluído
        • Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2
  • Portugal
    • Lisbon District
      • Lisbon, Lisbon District, Portugal
        • Recrutamento
        • Centro Hospitalar de Lisboa Norte, EPE
        • Investigador principal:
          • Sofia Quintas, MD
      • Lisbon, Lisbon District, Portugal
        • Concluído
        • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
    • Porto District
      • Porto, Porto District, Portugal
        • Recrutamento
        • Centro Hospitalar de Sao Joao, EPE
        • Investigador principal:
          • Raquel Sousa, MD
    • Setúbal District
      • Almada, Setúbal District, Portugal
        • Concluído
        • Hospital Garcia de Orta
  • Sérvia
      • Belgrade, Sérvia
        • Recrutamento
        • University Clinical Center of Serbia - PPDS
        • Investigador principal:
          • Dragoslav Sokic, MD
      • Kragujevac, Sérvia
        • Recrutamento
        • University Clinical Center Kragujevac
        • Investigador principal:
          • Aleksandar Gavrilovic, MD
      • Niš, Sérvia
        • Recrutamento
        • University Clinical Center Nis
        • Investigador principal:
          • Tatjana Tosic, MD
      • Novi Sad, Sérvia
        • Recrutamento
        • Children and Youth Health Care Institute of Vojvodina
        • Investigador principal:
          • Marija Knezevic-Pogancev, MD
        • Contato:
          • Tatjana Redzek Mudrinic, MD
    • Belgrade
      • Belgrade, Belgrade, Sérvia
        • Recrutamento
        • Childrens University Hospital
        • Investigador principal:
          • Dimitrije Nikolic, MD
  • Taiwan
      • Taipei, Taiwan
        • Recrutamento
        • Taipei Veterans General Hospital
        • Investigador principal:
          • Ting-Rong Hsu, MD
      • Taipei, Taiwan
        • Recrutamento
        • National Taiwan University Hospital
        • Investigador principal:
          • Wang-Tso Lee, MD
      • Taoyuan, Taiwan
        • Concluído
        • Chang Gung Memorial Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

4 anos a 55 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Subject must have a documented history of Lennox-Gastaut syndrome by:

    1. Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure
    2. History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern <3.0 Hz)
    3. History of developmental delay

  2. Male or female subjects

  3. Subjects must be age 4-55 years at the time of consent/assent

  4. Must have been <11 years old at the onset of LGS

  5. Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) during the 4-week Baseline period preceding randomization (minimum of 4 drop seizures in the first two weeks and 4 in the last two weeks). Drop seizures are defined as a seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. All drop seizure types must be countable (either as isolated seizures or as countable isolated seizures in a cluster).

  6. Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1

  7. If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.

  8. Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.

  9. Parents or caregivers must be able to keep accurate seizure diaries

  10. Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study, if able.

  11. Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study

  12. Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements

  13. History of COVID-19 vaccination is permitted

Exclusion Criteria:

  1. Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor
  2. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct
  3. Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline
  4. Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling
  5. Current use of felbamate with less than 18 months of continuous exposure
  6. Concomitant use of vigabatrin: subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test, if able.
  7. Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline
  8. Status epilepticus within 12 weeks prior to Visit 1
  9. Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as evaluated by the Investigator
  10. Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2)
  11. Subject has a history of any serious drug-induced hypersensitivity, e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]) or any drug-related rash requiring hospitalization
  12. Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated <5 months year prior to enrollment. Stimulation parameters that have been stable for <4 weeks, or Battery life of unit not anticipated to extend for duration of trial.
  13. Subject is pregnant, may be pregnant, lactating or planning to be pregnant
  14. Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering "Yes" to questions 4 or 5 in the Suicidal Ideation section of the age- specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated
  15. Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.
  16. Evidence of significant active hepatic disease. Stable elevations of liver enzymes (alanine aminotransferase (ALT), and aspartate aminotransferase (AST)) due to concomitant medication(s) will be allowed if they are <3 x ULN
  17. Subject with total bilirubin [TBL] >2 x ULN (except for Gilbert's syndrome).
  18. Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1)
  19. History of positive antibody/antigen test for human immunodeficiency virus (HIV)
  20. If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products
  21. Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study
  22. Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1)
  23. Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A) including, but not limited to: phenobarbital, phenytoin, carbamazepine, primidone, rifampin, troglitazone, St. John's Wort, efavirenz, nevirapine, glucocorticoids (other than topical usage), modafinil, pioglitazone, and rifabutin
  24. Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome
  25. Subject with a short QTc interval (<340 msec) or long QTc interval (>460 msec) as confirmed by a repeated electrocardiogram (ECG)
  26. Benzodiazepine rescue administered on average more than once a week in the month before Visit 1
  27. Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Carisbamate 200 mg BID arm

Age: 4 to <12y* Titration: 2 mg/kg BID Maintenance: 4 mg/kg BID

Age: ≥12 y Titration: 100 mg BID Maintenance: 200 mg BID
Medicamento: Carisbamate

Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to < 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID [or a total of 400 mg per day]).

Subjects 4 to < 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID [or a total of 600 mg per day]).
Experimental: Carisbamate 300 mg BID arm

Age: 4 to <12y* Titration: 2.75 mg/kg BID Maintenance: 5.5 mg/kg BID

Age: ≥12 y Titration: 150 mg BID Maintenance: 300 mg BID
Medicamento: Carisbamate

Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to < 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID [or a total of 400 mg per day]).

Subjects 4 to < 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID [or a total of 600 mg per day]).
Comparador de Placebo: Placebo matched to 200 mg BID arm

Age: 4 to <12y* Titration: Volume equivalent to 2 mg/kg BID Maintenance: Volume equivalent to 4 mg/kg BID

Age: ≥12 y Titration: Volume equivalent to 100 mg BID Maintenance: Volume equivalent to 200 mg BID
Medicamento: Carisbamate

Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to < 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID [or a total of 400 mg per day]).

Subjects 4 to < 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID [or a total of 600 mg per day]).
Comparador de Placebo: Placebo matched to 300 mg BID arm

Age: 4 to <12y* Titration: Volume equivalent to 2.75 mg/kg BID Maintenance: Volume equivalent to 5.5 mg/kg BID

Age: ≥12 y Titration: Volume equivalent to 150 mg BID Maintenance: Volume equivalent to 300 mg BID
Medicamento: Carisbamate

Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to < 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID [or a total of 400 mg per day]).

Subjects 4 to < 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID [or a total of 600 mg per day]).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.
Prazo: 3 years

Efficacy of Carisbamate YKP509
3 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period.
Prazo: 3 years

Efficacy of Carisbamate YKP509
3 years
Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period.
Prazo: 3 years

Efficacy of Carisbamate YKP509
3 years
Subject/Caregiver Global Impression of Change (S/CGIC) in overall condition score at the last visit.
Prazo: 3 years

Efficacy of Carisbamate YKP509- Scoring will be from 1 to 7 with 1 (very much improved) to 7 (very much worse)
3 years

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Percentage change from baseline in the 28-day frequency of: drop seizures (tonic, atonic, tonic-clonic); non-drop seizures (myoclonic seizures, atypical absence); total seizures during the maintenance phase of the double-blind treatment period.
Prazo: 3 years

Efficacy of Carisbamate YKP509
3 years
Percentage change from baseline in non-drop seizures (myoclonic seizures, atypical absence) frequency per 28 days during the during the double-blind treatment period.
Prazo: 3 years

Efficacy of Carisbamate YKP509
3 years
The percentage of subjects with at least a 50% reduction from baseline in the total frequency of drop seizures (tonic, atonic, tonic-clonic) during the maintenance phase of the double-blind treatment period.
Prazo: 3 years

Efficacy of Carisbamate YKP509
3 years
Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the double-blind treatment period.
Prazo: 3 years

Efficacy of Carisbamate YKP509
3 years
Proportion of subjects with a 75%, 90% and 100% response rate for drop seizures (tonic, atonic, tonic-clonic), non-drop seizures, and total seizures during the maintenance phase of the double-blind treatment period.
Prazo: 3 years

Efficacy of Carisbamate YKP509
3 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

SK Life Science, Inc.

Investigadores

  • Diretor de estudo: Marc Kamin, MD, SK Life Science, Inc.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de abril de 2022

Conclusão Primária (Estimado)

1 de fevereiro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

6 de janeiro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de janeiro de 2022

Primeira postagem (Real)

2 de fevereiro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • YKP509C003

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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