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Étudier l'efficacité et l'innocuité du carisbamate en tant que traitement d'appoint des convulsions associées au LGS chez les enfants et les adultes

3 novembre 2026 mis à jour par: SK Life Science, Inc.

Une étude randomisée, en double aveugle et contrôlée par placebo pour étudier l'efficacité et l'innocuité du carisbamate (YKP509) en tant que traitement d'appoint des convulsions associées au syndrome de Lennox-Gastaut chez les enfants et les adultes, avec extension ouverte facultative

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).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

252

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Barbara Remes
  • Numéro de téléphone: 201-421-3810
  • E-mail: bremes@sklsi.com

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

4 ans à 55 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Médicament: 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]).
Expérimental: 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
Médicament: 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]).
Comparateur 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
Médicament: 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]).
Comparateur 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
Médicament: 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]).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 3 years

Efficacy of Carisbamate YKP509
3 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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.
Délai: 3 years

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 3 years

Efficacy of Carisbamate YKP509
3 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

SK Life Science, Inc.

Les enquêteurs

  • Directeur d'études: Marc Kamin, MD, SK Life Science, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 avril 2022

Achèvement primaire (Estimé)

1 février 2027

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

6 janvier 2022

Première soumission répondant aux critères de contrôle qualité

20 janvier 2022

Première publication (Réel)

2 février 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • YKP509C003

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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