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Undersøk effektiviteten og sikkerheten til karisbamat som tilleggsbehandling for anfall assosiert med LGS hos barn og voksne

3. november 2026 oppdatert av: SK Life Science, Inc.

En randomisert, dobbeltblind, placebokontrollert studie for å undersøke effektiviteten og sikkerheten til karisbamat (YKP509) som tilleggsbehandling for anfall assosiert med Lennox-Gastaut syndrom hos barn og voksne, med valgfri åpen etikettforlengelse

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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

252

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 år til 55 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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]).
Eksperimentell: 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
Legemiddel: 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]).
Placebo komparator: 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
Legemiddel: 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]).
Placebo komparator: 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
Legemiddel: 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]).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 3 years

Efficacy of Carisbamate YKP509
3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 3 years

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 3 years

Efficacy of Carisbamate YKP509
3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

SK Life Science, Inc.

Etterforskere

  • Studieleder: Marc Kamin, MD, SK Life Science, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. april 2022

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

6. januar 2022

Først innsendt som oppfylte QC-kriteriene

20. januar 2022

Først lagt ut (Faktiske)

2. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YKP509C003

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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