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소아 및 성인의 LGS 관련 발작에 대한 보조 치료로서 Carisbamate의 효능 및 안전성 조사

2026년 11월 3일 업데이트: SK Life Science, Inc.

선택적 공개 확장과 함께 어린이 및 성인의 레녹스-가스토 증후군과 관련된 발작에 대한 보조 치료로서 Carisbamate(YKP509)의 효능 및 안전성을 조사하기 위한 무작위, 이중 맹검, 위약 대조 연구

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).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

252

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

4년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
의약품: 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]).
실험적: 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
의약품: 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]).
위약 비교기: 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
의약품: 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]).
위약 비교기: 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
의약품: 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]).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 3 years

Efficacy of Carisbamate YKP509
3 years

2차 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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.
기간: 3 years

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

기타 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 3 years

Efficacy of Carisbamate YKP509
3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

SK Life Science, Inc.

수사관

  • 연구 책임자: Marc Kamin, MD, SK Life Science, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 4월 28일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2022년 1월 6일

QC 기준을 충족하는 최초 제출

2022년 1월 20일

처음 게시됨 (실제)

2022년 2월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • YKP509C003

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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