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A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine

2026年11月11日 更新者：TriGemX Bio, Inc.

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Acute Treatment of Migraine

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

1500

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Arizona
      • Glendale、Arizona、アメリカ、85304
        • まだ募集していません
        • Sun City Clinical Research
        • コンタクト：
      • Phoenix、Arizona、アメリカ、85006
        • 募集
        • Velocity Clinical Research, Phoenix
        • コンタクト：
      • Phoenix、Arizona、アメリカ、85012
        • 募集
        • IMA Clinical Research - Phoenix
        • コンタクト：
    • Arkansas
      • Little Rock、Arkansas、アメリカ、72211
        • 募集
        • Preferred Research Partners, Inc.
        • コンタクト：
    • California
      • Canoga Park、California、アメリカ、91304
        • 募集
        • Alliance Research Institute, Canoga Park
        • コンタクト：
      • Chula Vista、California、アメリカ、91911
        • 募集
        • Velocity Clinical Research, Chula Vista
        • コンタクト：
      • Fountain Valley、California、アメリカ、92708
        • 募集
        • Ark Clinical Research, Fountain Valley
        • コンタクト：
      • Fullerton、California、アメリカ、92835
        • 募集
        • Neurology Center of North Orange County
        • コンタクト：
      • Glendale、California、アメリカ、91206
      • Long Beach、California、アメリカ、90806
        • 募集
        • Long Beach Clinical Trials Services, Inc
        • コンタクト：
      • Long Beach、California、アメリカ、90807
        • 募集
        • Accellacare - Long Beach
        • コンタクト：
      • Lynwood、California、アメリカ、90262
        • 募集
        • Alliance Research Institute, Lynwood
        • コンタクト：
      • Northridge、California、アメリカ、91325
        • まだ募集していません
        • Northridge Clinical Trials
        • コンタクト：
      • Pasadena、California、アメリカ、91101
        • 募集
        • Pasadena Clinical Trials
        • コンタクト：
      • Redding、California、アメリカ、96001
        • 募集
        • Paradigm Clinical Research Centers, LLC
        • コンタクト：
      • San Diego、California、アメリカ、92108
        • 募集
        • Paradigm Clinical Research Centers, LLC
        • コンタクト：
      • San Diego、California、アメリカ、92108
      • San Francisco、California、アメリカ、94102
        • 募集
        • Optimus Medical Group
        • コンタクト：
      • Santa Ana、California、アメリカ、92703
      • Van Nuys、California、アメリカ、91606
        • 募集
        • Velocity Clinical Research, Van Nuys
        • コンタクト：
    • Colorado
      • Aurora、Colorado、アメリカ、80012
        • 募集
        • Paradigm Clinical Research Centers, LLC; Aurora
        • コンタクト：
      • Denver、Colorado、アメリカ、80246
    • Connecticut
      • Stamford、Connecticut、アメリカ、06905-1206
        • 募集
        • Ki Health Partners, LLC
        • コンタクト：
    • Florida
      • Hallandale、Florida、アメリカ、33009
        • 募集
        • Velocity Clinical Research, Hallandale Beach
        • コンタクト：
      • Lakeland、Florida、アメリカ、33805
        • 募集
        • Clinical Research of Central Florida
        • コンタクト：
      • Miami、Florida、アメリカ、33155
      • Ocoee、Florida、アメリカ、34761
      • Orlando、Florida、アメリカ、32819
      • Tampa、Florida、アメリカ、33613
        • 募集
        • Cenexel Tampa FL
        • コンタクト：
      • West Palm Beach、Florida、アメリカ、33407
        • 募集
        • Premiere Research Institute at Palm Beach Neurology
        • コンタクト：
    • Georgia
      • Atlanta、Georgia、アメリカ、30328
        • 募集
        • Clinical Integrative Research Center of Atlanta
        • コンタクト：
      • Norcross、Georgia、アメリカ、30092
      • Savannah、Georgia、アメリカ、31406
        • 募集
        • Velocity Clinical Research, Savannah
        • コンタクト：
    • Idaho
      • Boise、Idaho、アメリカ、83709
        • 募集
        • Paradigm Clinical Research Centers, LLC
        • コンタクト：
    • Illinois
      • Gurnee、Illinois、アメリカ、60031
        • 募集
        • Clinical Investigation Specialists, Inc.
        • コンタクト：
      • Skokie、Illinois、アメリカ、60077
        • 募集
        • Evanston Premier Healthcare Research, LLC
        • コンタクト：
    • Indiana
      • Indianapolis、Indiana、アメリカ、46254
      • Merrillville、Indiana、アメリカ、46410
    • Iowa
      • Ames、Iowa、アメリカ、50010
      • Sioux City、Iowa、アメリカ、51106
        • 募集
        • Velocity Clinical Research, Sioux City
        • コンタクト：
    • Massachusetts
      • Fall River、Massachusetts、アメリカ、02721
        • 募集
        • NECCR PrimaCare Research, LLC
        • コンタクト：
      • Foxborough、Massachusetts、アメリカ、02035
        • 募集
        • Neurology Center of New England P.C.
        • コンタクト：
    • Montana
      • Missoula、Montana、アメリカ、59808
    • Nebraska
      • Norfolk、Nebraska、アメリカ、68701
        • 募集
        • Velocity Clinical Research, Norfolk
        • コンタクト：
      • Omaha、Nebraska、アメリカ、68114
        • 募集
        • Quality Clinical Research, Inc.
        • コンタクト：
    • Nevada
      • Las Vegas、Nevada、アメリカ、89121
        • 募集
        • Oasis Clinical Research
        • コンタクト：
    • New Jersey
      • Toms River、New Jersey、アメリカ、08755
        • 募集
        • Bio Behavioral Health
        • コンタクト：
          • Ashok Patel
          • 電話番号：732-244-2299
          • メール：ap@bbhnj.com
    • North Carolina
      • Cary、North Carolina、アメリカ、27518
        • 募集
        • Accellacare - Cary (Cary Medical Group)
        • コンタクト：
      • Morehead City、North Carolina、アメリカ、28557
      • Raleigh、North Carolina、アメリカ、27609
        • 募集
        • Accellacare - Raleigh (Raleigh Medical Group, P.A.)
        • コンタクト：
      • Wilmington、North Carolina、アメリカ、28401
      • Winston-Salem、North Carolina、アメリカ、27103
    • North Dakota
      • Fargo、North Dakota、アメリカ、58104
    • Ohio
      • Beachwood、Ohio、アメリカ、44122
        • 募集
        • Velocity Clinical Research, Cleveland
        • コンタクト：
      • Blue Ash、Ohio、アメリカ、45242
        • 募集
        • Velocity Clinical Research, Cincinnati, Blue Ash
        • コンタクト：
      • Cincinnati、Ohio、アメリカ、45236
        • 募集
        • Headache Center of Hope
        • コンタクト：
      • Columbus、Ohio、アメリカ、43213
    • Rhode Island
      • Providence、Rhode Island、アメリカ、02818
        • 募集
        • Velocity Clinical Research, Providence
        • コンタクト：
    • South Carolina
      • Anderson、South Carolina、アメリカ、29621
      • Gaffney、South Carolina、アメリカ、29340
        • 募集
        • Velocity Clinical Research, Gaffney
        • コンタクト：
    • Texas
      • Austin、Texas、アメリカ、78705
        • 募集
        • Central Texas Clinical Research
        • コンタクト：
      • Beaumont、Texas、アメリカ、77702
        • 募集
        • Gadolin Research, LLC
        • コンタクト：
      • Dallas、Texas、アメリカ、75230
        • 募集
        • Velocity Clinical Research, Dallas
        • コンタクト：
      • DeSoto、Texas、アメリカ、75115
        • 募集
        • Epic Medical Research - DeSoto
        • コンタクト：
      • El Paso、Texas、アメリカ、79902
        • 募集
        • Newco 3A Researh LLC, DBA 3A Research
        • コンタクト：
      • Lake Jackson、Texas、アメリカ、77566
      • San Antonio、Texas、アメリカ、78240
        • 募集
        • San Antonio Clinical Trials
        • コンタクト：
      • San Antonio、Texas、アメリカ、78229
        • 募集
        • Clinical Trials of Texas, LLC, A Flourish Research Site
        • コンタクト：
      • Sugar Land、Texas、アメリカ、77479
        • 募集
        • DM Clinical Research, Sugar Land
        • コンタクト：
      • Tomball、Texas、アメリカ、77375
        • 募集
        • DM Clinical Research, Tomball
        • コンタクト：
    • Utah
      • Salt Lake City、Utah、アメリカ、84107
        • 募集
        • Wasatch Clinical Research, LLC
        • コンタクト：
      • Salt Lake City、Utah、アメリカ、84124
        • 募集
        • Highland Clinical Research
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

1. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent.

2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated as documented in the patient's medical records from his/her treating physician or with pharmacy records confirming use of a migraine-specific medication (e.g. triptan, gepant, ditan) for > 1 year, and confirmed by the investigator. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:

a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:

  1. A minimum of 12 months of spontaneous amenorrhea or
  2. A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
  3. At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the subject's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity* OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.

Acceptable methods of birth control are:

  1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
  2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
  3. Intrauterine device (IUD);
  4. Intrauterine hormone-releasing system (IUS);
  5. Bilateral tubal occlusion;
  6. Vasectomized partner;
  7. Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;
  8. Male or female condom with or without spermicide;
  9. Cap, diaphragm or sponge with spermicide;
  10. A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods). * Abstinence can be used as the sole method of contraception if it is in line with the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.

5. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.

Exclusion Criteria:

Patients are excluded from the trial if any of the following criteria apply:

  1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Female participants of child-bearing potential must have a negative serum pregnancy test (β-human chorionic gonadotropin) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.

    Migraine history-related

  2. Has difficulty distinguishing his/her migraine attacks from tension-type headaches.

  3. Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.

  4. Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).

  5. Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.

  6. Was >50 years old at age of first migraine onset.

  7. Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.

    Medical history related

  8. Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine [Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study].

  9. Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months.

  10. Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.

  11. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.

  12. Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.

  13. Has a history of human immunodeficiency virus disease.

  14. Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption.

    Laboratory, vital sign, and electrocardiogram related

  15. Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.

  16. Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of <30 mL/min/1.73 m2.

  17. Has a screening result for alanine aminotransferase or aspartate aminotransferase of >2.0 X upper limit of normal (ULN) or total bilirubin >1.5 X ULN at the Screening visit. Note: An isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.

  18. Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) >450 ms for males and >470 ms for females at screening.

  19. Has a mean value for triplicate seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.

    Medication use and substance abuse related

  20. Has known history of or suspected abuse of alcohol or recreational drugs at Screening.

  21. Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol (THC) or cannabidiol (CBD) within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening.

  22. Has a positive drug screen at screening. Note:

    1. If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.
    2. If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.

  23. Is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol).

  24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.

  25. Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.

  26. Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.

    Other

  27. Has known or suspected hypersensitivity to trial product(s) or related products.

  28. Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.

  29. Has any surgery scheduled for the duration of the trial.

  30. Has a screening hemoglobin <11.0 g/dL (males) or <10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).

  31. Has previous participation in this trial. Participation is defined as signed informed consent.

  32. Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P003. Note: Patients may not be screened at more than one trial site for this study.

  33. Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.

  34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site. Note: Rescreening/retesting is not permitted unless specified above.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Elismetrep 10 mg

Participants received a single dose of elismetrep 10 mg
薬：Elismetrep

Administered orally

他の名前：
  • K-304
実験的：Elismetrep 20 mg

Participants received a single dose of elismetrep 20 mg
薬：Elismetrep

Administered orally

他の名前：
  • K-304
プラセボコンパレーター：Placebo

Participants received a single dose of placebo
薬：Placebo

Administered orally

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pain freedom at 2 hours post-dose
時間枠：Two hours post-dose

Percentage of subjects who report no pain at 2 hours post-dose. Pain will be measured on a 4-point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
Two hours post-dose
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
時間枠：Two hours post-dose

Percentage of subjects who report absence of their MBS (nausea, phonophobia, or photophobia) at 2 hours post-dose. MBS will be measured using a binary scale (0=absent, 1=present).
Two hours post-dose

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of participants who experience one or more treatment-emergent adverse events (AEs)
時間枠：Up to 8 days post-dose
Up to 8 days post-dose
Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)
時間枠：Up to 8 days post-dose
Up to 8 days post-dose
Pain relief at 2 hours post-dose
時間枠：Two hours post-dose

Percentage of subjects who report a pain level of moderate of severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then report a pain level of none or mild (responses of 0 or 1 on the 4-point Likert scale) at 2 hours post-dose.
Two hours post-dose
Sustained pain freedom from 2 to 24 hours post-dose
時間枠：From 2 to 24 hours post-dose

Percentage of subjects who do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
From 2 to 24 hours post-dose
Sustained pain freedom from 2 to 48 hours post-dose
時間枠：From 2 to 48 hours post-dose

Percentage of subjects who do not use any rescue medication, do not experience any headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48 hours post-dose.
From 2 to 48 hours post-dose
Sustained pain relief from 2 to 24 hours post-dose
時間枠：From 2 to 24 hours post-dose

Percentage of subjects who do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2 or 24 hours post-dose.
From 2 to 24 hours post-dose
Sustained pain relief from 2 to 48 hours post-dose
時間枠：From 2 to 48 hours post-dose

Percentage of participants that do not use any rescue medications, do not experience any moderate or severe headache pain through the time period of interest, and do not have missing pain data at 2, 24, or 48 hours post-dose.
From 2 to 48 hours post-dose
Freedom from functional disability at 2 hours post-dose
時間枠：Two hours post-dose

Percentage of subjects who self-report as being able to function normally on the functional disability scale in the subset of subjects who reported any level of disability at baseline. The scale has a 4-point numeric rating: normal (0); mildly impaired (1); moderately impaired (2); severely impaired, requires bedrest (3).
Two hours post-dose
Proportion requiring rescue medication within 24 hours post-dose
時間枠：Within 24 hours post-dose

Percentage of subjects that take rescue medication within 24 hours post-dose.
Within 24 hours post-dose
Freedom from photophobia at 2 hours post-dose
時間枠：Two hours post-dose

Percentage of subjects who report the absence of photophobia at 2 hours post-dose in the subset of subjects who reported the presence of photophobia at baseline.
Two hours post-dose
Freedom from phonophobia at 2 hours post-dose
時間枠：Two hours post-dose

Percentage of subjects who report the absence of phonophobia at 2 hours post-dose in the subset of subjects who reported the presence of phonophobia at baseline.
Two hours post-dose
Freedom from nausea at 2 hours post-dose
時間枠：Two hours post-dose

Percentage of subjects who report the absence of nausea at 2 hours post-dose in the subset of subjects who reported the presence of nausea at baseline.
Two hours post-dose
Pain relapse from 2 to 48 hours post-dose
時間枠：From 2 to 48 hours post-dose

Percentage of subjects who are pain free at 2 hours post-dose and have (a) mild, moderate, or severe pain (response of 1, 2, or 3 on the 4-point Likert scale) at any time point after 2 hours post-dose, or (b) missing pain data at 24 hours or 48 hours after 2 hours post-dose, or (c) intervening rescue medication use at or before 48 hours post-dose.
From 2 to 48 hours post-dose

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

TriGemX Bio, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年10月2日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2027年12月1日

試験登録日

最初に提出

2026年9月7日

QC基準を満たした最初の提出物

2026年9月7日

最初の投稿 (実際)

2026年9月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月11日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • K-304 P004

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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