此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

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

2026年8月19日更新者：Kallyope 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 efficacy, safety, and tolerability of elismetrep, as compared with placebo, in the acute treatment of migraine.

研究概览

地位

招聘中

条件

偏头痛

干预/治疗

研究类型

介入性

注册 (估计的)

1800

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Annemarie Vance
电话号码：917-336-3654
邮箱：annemarie@kallyope.com

学习地点

美国
- Alabama
  - Birmingham、Alabama、美国、35205
    - 招聘中
    - Central Research Associates, LLC (CRA) dba Flourish Research
    - 接触：
      
      电话号码：(205) 327-1077
  - Mobile、Alabama、美国、36608
    - 招聘中
    - AMR Mobile
    - 接触：
      
      电话号码：(251) 901-2127
- Arizona
  - Chandler、Arizona、美国、85286
    - 招聘中
    - TrialSphere
    - 接触：
      
      电话号码：(623) 267-8314
- Arkansas
  - Little Rock、Arkansas、美国、72205
    - 招聘中
    - Arkansas Clinical Research
    - 接触：
      
      电话号码：(501) 480-5088
- California
  - Colton、California、美国、92324
    - 招聘中
    - Axiom Research, LLC
    - 接触：
      
      电话号码：(909) 824-2325
  - Culver City、California、美国、90230
    - 招聘中
    - Proscience Research Group
    - 接触：
      
      电话号码：(424) 227-8127
  - Encino、California、美国、91316
    - 招聘中
    - Leading Edge Research LA, LLC
    - 接触：
      
      电话号码：(818) 578-4555
  - Irvine、California、美国、92604
    - 招聘中
    - Axiom Research, Orange County
    - 接触：
      
      电话号码：(909) 824-2325
  - Los Angeles、California、美国、90048
    - 招聘中
    - Clinical Research Institute
    - 接触：
      
      电话号码：(323) 879-9999
  - Los Angeles、California、美国、90017
    - 招聘中
    - Downtown L.A. Research Center, Inc.
    - 接触：
      
      电话号码：(213) 261-3680
  - Mission Viejo、California、美国、92691
    - 招聘中
    - M3 Wake Research - Mission Mental Health (WR-MMH)
    - 接触：
      
      电话号码：(949) 752-7910
  - Oceanside、California、美国、92056
    - 招聘中
    - Excell Research
    - 接触：
      
      电话号码：(760) 758-2222
  - Pomona、California、美国、91767
    - 招聘中
    - The Neurology Group
    - 接触：
      
      电话号码：603 (909) 982-2719
  - Pomona、California、美国、91767
    - 招聘中
    - Empire Clinical Research
    - 接触：
      
      电话号码：(909) 981-5321
  - Riverside、California、美国、92503
    - 招聘中
    - Artemis Institute for Clinical Research
    - 接触：
      
      电话号码：(855) 367-8834
  - San Diego、California、美国、92120
    - 招聘中
    - Acclaim Clinical Research
    - 接触：
      
      电话号码：(855) 367-8834
  - Sherman Oaks、California、美国、91403
    - 招聘中
    - CenExel Sherman Oaks CA (California Neuroscience Research)
    - 接触：
      
      电话号码：(818) 990-2671
  - Spring Valley、California、美国、91978
    - 招聘中
    - Encompass Clinical Research
    - 接触：
      
      电话号码：(619) 660-9068
  - Walnut Creek、California、美国、94598
    - 招聘中
    - Diablo Clinical Research
    - 接触：
      
      电话号码：(925) 930-7267
  - Walnut Creek、California、美国、94596
    - 招聘中
    - Sunwise Clinical Research
    - 接触：
      
      电话号码：(925) 298-5147
  - West Covina、California、美国、91790
    - 招聘中
    - Kinetic Clinical Research
    - 接触：
      
      电话号码：(657) 230-7120
  - West Hills、California、美国、91307
    - 招聘中
    - Focus Clinical Research
    - 接触：
      
      电话号码：(818) 253-8966
- Colorado
  - Centennial、Colorado、美国、80112
    - 招聘中
    - IMMUNOe Research Centers
    - 接触：
      
      电话号码：(303) 771-9000
  - Colorado Springs、Colorado、美国、80910
    - 招聘中
    - MCB Clinical Research Centers
    - 接触：
      
      电话号码：(719) 634-6576
  - Fort Collins、Colorado、美国、80528
    - 招聘中
    - Advanced Neurosciences Research
    - 接触：
      
      电话号码：(970) 226-6111
- Connecticut
  - Waterbury、Connecticut、美国、06708
    - 招聘中
    - Chase Medical Research, LLC
    - 接触：
      
      电话号码：(203) 419-4404
- Georgia
  - Atlanta、Georgia、美国、30329
    - 招聘中
    - DelRicht Research
    - 接触：
      
      电话号码：(770) 417-4454
  - Marietta、Georgia、美国、30060
    - 招聘中
    - Drug Studies America
    - 接触：
      
      电话号码：(678) 581-5252
  - Stockbridge、Georgia、美国、30281
    - 招聘中
    - Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
    - 接触：
      
      电话号码：(770) 626-0177
- Illinois
  - Chicago、Illinois、美国、60607
    - 招聘中
    - Cedar Crosse Research Center
    - 接触：
      
      电话号码：(312) 431-6780
  - Chicago、Illinois、美国、60657
    - 招聘中
    - Chicago Headache Center & Research Institute
    - 接触：
      
      电话号码：(773) 935-1000
  - Flossmoor、Illinois、美国、60477
    - 招聘中
    - Healthcare Research Network II, LLC
    - 接触：
      
      电话号码：(708) 388-2245
  - Naperville、Illinois、美国、60563
    - 招聘中
    - Chicago Headache Center & Research Institute
    - 接触：
      
      电话号码：(415) 397-0700
- Iowa
  - West Des Moines、Iowa、美国、50265
    - 招聘中
    - Integrated Clinical Trials Solution
    - 接触：
      
      电话号码：(515) 223-2300
- Kansas
  - Overland Park、Kansas、美国、66214
    - 招聘中
    - Clinical Associates Midwest, LLC
    - 接触：
      
      电话号码：(913) 359-5699
  - Overland Park、Kansas、美国、66212
    - 招聘中
    - Collective Medical Research
    - 接触：
      
      电话号码：(913) 381-7180
  - Wichita、Kansas、美国、67207
    - 招聘中
    - Heartland Research Associates, LLC - An AMR Company
    - 接触：
      
      电话号码：(316) 689-6635
- Kentucky
  - Bardstown、Kentucky、美国、40004
    - 招聘中
    - Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
    - 接触：
      
      电话号码：(502) 349-1569
  - Lexington、Kentucky、美国、40509
    - 招聘中
    - AMR Clinical - Lexington
    - 接触：
      
      电话号码：(859) 264-8999
  - Lexington、Kentucky、美国、45212
    - 招聘中
    - CTI Clinical Research Center
    - 接触：
      
      电话号码：(513) 721-3868
- Louisiana
  - Chalmette、Louisiana、美国、70043
    - 招聘中
    - Crescent City Headache & Neurology Center
    - 接触：
      
      电话号码：(504) 418-6040
  - New Orleans、Louisiana、美国、70115
    - 招聘中
    - DelRicht Research
    - 接触：
      
      电话号码：(504) 336-2667
- Maryland
  - Pikesville、Maryland、美国、21208
    - 招聘中
    - Headlands Research - Pharmasite
    - 接触：
      
      电话号码：(410) 602-1440
- Massachusetts
  - Boston、Massachusetts、美国、02131
    - 招聘中
    - Boston Clinical Trials - Alcanza
    - 接触：
      
      电话号码：(843) 856-3784
  - Waltham、Massachusetts、美国、02451
    - 招聘中
    - MedVadis Research Corporation, LLC
    - 接触：
      
      电话号码：(781) 373-2940
- Michigan
  - Ann Arbor、Michigan、美国、48104
    - 招聘中
    - Michigan Headache Pain & Neurological Institute
    - 接触：
      
      电话号码：Option 4 (734) 677-6000
- Minnesota
  - Minneapolis、Minnesota、美国、55402
    - 招聘中
    - Clinical Research Institute
    - 接触：
      
      电话号码：5 (612) 333-2200
- Mississippi
  - Gulfport、Mississippi、美国、39503
    - 招聘中
    - DelRicht Research
    - 接触：
      
      电话号码：(228) 588-8268
  - Ridgeland、Mississippi、美国、39157
    - 招聘中
    - Proven Endpoints
    - 接触：
      
      电话号码：(601) 790-1811
- Missouri
  - City of Saint Peters、Missouri、美国、63303
    - 招聘中
    - StudyMetrix Research
    - 接触：
      
      电话号码：(636) 387-5100
  - Hazelwood、Missouri、美国、63042
    - 招聘中
    - Healthcare Research Network
    - 接触：
      
      电话号码：(314) 972-9600
  - Kansas City、Missouri、美国、64114
    - 招聘中
    - AMR Clinical - Kansas City
    - 接触：
      
      电话号码：(816) 643-4153
  - Springfield、Missouri、美国、65807
    - 招聘中
    - Clinvest Headlands Llc
    - 接触：
      
      电话号码：(417) 883-7889
  - St Louis、Missouri、美国、63141
    - 招聘中
    - Sundance Clinical Research
    - 接触：
      
      电话号码：(314) 567-3377
- Nevada
  - Las Vegas、Nevada、美国、89109
    - 招聘中
    - Excel Clinical Research
    - 接触：
      
      电话号码：(702) 680-1500
  - Las Vegas、Nevada、美国、89119
    - 招聘中
    - Redbird Research
    - 接触：
      
      电话号码：(702) 577-2000
  - Las Vegas、Nevada、美国、89102
    - 招聘中
    - Ima Clinical Research - Las Vegas
    - 接触：
      
      电话号码：(702) 527-7401
  - Las Vegas、Nevada、美国、89118
    - 招聘中
    - Wake Research Las Vegas Rainbow
    - 接触：
      
      电话号码：(702) 893-8968
  - Las Vegas、Nevada、美国、89119
    - 招聘中
    - AMR Clinical - Las Vegas
    - 接触：
      
      电话号码：(702) 529-0153
  - North Las Vegas、Nevada、美国、89030
    - 招聘中
    - Las Vegas Clinical Trials
    - 接触：
      
      电话号码：(702) 637-3223
  - Reno、Nevada、美国、89511
    - 招聘中
    - Advanced Research Institute - Reno
    - 接触：
      
      电话号码：(775) 502-1616
- New Mexico
  - Albuquerque、New Mexico、美国、87102
    - 招聘中
    - Albuquerque Clinical Trials
    - 接触：
      
      电话号码：(505) 224-7407
- New York
  - Amherst、New York、美国、14226
    - 招聘中
    - Dent Neuro Institute, Buffalo
    - 接触：
      
      电话号码：(716) 250-2017
  - Brooklyn、New York、美国、11235
    - 招聘中
    - SPRI Clinical Trials, LLC
    - 接触：
      
      电话号码：(646) 747-4060
  - Commack、New York、美国、11725
    - 招聘中
    - True North Neurology
    - 接触：
      
      电话号码：(631) 364-9119
  - Manlius、New York、美国、13104
    - 招聘中
    - Central New York Clinical Research
    - 接触：
      
      电话号码：(315) 682-3263
  - New York、New York、美国、10017
    - 招聘中
    - Fieve Clinical Research, Inc
    - 接触：
      
      电话号码：(212) 772-3570
  - Rochester、New York、美国、14609
    - 招聘中
    - Rochester Clinical Research
    - 接触：
      
      电话号码：(585) 288-0890
  - Williamsville、New York、美国、14221
    - 招聘中
    - Upstate Clinical Research Associates
    - 接触：
      
      电话号码：(716) 626-6320
- North Carolina
  - Charlotte、North Carolina、美国、28277
    - 招聘中
    - Onsite Clinical Solutions
    - 接触：
      
      电话号码：(800) 785-3150
  - Greensboro、North Carolina、美国、27405
    - 招聘中
    - Headache Wellness Center
    - 接触：
      
      电话号码：(336) 574-8000
  - Greensboro、North Carolina、美国、27405
    - 招聘中
    - Guildford Neurologic Research Partners, LLC
    - 接触：
      
      电话号码：(336) 516-9103
  - Raleigh、North Carolina、美国、27607
    - 招聘中
    - Eximia Research - NC, LLC
    - 接触：
      
      电话号码：(919) 800-5154
  - Shelby、North Carolina、美国、28150
    - 招聘中
    - Carolina Research Center, Inc
    - 接触：
      
      电话号码：(704) 487-5228
- Ohio
  - Columbus、Ohio、美国、43228
    - 招聘中
    - Hometown Research
    - 接触：
      
      电话号码：(614) 362-3980
  - Milford、Ohio、美国、45150
    - 招聘中
    - Hometown Research
    - 接触：
      
      电话号码：(513) 831-5900
  - West Chester、Ohio、美国、45069
    - 招聘中
    - CincyScience
    - 接触：
      
      电话号码：(513) 646-4864
- Oklahoma
  - Edmond、Oklahoma、美国、73034
    - 招聘中
    - OK Clinical Research, LLC
    - 接触：
      
      电话号码：(405) 285-6811
  - Oklahoma City、Oklahoma、美国、73102
    - 招聘中
    - Hightower Clinical
    - 接触：
      
      电话号码：(405) 479-8331
  - Tulsa、Oklahoma、美国、74133
    - 招聘中
    - DelRicht Research
    - 接触：
      
      电话号码：(918) 932-2276
  - Yukon、Oklahoma、美国、73099
    - 招聘中
    - Tekton Research, Inc.
    - 接触：
      
      电话号码：(405) 281-3433
- Oregon
  - Portland、Oregon、美国、97210
    - 招聘中
    - Summit Research Network
    - 接触：
      
      电话号码：(855) 367-8834
  - Portland、Oregon、美国、97223
    - 招聘中
    - Advanced Research Institute - Portland
    - 接触：
      
      电话号码：(503) 610-0033
- Pennsylvania
  - Allentown、Pennsylvania、美国、18103
    - 招聘中
    - Lehigh Center For Clinical Research
    - 接触：
      
      电话号码：(818) 578-4555
  - Philadelphia、Pennsylvania、美国、19114
    - 招聘中
    - Clinical Research Philadelphia
    - 接触：
      
      电话号码：(215) 676-6696
  - Pittsburgh、Pennsylvania、美国、15236
    - 招聘中
    - Preferred Primary Care Physicians, Inc.
    - 接触：
      
      电话号码：(412) 650-6155
  - Scottdale、Pennsylvania、美国、15683
    - 招聘中
    - Frontier Clinical Research, LLC
    - 接触：
      
      电话号码：(724) 220-5281
  - Smithfield、Pennsylvania、美国、15478
    - 招聘中
    - Frontier Clinical Research, LLC
    - 接触：
      
      电话号码：(724) 569-8036
- South Carolina
  - North Charleston、South Carolina、美国、29405
    - 招聘中
    - Coastal Carolina Research Center
    - 接触：
      
      电话号码：(843) 856-3784
- Tennessee
  - Chattanooga、Tennessee、美国、37421
    - 招聘中
    - WR-ClinSearch, LLC
    - 接触：
      
      电话号码：(423) 698-4584
  - Nashville、Tennessee、美国、37203
    - 招聘中
    - Clinical Research Associates, Inc.
    - 接触：
      
      电话号码：(615) 329-0197
  - Nashville、Tennessee、美国、37203
    - 招聘中
    - Access Clinical Trials, Inc
    - 接触：
      
      电话号码：(615) 320-6076
- Texas
  - Austin、Texas、美国、78731
    - 招聘中
    - FutureSearch Trials of Neurology
    - 接触：
      
      电话号码：(512) 380-9925
  - Austin、Texas、美国、78745
    - 招聘中
    - Tekton Research
    - 接触：
      
      电话号码：(512) 859-3834
  - Cypress、Texas、美国、77372
    - 招聘中
    - APD Clinical Research
    - 接触：
      
      电话号码：(281) 315-4986
  - Cypress、Texas、美国、77429
    - 招聘中
    - Horizon Clinical Research and Gill Neuroscience
    - 接触：
      
      电话号码：(949) 491-0710
  - Dallas、Texas、美国、75251
    - 招聘中
    - FutureSearch Trials of Dallas, LP
    - 接触：
      
      电话号码：(214) 361-7700
  - Houston、Texas、美国、77081
    - 招聘中
    - DM Clinical Research
    - 接触：
      
      电话号码：(346) 550-9559
  - Houston、Texas、美国、77024
    - 招聘中
    - Victorium Clinical Research
    - 接触：
      
      电话号码：(832) 203-7026
  - Lampasas、Texas、美国、76550
    - 招聘中
    - GMG Clinical Research, LLC dba Radiance Clinical Research
    - 接触：
      
      电话号码：(512) 556-4130
  - Plano、Texas、美国、75093
    - 招聘中
    - AIM Trials, LLC
    - 接触：
      
      电话号码：(214) 856-2778
  - Waxahachie、Texas、美国、75165
    - 招聘中
    - ClinPoint Trials
    - 接触：
      
      电话号码：(972) 937-1640
- Utah
  - Bountiful、Utah、美国、84010
    - 招聘中
    - Pantheon Clinical Research
    - 接触：
      
      电话号码：(385) 281-0550
  - Draper、Utah、美国、84020
    - 招聘中
    - J. Lewis Research, Inc. / Foothill Family Clinic Draper
    - 接触：
      
      电话号码：3511 (801) 365-1032
  - Ogden、Utah、美国、84405
    - 招聘中
    - Advanced Research Institute
    - 接触：
      
      电话号码：(801) 409-2040
  - Riverton、Utah、美国、84096
    - 招聘中
    - Granger Medical Clinic
    - 接触：
      
      电话号码：(801) 302-1769
  - Salt Lake City、Utah、美国、84109
    - 招聘中
    - J. Lewis Research, Inc. / Foothill Family Clinic
    - 接触：
      
      电话号码：3315 (801) 486-3021
  - Salt Lake City、Utah、美国、84121
    - 招聘中
    - J. Lewis Research, Inc. / Foothill Family Clinic
    - 接触：
      
      电话号码：3538 (801) 365-1032
- Virginia
  - Newport News、Virginia、美国、23606
    - 招聘中
    - Health Research of Hampton Roads, Inc. (HRHR)
    - 接触：
      
      电话号码：(757) 591-8100
  - Norfolk、Virginia、美国、23502
    - 招聘中
    - AMR Clinical - Norfolk
    - 接触：
      
      电话号码：(757) 614-1001
- Washington
  - Seattle、Washington、美国、98104
    - 招聘中
    - Seattle Clinical Research Center
    - 接触：
      
      电话号码：(206) 522-3330
- West Virginia
  - Morgantown、West Virginia、美国、26505
    - 招聘中
    - Frontier Clinical Research
    - 接触：
      
      电话号码：(304) 241-1648
- Wisconsin
  - Kenosha、Wisconsin、美国、53144
    - 招聘中
    - Clinical Investigation Specialists, Inc.
    - 接触：
      
      电话号码：(847) 406-8080

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

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. 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:

A minimum of 12 months of spontaneous amenorrhea or
A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level > 40 mIU/mL or
At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant'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:

Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).
Intrauterine device (IUD);
Intrauterine hormone-releasing system (IUS);
Bilateral tubal occlusion;
Vasectomized partner;
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;
Male or female condom with or without spermicide;
Cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).

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:

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

Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.
Migraine history-related
Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.
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).
Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.
Was >50 years old at age of first migraine onset.
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
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].
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.
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.
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.
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.
Has a history of human immunodeficiency virus disease.
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 or may otherwise alter the absorption of orally administered drugs (e.g. upper gastrointestinal dysmotility).
Laboratory, vital sign, and electrocardiogram related
Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.
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.
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.
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.
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
Has known history of or suspected abuse of alcohol or recreational drugs at Screening.
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.
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.
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). Note: Any use of the following within 8 weeks of the screening visit, or anticipated use at any point during study participation are exclusionary:
1. Devices for the acute and/or preventative treatment of headache (migraine and/or other type of headache)
2. Nerve blocks and/or trigger point injections for the acute and/or preventative treatment of headache (migraine and/or other type of headache).
Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.
Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.
Other
Has known or suspected hypersensitivity to trial product(s) or related products.
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.
Has any surgery scheduled for the duration of the trial.
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).
Has previous participation in this trial. Participation is defined as signed informed consent.
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 P004. Note: Patients may not be screened at more than one trial site for this study.
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 participant's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.
Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：三倍

手臂数量

武器和干预

参与者组/臂	干预/治疗
安慰剂比较：安慰剂	药品：安慰剂口服给药
实验性的：Elismetrep 10 mg	药品：Elismetrep Administered orally 其他名称： K-304
实验性的：Elismetrep 20 mg	药品：Elismetrep Administered orally 其他名称： K-304

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Pain freedom at 2 hours post-dose 大体时间：Two hours post-dose	Percentage of participants that 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 大体时间：Two hours post-dose	Percentage of participants that 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

次要结果测量

结果测量	措施说明	大体时间
Pain relief at 2 hours post-dose 大体时间：Two hours post-dose	Percentage of participants that 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 48 hours post-dose 大体时间：From 2 to 48 hours post-dose	Percentage of participants that 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 48hours post-dose.	From 2 to 48 hours post-dose
Freedom from functional disability at 2 hours post-dose 大体时间：Two hours post-dose	Percentage of participants that self-report as being able to function normally on the functional disability scale in the subset of participants that 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
Pain relief at 60 minutes post-dose 大体时间：Sixty minutes post-dose	Percentage of participants that 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 60 minutes post-dose	Sixty minutes post-dose
Proportion requiring rescue medication within 24 hours post-dose 大体时间：Within 24 hours post-dose	Percentage of participants that take rescue medication within 24 hours post-dose.	Within 24 hours post-dose
Freedom from photophobia at 2 hours post-dose 大体时间：Two hours post-dose	Percentage of participants that report the absence of photophobia at 2 hours post-dose in the subset of participants that reported the presence of photophobia at baseline.	Two hours post-dose
Freedom from phonophobia at 2 hours post-dose 大体时间：Two hours post-dose	Percentage of participants that report the absence of phonophobia at 2 hours post-dose in the subset of participants that reported the presence of phonophobia at baseline.	Two hours post-dose
Freedom from nausea at 2 hours post-dose 大体时间：Two hours post-dose	Percentage of participants that report the absence of nausea at 2 hours post-dose in the subset of participants that reported the presence of nausea at baseline.	Two hours post-dose
Sustained pain freedom from 2 to 24 hours post-dose 大体时间：From 2 to 24 hours post-dose	Percentage of participants that 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 relief from 2 to 48 hours post-dose 大体时间：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
Sustained pain relief from 2 to 24 hours post-dose 大体时间：From 2 to 24 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 or 24 hours post-dose.	From 2 to 24 hours post-dose
Pain relapse from 2 to 48 hours post-dose 大体时间：From 2 to 48 hours post-dose	Percentage of participants that 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
Percentage of participants who experience one or more treatment-emergent adverse events (AEs) 大体时间：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) 大体时间：Up to 8 days post-dose		Up to 8 days post-dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kallyope Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月1日

初级完成 (估计的)

2027年2月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

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

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

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品