A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
2026년 8월 19일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
1800
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Annemarie Vance
- 전화번호: 917-336-3654
- 이메일: annemarie@kallyope.com
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35205
- 모병
- Central Research Associates, LLC (CRA) dba Flourish Research
-
연락하다:
- 전화번호: (205) 327-1077
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Mobile, Alabama, 미국, 36608
- 모병
- AMR Mobile
-
연락하다:
- 전화번호: (251) 901-2127
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Arizona
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Chandler, Arizona, 미국, 85286
- 모병
- TrialSphere
-
연락하다:
- 전화번호: (623) 267-8314
-
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Arkansas
-
Little Rock, Arkansas, 미국, 72205
- 모병
- Arkansas Clinical Research
-
연락하다:
- 전화번호: (501) 480-5088
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California
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Colton, California, 미국, 92324
- 모병
- Axiom Research, LLC
-
연락하다:
- 전화번호: (909) 824-2325
-
Culver City, California, 미국, 90230
- 모병
- Proscience Research Group
-
연락하다:
- 전화번호: (424) 227-8127
-
Encino, California, 미국, 91316
- 모병
- Leading Edge Research LA, LLC
-
연락하다:
- 전화번호: (818) 578-4555
-
Irvine, California, 미국, 92604
- 모병
- Axiom Research, Orange County
-
연락하다:
- 전화번호: (909) 824-2325
-
Los Angeles, California, 미국, 90048
- 모병
- Clinical Research Institute
-
연락하다:
- 전화번호: (323) 879-9999
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Los Angeles, California, 미국, 90017
- 모병
- Downtown L.A. Research Center, Inc.
-
연락하다:
- 전화번호: (213) 261-3680
-
Mission Viejo, California, 미국, 92691
- 모병
- M3 Wake Research - Mission Mental Health (WR-MMH)
-
연락하다:
- 전화번호: (949) 752-7910
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Oceanside, California, 미국, 92056
- 모병
- Excell Research
-
연락하다:
- 전화번호: (760) 758-2222
-
Pomona, California, 미국, 91767
- 모병
- The Neurology Group
-
연락하다:
- 전화번호: 603 (909) 982-2719
-
Pomona, California, 미국, 91767
- 모병
- Empire Clinical Research
-
연락하다:
- 전화번호: (909) 981-5321
-
Riverside, California, 미국, 92503
- 모병
- Artemis Institute for Clinical Research
-
연락하다:
- 전화번호: (855) 367-8834
-
San Diego, California, 미국, 92120
- 모병
- Acclaim Clinical Research
-
연락하다:
- 전화번호: (855) 367-8834
-
Sherman Oaks, California, 미국, 91403
- 모병
- CenExel Sherman Oaks CA (California Neuroscience Research)
-
연락하다:
- 전화번호: (818) 990-2671
-
Spring Valley, California, 미국, 91978
- 모병
- Encompass Clinical Research
-
연락하다:
- 전화번호: (619) 660-9068
-
Walnut Creek, California, 미국, 94598
- 모병
- Diablo Clinical Research
-
연락하다:
- 전화번호: (925) 930-7267
-
Walnut Creek, California, 미국, 94596
- 모병
- Sunwise Clinical Research
-
연락하다:
- 전화번호: (925) 298-5147
-
West Covina, California, 미국, 91790
- 모병
- Kinetic Clinical Research
-
연락하다:
- 전화번호: (657) 230-7120
-
West Hills, California, 미국, 91307
- 모병
- Focus Clinical Research
-
연락하다:
- 전화번호: (818) 253-8966
-
-
Colorado
-
Centennial, Colorado, 미국, 80112
- 모병
- IMMUNOe Research Centers
-
연락하다:
- 전화번호: (303) 771-9000
-
Colorado Springs, Colorado, 미국, 80910
- 모병
- MCB Clinical Research Centers
-
연락하다:
- 전화번호: (719) 634-6576
-
Fort Collins, Colorado, 미국, 80528
- 모병
- Advanced Neurosciences Research
-
연락하다:
- 전화번호: (970) 226-6111
-
-
Connecticut
-
Waterbury, Connecticut, 미국, 06708
- 모병
- Chase Medical Research, LLC
-
연락하다:
- 전화번호: (203) 419-4404
-
-
Georgia
-
Atlanta, Georgia, 미국, 30329
- 모병
- DelRicht Research
-
연락하다:
- 전화번호: (770) 417-4454
-
Marietta, Georgia, 미국, 30060
- 모병
- Drug Studies America
-
연락하다:
- 전화번호: (678) 581-5252
-
Stockbridge, Georgia, 미국, 30281
- 모병
- Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
-
연락하다:
- 전화번호: (770) 626-0177
-
-
Illinois
-
Chicago, Illinois, 미국, 60607
- 모병
- Cedar Crosse Research Center
-
연락하다:
- 전화번호: (312) 431-6780
-
Chicago, Illinois, 미국, 60657
- 모병
- Chicago Headache Center & Research Institute
-
연락하다:
- 전화번호: (773) 935-1000
-
Flossmoor, Illinois, 미국, 60477
- 모병
- Healthcare Research Network II, LLC
-
연락하다:
- 전화번호: (708) 388-2245
-
Naperville, Illinois, 미국, 60563
- 모병
- Chicago Headache Center & Research Institute
-
연락하다:
- 전화번호: (415) 397-0700
-
-
Iowa
-
West Des Moines, Iowa, 미국, 50265
- 모병
- Integrated Clinical Trials Solution
-
연락하다:
- 전화번호: (515) 223-2300
-
-
Kansas
-
Overland Park, Kansas, 미국, 66214
- 모병
- Clinical Associates Midwest, LLC
-
연락하다:
- 전화번호: (913) 359-5699
-
Overland Park, Kansas, 미국, 66212
- 모병
- Collective Medical Research
-
연락하다:
- 전화번호: (913) 381-7180
-
Wichita, Kansas, 미국, 67207
- 모병
- Heartland Research Associates, LLC - An AMR Company
-
연락하다:
- 전화번호: (316) 689-6635
-
-
Kentucky
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Bardstown, Kentucky, 미국, 40004
- 모병
- Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
-
연락하다:
- 전화번호: (502) 349-1569
-
Lexington, Kentucky, 미국, 40509
- 모병
- AMR Clinical - Lexington
-
연락하다:
- 전화번호: (859) 264-8999
-
Lexington, Kentucky, 미국, 45212
- 모병
- CTI Clinical Research Center
-
연락하다:
- 전화번호: (513) 721-3868
-
-
Louisiana
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Chalmette, Louisiana, 미국, 70043
- 모병
- Crescent City Headache & Neurology Center
-
연락하다:
- 전화번호: (504) 418-6040
-
New Orleans, Louisiana, 미국, 70115
- 모병
- DelRicht Research
-
연락하다:
- 전화번호: (504) 336-2667
-
-
Maryland
-
Pikesville, Maryland, 미국, 21208
- 모병
- Headlands Research - Pharmasite
-
연락하다:
- 전화번호: (410) 602-1440
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02131
- 모병
- Boston Clinical Trials - Alcanza
-
연락하다:
- 전화번호: (843) 856-3784
-
Waltham, Massachusetts, 미국, 02451
- 모병
- MedVadis Research Corporation, LLC
-
연락하다:
- 전화번호: (781) 373-2940
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48104
- 모병
- Michigan Headache Pain & Neurological Institute
-
연락하다:
- 전화번호: Option 4 (734) 677-6000
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55402
- 모병
- Clinical Research Institute
-
연락하다:
- 전화번호: 5 (612) 333-2200
-
-
Mississippi
-
Gulfport, Mississippi, 미국, 39503
- 모병
- DelRicht Research
-
연락하다:
- 전화번호: (228) 588-8268
-
Ridgeland, Mississippi, 미국, 39157
- 모병
- Proven Endpoints
-
연락하다:
- 전화번호: (601) 790-1811
-
-
Missouri
-
City of Saint Peters, Missouri, 미국, 63303
- 모병
- StudyMetrix Research
-
연락하다:
- 전화번호: (636) 387-5100
-
Hazelwood, Missouri, 미국, 63042
- 모병
- Healthcare Research Network
-
연락하다:
- 전화번호: (314) 972-9600
-
Kansas City, Missouri, 미국, 64114
- 모병
- AMR Clinical - Kansas City
-
연락하다:
- 전화번호: (816) 643-4153
-
Springfield, Missouri, 미국, 65807
- 모병
- Clinvest Headlands Llc
-
연락하다:
- 전화번호: (417) 883-7889
-
St Louis, Missouri, 미국, 63141
- 모병
- Sundance Clinical Research
-
연락하다:
- 전화번호: (314) 567-3377
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89109
- 모병
- Excel Clinical Research
-
연락하다:
- 전화번호: (702) 680-1500
-
Las Vegas, Nevada, 미국, 89119
- 모병
- Redbird Research
-
연락하다:
- 전화번호: (702) 577-2000
-
Las Vegas, Nevada, 미국, 89102
- 모병
- Ima Clinical Research - Las Vegas
-
연락하다:
- 전화번호: (702) 527-7401
-
Las Vegas, Nevada, 미국, 89118
- 모병
- Wake Research Las Vegas Rainbow
-
연락하다:
- 전화번호: (702) 893-8968
-
Las Vegas, Nevada, 미국, 89119
- 모병
- AMR Clinical - Las Vegas
-
연락하다:
- 전화번호: (702) 529-0153
-
North Las Vegas, Nevada, 미국, 89030
- 모병
- Las Vegas Clinical Trials
-
연락하다:
- 전화번호: (702) 637-3223
-
Reno, Nevada, 미국, 89511
- 모병
- Advanced Research Institute - Reno
-
연락하다:
- 전화번호: (775) 502-1616
-
-
New Mexico
-
Albuquerque, New Mexico, 미국, 87102
- 모병
- Albuquerque Clinical Trials
-
연락하다:
- 전화번호: (505) 224-7407
-
-
New York
-
Amherst, New York, 미국, 14226
- 모병
- Dent Neuro Institute, Buffalo
-
연락하다:
- 전화번호: (716) 250-2017
-
Brooklyn, New York, 미국, 11235
- 모병
- SPRI Clinical Trials, LLC
-
연락하다:
- 전화번호: (646) 747-4060
-
Commack, New York, 미국, 11725
- 모병
- True North Neurology
-
연락하다:
- 전화번호: (631) 364-9119
-
Manlius, New York, 미국, 13104
- 모병
- Central New York Clinical Research
-
연락하다:
- 전화번호: (315) 682-3263
-
New York, New York, 미국, 10017
- 모병
- Fieve Clinical Research, Inc
-
연락하다:
- 전화번호: (212) 772-3570
-
Rochester, New York, 미국, 14609
- 모병
- Rochester Clinical Research
-
연락하다:
- 전화번호: (585) 288-0890
-
Williamsville, New York, 미국, 14221
- 모병
- Upstate Clinical Research Associates
-
연락하다:
- 전화번호: (716) 626-6320
-
-
North Carolina
-
Charlotte, North Carolina, 미국, 28277
- 모병
- Onsite Clinical Solutions
-
연락하다:
- 전화번호: (800) 785-3150
-
Greensboro, North Carolina, 미국, 27405
- 모병
- Headache Wellness Center
-
연락하다:
- 전화번호: (336) 574-8000
-
Greensboro, North Carolina, 미국, 27405
- 모병
- Guildford Neurologic Research Partners, LLC
-
연락하다:
- 전화번호: (336) 516-9103
-
Raleigh, North Carolina, 미국, 27607
- 모병
- Eximia Research - NC, LLC
-
연락하다:
- 전화번호: (919) 800-5154
-
Shelby, North Carolina, 미국, 28150
- 모병
- Carolina Research Center, Inc
-
연락하다:
- 전화번호: (704) 487-5228
-
-
Ohio
-
Columbus, Ohio, 미국, 43228
- 모병
- Hometown Research
-
연락하다:
- 전화번호: (614) 362-3980
-
Milford, Ohio, 미국, 45150
- 모병
- Hometown Research
-
연락하다:
- 전화번호: (513) 831-5900
-
West Chester, Ohio, 미국, 45069
- 모병
- CincyScience
-
연락하다:
- 전화번호: (513) 646-4864
-
-
Oklahoma
-
Edmond, Oklahoma, 미국, 73034
- 모병
- OK Clinical Research, LLC
-
연락하다:
- 전화번호: (405) 285-6811
-
Oklahoma City, Oklahoma, 미국, 73102
- 모병
- Hightower Clinical
-
연락하다:
- 전화번호: (405) 479-8331
-
Tulsa, Oklahoma, 미국, 74133
- 모병
- DelRicht Research
-
연락하다:
- 전화번호: (918) 932-2276
-
Yukon, Oklahoma, 미국, 73099
- 모병
- Tekton Research, Inc.
-
연락하다:
- 전화번호: (405) 281-3433
-
-
Oregon
-
Portland, Oregon, 미국, 97210
- 모병
- Summit Research Network
-
연락하다:
- 전화번호: (855) 367-8834
-
Portland, Oregon, 미국, 97223
- 모병
- Advanced Research Institute - Portland
-
연락하다:
- 전화번호: (503) 610-0033
-
-
Pennsylvania
-
Allentown, Pennsylvania, 미국, 18103
- 모병
- Lehigh Center For Clinical Research
-
연락하다:
- 전화번호: (818) 578-4555
-
Philadelphia, Pennsylvania, 미국, 19114
- 모병
- Clinical Research Philadelphia
-
연락하다:
- 전화번호: (215) 676-6696
-
Pittsburgh, Pennsylvania, 미국, 15236
- 모병
- Preferred Primary Care Physicians, Inc.
-
연락하다:
- 전화번호: (412) 650-6155
-
Scottdale, Pennsylvania, 미국, 15683
- 모병
- Frontier Clinical Research, LLC
-
연락하다:
- 전화번호: (724) 220-5281
-
Smithfield, Pennsylvania, 미국, 15478
- 모병
- Frontier Clinical Research, LLC
-
연락하다:
- 전화번호: (724) 569-8036
-
-
South Carolina
-
North Charleston, South Carolina, 미국, 29405
- 모병
- Coastal Carolina Research Center
-
연락하다:
- 전화번호: (843) 856-3784
-
-
Tennessee
-
Chattanooga, Tennessee, 미국, 37421
- 모병
- WR-ClinSearch, LLC
-
연락하다:
- 전화번호: (423) 698-4584
-
Nashville, Tennessee, 미국, 37203
- 모병
- Clinical Research Associates, Inc.
-
연락하다:
- 전화번호: (615) 329-0197
-
Nashville, Tennessee, 미국, 37203
- 모병
- Access Clinical Trials, Inc
-
연락하다:
- 전화번호: (615) 320-6076
-
-
Texas
-
Austin, Texas, 미국, 78731
- 모병
- FutureSearch Trials of Neurology
-
연락하다:
- 전화번호: (512) 380-9925
-
Austin, Texas, 미국, 78745
- 모병
- Tekton Research
-
연락하다:
- 전화번호: (512) 859-3834
-
Cypress, Texas, 미국, 77372
- 모병
- APD Clinical Research
-
연락하다:
- 전화번호: (281) 315-4986
-
Cypress, Texas, 미국, 77429
- 모병
- Horizon Clinical Research and Gill Neuroscience
-
연락하다:
- 전화번호: (949) 491-0710
-
Dallas, Texas, 미국, 75251
- 모병
- FutureSearch Trials of Dallas, LP
-
연락하다:
- 전화번호: (214) 361-7700
-
Houston, Texas, 미국, 77081
- 모병
- DM Clinical Research
-
연락하다:
- 전화번호: (346) 550-9559
-
Houston, Texas, 미국, 77024
- 모병
- Victorium Clinical Research
-
연락하다:
- 전화번호: (832) 203-7026
-
Lampasas, Texas, 미국, 76550
- 모병
- GMG Clinical Research, LLC dba Radiance Clinical Research
-
연락하다:
- 전화번호: (512) 556-4130
-
Plano, Texas, 미국, 75093
- 모병
- AIM Trials, LLC
-
연락하다:
- 전화번호: (214) 856-2778
-
Waxahachie, Texas, 미국, 75165
- 모병
- ClinPoint Trials
-
연락하다:
- 전화번호: (972) 937-1640
-
-
Utah
-
Bountiful, Utah, 미국, 84010
- 모병
- Pantheon Clinical Research
-
연락하다:
- 전화번호: (385) 281-0550
-
Draper, Utah, 미국, 84020
- 모병
- J. Lewis Research, Inc. / Foothill Family Clinic Draper
-
연락하다:
- 전화번호: 3511 (801) 365-1032
-
Ogden, Utah, 미국, 84405
- 모병
- Advanced Research Institute
-
연락하다:
- 전화번호: (801) 409-2040
-
Riverton, Utah, 미국, 84096
- 모병
- Granger Medical Clinic
-
연락하다:
- 전화번호: (801) 302-1769
-
Salt Lake City, Utah, 미국, 84109
- 모병
- J. Lewis Research, Inc. / Foothill Family Clinic
-
연락하다:
- 전화번호: 3315 (801) 486-3021
-
Salt Lake City, Utah, 미국, 84121
- 모병
- J. Lewis Research, Inc. / Foothill Family Clinic
-
연락하다:
- 전화번호: 3538 (801) 365-1032
-
-
Virginia
-
Newport News, Virginia, 미국, 23606
- 모병
- Health Research of Hampton Roads, Inc. (HRHR)
-
연락하다:
- 전화번호: (757) 591-8100
-
Norfolk, Virginia, 미국, 23502
- 모병
- AMR Clinical - Norfolk
-
연락하다:
- 전화번호: (757) 614-1001
-
-
Washington
-
Seattle, Washington, 미국, 98104
- 모병
- Seattle Clinical Research Center
-
연락하다:
- 전화번호: (206) 522-3330
-
-
West Virginia
-
Morgantown, West Virginia, 미국, 26505
- 모병
- Frontier Clinical Research
-
연락하다:
- 전화번호: (304) 241-1648
-
-
Wisconsin
-
Kenosha, Wisconsin, 미국, 53144
- 모병
- Clinical Investigation Specialists, Inc.
-
연락하다:
- 전화번호: (847) 406-8080
-
-
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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:
- 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.
- 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:
- Devices for the acute and/or preventative treatment of headache (migraine and/or other type of headache)
- 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.
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 위약
|
구두로 관리
|
|
실험적: Elismetrep 10 mg
|
Administered orally
다른 이름들:
|
|
실험적: Elismetrep 20 mg
|
Administered orally
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain freedom at 2 hours post-dose
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain relief at 2 hours post-dose
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: Up to 8 days post-dose
|
Up to 8 days post-dose
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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)
2026년 7월 1일
기본 완료 (추정된)
2027년 2월 1일
연구 완료 (추정된)
2027년 2월 1일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 19일
마지막으로 확인됨
2026년 8월 1일
추가 정보
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. .