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 Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine

2026年8月26日 更新者：Kallyope Inc.
This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1000

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

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35205
        • 招聘中
        • Central Research Associates, LLC (CRA) dba Flourish Research
      • Mobile、Alabama、美国、36608
        • 招聘中
        • AMR Mobile
    • Arizona
      • Chandler、Arizona、美国、85286
        • 招聘中
        • TrialSphere
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • 招聘中
        • Arkansas Clinical Research
    • California
      • Colton、California、美国、92324
        • 招聘中
        • Axiom Research, LLC
      • Culver City、California、美国、90230
        • 招聘中
        • Proscience Research Group
      • Encino、California、美国、91316
        • 招聘中
        • Leading Edge Research LA, LLC
      • Irvine、California、美国、92604
        • 招聘中
        • Axiom Research, Orange County
      • Los Angeles、California、美国、90048
        • 招聘中
        • Clinical Research Institute
      • Los Angeles、California、美国、90017
        • 招聘中
        • Downtown L.A. Research Center, Inc.
      • Mission Viejo、California、美国、92691
        • 招聘中
        • M3 Wake Research - Mission Mental Health (WR-MMH)
      • Oceanside、California、美国、92056
        • 招聘中
        • Excell Research
      • Pomona、California、美国、91767
        • 招聘中
        • The Neurology Group
      • Pomona、California、美国、91767
        • 招聘中
        • Empire Clinical Research
      • Riverside、California、美国、92503
        • 招聘中
        • Artemis Institute for Clinical Research
      • San Diego、California、美国、92120
        • 招聘中
        • Acclaim Clinical Research
      • Sherman Oaks、California、美国、91403
        • 招聘中
        • CenExel Sherman Oaks CA (California Neuroscience Research)
      • Spring Valley、California、美国、91978
        • 招聘中
        • Encompass Clinical Research
      • Walnut Creek、California、美国、94598
        • 招聘中
        • Diablo Clinical Research
      • Walnut Creek、California、美国、94596
        • 招聘中
        • Sunwise Clinical Research
      • West Covina、California、美国、91790
        • 招聘中
        • Kinetic Clinical Research
      • West Hills、California、美国、91307
        • 招聘中
        • Focus Clinical Research
    • Colorado
      • Centennial、Colorado、美国、80112
        • 招聘中
        • IMMUNOe Research Centers
      • Colorado Springs、Colorado、美国、80910
        • 招聘中
        • MCB Clinical Research Centers
      • Fort Collins、Colorado、美国、80528
        • 招聘中
        • Advanced Neurosciences Research
    • Connecticut
      • Waterbury、Connecticut、美国、06708
        • 招聘中
        • Chase Medical Research, LLC
    • Georgia
      • Atlanta、Georgia、美国、30329
        • 招聘中
        • DelRicht Research
      • Marietta、Georgia、美国、30060
        • 招聘中
        • Drug Studies America
      • Stockbridge、Georgia、美国、30281
        • 招聘中
        • Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge
    • Illinois
      • Chicago、Illinois、美国、60607
        • 招聘中
        • Cedar Crosse Research Center
      • Chicago、Illinois、美国、60657
        • 招聘中
        • Chicago Headache Center & Research Institute
      • Flossmoor、Illinois、美国、60447
        • 招聘中
        • Healthcare Research Network II, LLC
      • Naperville、Illinois、美国、60563
        • 招聘中
        • Chicago Headache Center & Research Institute
    • Iowa
      • West Des Moines、Iowa、美国、50265
        • 招聘中
        • Integrated Clinical Trials Solution
    • Kansas
      • Overland Park、Kansas、美国、66214
        • 招聘中
        • Clinical Associates Midwest, LLC
      • Overland Park、Kansas、美国、66212
        • 招聘中
        • Collective Medical Research
      • Wichita、Kansas、美国、67207
        • 招聘中
        • Heartland Research Associates, LLC - An AMR Company
    • Kentucky
      • Bardstown、Kentucky、美国、40004
        • 招聘中
        • Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)
      • Lexington、Kentucky、美国、40509
        • 招聘中
        • AMR Clinical - Lexington
      • Lexington、Kentucky、美国、45212
        • 招聘中
        • CTI Clinical Research Center
    • Louisiana
      • Chalmette、Louisiana、美国、70043
        • 招聘中
        • Crescent City Headache & Neurology Center
      • New Orleans、Louisiana、美国、70115
        • 招聘中
        • DelRicht Research
    • Maryland
      • Pikesville、Maryland、美国、21208
        • 招聘中
        • Headlands Research - Pharmasite
    • Massachusetts
      • Boston、Massachusetts、美国、02131
        • 招聘中
        • Boston Clinical Trials - Alcanza
      • Waltham、Massachusetts、美国、02451
        • 招聘中
        • MedVadis Research Corporation, LLC
    • Michigan
      • Ann Arbor、Michigan、美国、48104
        • 招聘中
        • Michigan Headache Pain & Neurological Institute
    • Minnesota
      • Minneapolis、Minnesota、美国、55402
        • 招聘中
        • Clinical Research Institute
    • Mississippi
      • Gulfport、Mississippi、美国、39503
        • 招聘中
        • DelRicht Research
      • Ridgeland、Mississippi、美国、39157
        • 招聘中
        • Proven Endpoints
    • Missouri
      • City of Saint Peters、Missouri、美国、63303
        • 招聘中
        • StudyMetrix Research
      • Hazelwood、Missouri、美国、63042
        • 招聘中
        • Healthcare Research Network
      • Kansas City、Missouri、美国、64114
        • 招聘中
        • AMR Clinical - Kansas City
      • Springfield、Missouri、美国、65807
        • 招聘中
        • Clinvest Headlands Llc
      • St Louis、Missouri、美国、63141
        • 招聘中
        • Sundance Clinical Research
    • Nevada
      • Las Vegas、Nevada、美国、89109
        • 招聘中
        • Excel Clinical Research
      • Las Vegas、Nevada、美国、89119
        • 招聘中
        • Redbird Research
      • Las Vegas、Nevada、美国、89102
        • 招聘中
        • Ima Clinical Research - Las Vegas
      • Las Vegas、Nevada、美国、89118
        • 招聘中
        • Wake Research Las Vegas Rainbow
      • Las Vegas、Nevada、美国、89119
        • 招聘中
        • AMR Clinical - Las Vegas
      • North Las Vegas、Nevada、美国、89030
        • 招聘中
        • Las Vegas Clinical Trials
      • Reno、Nevada、美国、89511
        • 招聘中
        • Advanced Research Institute-Reno
    • New Mexico
      • Albuquerque、New Mexico、美国、87102
        • 招聘中
        • Albuquerque Clinical Trials
    • New York
      • Amherst、New York、美国、14226
        • 招聘中
        • Dent Neuro Institute, Buffalo
      • Brooklyn、New York、美国、11235
        • 招聘中
        • SPRI Clinical Trials, LLC
      • Commack、New York、美国、11725
        • 招聘中
        • True North Neurology
      • Manlius、New York、美国、13104
        • 招聘中
        • Central New York Clinical Research
      • New York、New York、美国、10017
        • 招聘中
        • Fieve Clinical Research, Inc
      • Rochester、New York、美国、14609
        • 招聘中
        • Rochester Clinical Research
      • Williamsville、New York、美国、14221
        • 招聘中
        • Upstate Clinical Research Associates
    • North Carolina
      • Charlotte、North Carolina、美国、28277
        • 招聘中
        • Onsite Clinical Solutions
      • Greensboro、North Carolina、美国、27405
        • 招聘中
        • Headache Wellness Center
      • Greensboro、North Carolina、美国、27405
        • 招聘中
        • Guilford Neurologic Research Partners, LLC
      • Raleigh、North Carolina、美国、27607
        • 招聘中
        • Eximia Research - NC, LLC
      • Shelby、North Carolina、美国、28150
        • 招聘中
        • Carolina Research Center, Inc
    • Ohio
      • Columbus、Ohio、美国、43228
        • 招聘中
        • Hometown Research
      • Milford、Ohio、美国、45150
        • 招聘中
        • Hometown Research
      • West Chester、Ohio、美国、45069
        • 招聘中
        • CincyScience
    • Oklahoma
      • Edmond、Oklahoma、美国、73034
        • 招聘中
        • OK Clinical Research, LLC
      • Oklahoma City、Oklahoma、美国、73102
        • 招聘中
        • Hightower Clinical
      • Tulsa、Oklahoma、美国、74133
        • 招聘中
        • DelRicht Research
      • Yukon、Oklahoma、美国、73099
        • 招聘中
        • Tekton Research, Inc.
    • Oregon
      • Portland、Oregon、美国、97210
        • 招聘中
        • Summit Research Network
      • Portland、Oregon、美国、97223
        • 招聘中
        • Advanced Research Institute-Portland
    • Pennsylvania
      • Allentown、Pennsylvania、美国、18103
        • 招聘中
        • Lehigh Center For Clinical Research
      • Philadelphia、Pennsylvania、美国、19114
        • 招聘中
        • Clinical Research Philadelphia
      • Pittsburgh、Pennsylvania、美国、15236
        • 招聘中
        • Preferred Primary Care Physicians, Inc.
      • Scottdale、Pennsylvania、美国、15683
        • 招聘中
        • Frontier Clinical Research, LLC
      • Smithfield、Pennsylvania、美国、15478
        • 招聘中
        • Frontier Clinical Research, LLC
    • South Carolina
      • North Charleston、South Carolina、美国、29405
        • 招聘中
        • Coastal Carolina Research Center
    • Tennessee
      • Chattanooga、Tennessee、美国、37421
        • 招聘中
        • WR-ClinSearch, LLC
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Clinical Research Associates, Inc.
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Access Clinical Trials Inc
    • Texas
      • Austin、Texas、美国、78731
        • 招聘中
        • FutureSearch Trials of Neurology
      • Austin、Texas、美国、78745
        • 招聘中
        • Tekton Research
      • Cypress、Texas、美国、77372
        • 招聘中
        • APD Clinical Research
      • Cypress、Texas、美国、77429
        • 招聘中
        • Horizon Clinical Research and Gill Neuroscience
      • Dallas、Texas、美国、75251
        • 招聘中
        • FutureSearch Trials of Dallas, LP
      • Houston、Texas、美国、77081
        • 招聘中
        • DM Clinical Research
      • Houston、Texas、美国、77024
        • 招聘中
        • Victorium Clinical Research
      • Lampasas、Texas、美国、76550
        • 招聘中
        • GMG Clinical Research, LLC dba Radiance Clinical Research
      • Plano、Texas、美国、75093
        • 招聘中
        • AIM Trials, LLC
      • Waxahachie、Texas、美国、75165
        • 招聘中
        • ClinPoint Trials
    • Utah
      • Bountiful、Utah、美国、84010
        • 招聘中
        • Pantheon Clinical Research
      • Draper、Utah、美国、84020
        • 招聘中
        • J. Lewis Research, Inc. / Foothill Family Clinic Draper
      • Ogden、Utah、美国、84405
        • 招聘中
        • Advanced Research Institute
      • Riverton、Utah、美国、84096
        • 招聘中
        • Granger Medical Clinic
      • Salt Lake City、Utah、美国、84109
        • 招聘中
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City、Utah、美国、84121
        • 招聘中
        • J. Lewis Research, Inc. / Foothill Family Clinic
    • Virginia
      • Newport News、Virginia、美国、23606
        • 招聘中
        • Health Research of Hampton Roads, Inc. (HRHR)
      • Norfolk、Virginia、美国、23502
        • 招聘中
        • AMR Clinical - Norfolk
    • Washington
      • Seattle、Washington、美国、98104
        • 招聘中
        • Seattle Clinical Research Center
    • West Virginia
      • Morgantown、West Virginia、美国、26505
        • 招聘中
        • Frontier Clinical Research
    • Wisconsin
      • Kenosha、Wisconsin、美国、53144
        • 招聘中
        • Clinical Investigation Specialists, Inc.

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. Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary.

    Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was <80%;

  2. Participant voluntarily agrees to participate in the study by giving written informed consent;
  3. Participant is able to read, understand, and complete the study questionnaires and diary;
  4. Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;
  5. Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study;
  6. For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the EoS visit.

Acceptable methods of birth control are:

i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence*; 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).

  • Abstinence can be used as the sole method of contraception if it is in line with the participant'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.

Exclusion Criteria:

  1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);
  2. Has, at the time of the base study EoS/Visit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);
  3. Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S/Visit 3, or of harm to others in the opinion of the investigator. Participants 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 'since last version' version of the C-SSRS;
  4. Participant 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 trial participation) as assessed for the base study E0S/Visit 3;
  5. Has any major surgery scheduled for the duration of the trial;
  6. Has any other 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 the interpretation of efficacy and/or safety results;
  7. At Visit 1, has an open/ongoing adverse event from the base study EoS visit;
  8. Experienced a serious adverse event in the base study;
  9. Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.

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

武器和干预

参与者组/臂
干预/治疗
实验性的：Elismetrep 10 mg
药品：安慰剂
口服给药
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
大体时间
Proportion of participants with at least one treatment-emergent adverse event (TEAE)
大体时间：Through study completion, an average of 1 year
Through study completion, an average of 1 year
Proportion of participants with at least one treatment-emergent serious adverse event (SAE)
大体时间：Through study completion, an average of 1 year
Through study completion, an average of 1 year
Proportion of participants with TEAEs leading to study drug discontinuation
大体时间：Through study completion, an average of 1 year
Through study completion, an average of 1 year
Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm
大体时间：Through study completion, an average of 1 year
Through study completion, an average of 1 year

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8月3日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月23日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • K-304 P005

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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