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

NCT ID
NCT07816367
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Kallyope Inc.
Conditions
Migraine

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

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

Enrollment: 1500 participants (Estimated).

What is being studied

  • Drug: Elismetrep
  • Drug: Placebo

Who may be eligible

Ages
18 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

72 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Arizona, United States: 3
  • Arkansas, United States: 1
  • California, United States: 16
  • Colorado, United States: 2
  • Connecticut, United States: 1
  • Florida, United States: 7
  • Georgia, United States: 3
  • Idaho, United States: 1
  • Illinois, United States: 2
  • Indiana, United States: 2
  • Iowa, United States: 2
  • Massachusetts, United States: 2
  • Montana, United States: 1
  • Nebraska, United States: 2
  • Nevada, United States: 1
  • New Jersey, United States: 1
  • North Carolina, United States: 5
  • North Dakota, United States: 1
  • Ohio, United States: 4
  • Rhode Island, United States: 1
  • South Carolina, United States: 2
  • Texas, United States: 10
  • Utah, United States: 2

Sample of listed locations

  • Sun City Clinical Research — Glendale, Arizona, 85304, United States — Site recruitment status not specified in the registry data
  • IMA Clinical Research - Phoenix — Phoenix, Arizona, 85012, United States — Site recruitment status not specified in the registry data
  • Velocity Clinical Research, Phoenix — Phoenix, Arizona, 85006, United States — Site recruitment status not specified in the registry data
  • Preferred Research Partners, Inc. — Little Rock, Arkansas, 72211, United States — Site recruitment status not specified in the registry data
  • Alliance Research Institute, Canoga Park — Canoga Park, California, 91304, United States — Site recruitment status not specified in the registry data
  • Velocity Clinical Research, Chula Vista — Chula Vista, California, 91911, United States — Site recruitment status not specified in the registry data
  • Ark Clinical Research, Fountain Valley — Fountain Valley, California, 92708, United States — Site recruitment status not specified in the registry data
  • Neurology Center of North Orange County — Fullerton, California, 92835, United States — Site recruitment status not specified in the registry data
  • Axiom Research, Los Angeles LLC — Glendale, California, 91206, United States — Site recruitment status not specified in the registry data
  • Accellacare - Long Beach — Long Beach, California, 90807, United States — Site recruitment status not specified in the registry data
  • Long Beach Clinical Trials Services, Inc — Long Beach, California, 90806, United States — Site recruitment status not specified in the registry data
  • Alliance Research Institute, Lynwood — Lynwood, California, 90262, United States — Site recruitment status not specified in the registry data
  • Northridge Clinical Trials — Northridge, California, 91325, United States — Site recruitment status not specified in the registry data
  • Pasadena Clinical Trials — Pasadena, California, 91101, United States — Site recruitment status not specified in the registry data
  • Paradigm Clinical Research Centers, LLC — Redding, California, 96001, United States — Site recruitment status not specified in the registry data
  • Infinity Clinical Trials — San Diego, California, 92108, United States — Site recruitment status not specified in the registry data
  • Paradigm Clinical Research Centers, LLC — San Diego, California, 92108, United States — Site recruitment status not specified in the registry data
  • Optimus Medical Group — San Francisco, California, 94102, United States — Site recruitment status not specified in the registry data
  • Paragon Rx Clinical — Santa Ana, California, 92703, United States — Site recruitment status not specified in the registry data
  • Velocity Clinical Research, Van Nuys — Van Nuys, California, 91606, United States — Site recruitment status not specified in the registry data
  • Paradigm Clinical Research Centers, LLC; Aurora — Aurora, Colorado, 80012, United States — Site recruitment status not specified in the registry data
  • Centennial Clinical Trials — Denver, Colorado, 80246, United States — Site recruitment status not specified in the registry data
  • Ki Health Partners, LLC — Stamford, Connecticut, 06905-1206, United States — Site recruitment status not specified in the registry data
  • Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, 33009, United States — Site recruitment status not specified in the registry data
  • Clinical Research of Central Florida — Lakeland, Florida, 33805, United States — Site recruitment status not specified in the registry data

Study details

Start date
September 1, 2026
Primary completion date
September 1, 2027
Completion date
December 1, 2027
First posted
September 11, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07816367
Registry last updated
September 22, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07816367 on ClinicalTrials.gov

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