A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine
NCT ID: NCT06848075
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
431 participants
INTERVENTIONAL
2025-03-05
2025-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Elismetrep (K-304) Dose level 1
Elismetrep (K-304) Dose Level 1
Administered orally
Elismetrep (K-304) Dose level 2
Elismetrep (K-304) Dose level 2
Administered orally
Elismetrep (K-304) Dose level 3
Elismetrep (K-304) Dose level 3
Administered orally
Elismetrep (K-304) Dose level 4
Elismetrep (K-304) Dose level 4
Administered orally
Placebo
Placebo
Administered orally
Interventions
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Elismetrep (K-304) Dose Level 1
Administered orally
Elismetrep (K-304) Dose level 2
Administered orally
Elismetrep (K-304) Dose level 3
Administered orally
Elismetrep (K-304) Dose level 4
Administered orally
Placebo
Administered orally
Eligibility Criteria
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Inclusion Criteria
2. Patient has greater than a one-year history of migraine with or without aura as defined by International Conference on Harmonization (IHS) 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 and confirmed by the investigator.
3. Patient has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to screening (Visit 1).
4. Meet the following requirements:
1. Is a male OR
2. Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
3. Postmenopausal (aged \>45 years and with a minimum of 12 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone (FSH) level in the menopausal range established for the central laboratory.
4. Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject's recall of their medical history.
OR
5. Is a female of reproductive potential and:
6. agrees to remain abstinent from heterosexual activity\*
\*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.
7. or 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 trial (EoT) visit. Acceptable methods of birth control are:
* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
* oral
* intravaginal
* transdermal
* progestogen-only hormonal contraception associated with inhibition of ovulation:
* oral
* injectable
* implantable
* intrauterine device (IUD)
* intrauterine hormone-releasing system (IUS)
* bilateral tubal occlusion
* vasectomised 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)
This condition is waived if the subject is proven to have no child-bearing potential (eg, hysterectomy).
5. Patient voluntarily agrees to participate in the study by giving written informed consent.
6. Patient is able to read, understand and complete the study questionnaires and diary.
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
Migraine history-related
2. Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches.
3. Patient has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours.
4. Patient 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 three months prior to screening (Visit 1).
5. Patient has brainstem (a.k.a. basilar-type) or hemiplegic migraine headache, or retinal migraine.
6. Patient was \>50 years old at age of first migraine onset.
7. Patient is taking migraine prophylactic medication where the prescribed daily 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. Patient 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. Patient 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, renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases 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. Patient 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 (MI), Acute Coronary Syndrome (ACS), percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
13. Has a history of human immunodeficiency virus disease.
14. Patient 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 (ECG) related
15. Has a positive test result at Screening for hepatitis B surface antigen (Ag), hepatitis C virus antibody.
16. Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with the Modification of Diet in Renal Disease (MDRD) equation of \<45 ml/min/1.73 m2.
17. Has a screening result for alanine aminotransferase or aspartate aminotransferase (ALT or AST) of \>2.0X upper limit of normal (ULN) or total bilirubin \>1.5X ULN at the Screening visit. Note: An isolated bilirubin \>1.5X ULN is acceptable if bilirubin is fractionated, and direct bilirubin is within the laboratory normal range.
18. Has a corrected QT interval to Fridericia's formula (QTcF) \>450 milliseconds (msec) for males and \>470 msec for females at screening.
19. Has a mean value for triplicate seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure (BP) \>95 mmHg measured after at least 5 minutes at rest at the Screening Visit.
Note: If a subject's BP is exclusionary on the first triplicate assessment at the Screening visit, they may have 1 repeat triplicate BP assessment at that visit after another rest of at least 10 minutes.
Medication use and substance abuse related
20. Has known history of or suspected abuse of alcohol or recreational drugs at Screening.
21. Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol (THC) or cannabidiol (CBD)) within 3 months prior to Screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to Screening.
22. Has a positive drug screen at Screening. Note: 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.
23. Is currently in violation of study requirements for prohibited and permissible concomitant medications (not already specified in other criteria) or is anticipated to violate these requirements during study participation.
24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
25. History of use of ergotamine medications on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months prior to screening.
26. History of non-narcotic analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months prior to screening.
Other
27. Has known or suspected hypersensitivity to trial product(s) or related products.
28. Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
29. Has any surgery scheduled for the duration of the trial.
30. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit; has a screening hemoglobin \<11.0 g/dL (males) or \<10.0 g/dL (females), or has a known hemoglobinopathy (e.g. sickle cell anemia, hemolytic anemia).
31. Has previous participation in this trial. Participation is defined as signed informed consent.
32. Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g. antibody therapy) within 90 days of Screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of Screening.
34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.
18 Years
70 Years
ALL
No
Sponsors
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Kallyope Inc.
INDUSTRY
Responsible Party
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Locations
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Central Research Associates, LLC (CRA) dba Flourish Research
Birmingham, Alabama, United States
AMR Mobile
Mobile, Alabama, United States
Wake Research/ Tucson Neuroscience Research
Tucson, Arizona, United States
Hope Clinical Research
Canoga Park, California, United States
WR-PRI, LLC (Encino)
Encino, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Eximia Research - CA
La Mesa, California, United States
Synergy San Diego
Lemon Grove, California, United States
WR-PRI, LLC (Newport Beach)
Newport Beach, California, United States
Excell Research, Inc.
Oceanside, California, United States
Empire Clinical Research
Pomona, California, United States
Artemis Institute for Clinical Research - Riverside
Riverside, California, United States
Acclaim Clinical Research
San Diego, California, United States
Artemis Institute for Clinical Research - San Diego
San Diego, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Focus Clinical Research
West Hills, California, United States
CT Clinical Research
Cromwell, Connecticut, United States
DelRicht Research
Atlanta, Georgia, United States
Clinical Research Atlanta - Stockbridge
Stockbridge, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Collective Medical Research
Overland Park, Kansas, United States
Alliance for Multispecialty Research
Wichita, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Crescent City Headache & Neurology Center
Chalmette, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
DelRicht Research
Gulfport, Mississippi, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Dent Neurosciences Research Center
Amherst, New York, United States
CNY Clinical Research
Manlius, New York, United States
Rochester Clinical Research
Rochester, New York, United States
Upstate Clinical Research Associates LLC
Williamsville, New York, United States
Headache Wellness Center
Greensboro, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
OK Clinical Research, LLC
Edmond, Oklahoma, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
DelRicht Research
Tulsa, Oklahoma, United States
Tekton Research
Yukon, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Atlas-Clinical
West Chester, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
WR-ClinSearch
Chattanooga, Tennessee, United States
AMR Knoxville (Formerly NOCCR)
Knoxville, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Donald J Garcia Jr, MD, PA
Austin, Texas, United States
Tekton Research
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Victorium Clinical Research LTD CO
Houston, Texas, United States
APD Clinical Research
Splendora, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Frontier Clinical Research, LLC
Morgantown, West Virginia, United States
Clinical Investigation Specialist
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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K-304 P001
Identifier Type: -
Identifier Source: org_study_id
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