MigrainePhase 3NCT07816367
A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine
A Phase 3 study testing Elismetrep in people with Migraine, run by Kallyope Inc. at 72 sites in United States.
Trial summary
This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Migraine
- What is being tested?
- Elismetrep
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 72 sitesUnited States
- Study dates
- 2 Oct 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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 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.
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- 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). * 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.
Who cannot join
- Patients 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 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
- 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).
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- 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.
- 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).
- 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 P003. 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 subject'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. Note: Rescreening/retesting is not permitted unless specified above.
Trial locations and contacts
72 sites in 1 country. Contact the study team or a site near you to ask about taking part.
72 sites in 1 country
United States72 sites, 72 recruiting
- Recruiting
Accellacare - McFarland |
Ames, Iowa, 50010
Jennifer Killion, 515-956-4159, jkillion@mcfarlandclinic.com
- Recruiting
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Daniel Williams, 864-965-0190, dwilliams3@velocityclinical.com
- Recruiting
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, 30328
Frank Berenson, 678-705-7341, fberenson@pandaneuro.com
- Recruiting
Paradigm Clinical Research Centers, LLC; Aurora
Aurora, Colorado, 80012
Nathaniel Moore, 303-219-1830, nmoore@paradigm-research.com
- Recruiting
Central Texas Clinical Research
Austin, Texas, 78705
Cynthia Brinson, 512-480-9660, pi362@interspond.com
- Recruiting
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
Margaret Rhee, 216-682-0320, mrhee@velocityclinical.com
- Not yet recruiting
Gadolin Research, LLC
Beaumont, Texas, 77702
Kandasami Senthilkumar, 409-331-6040, ksenthilkumar@gadolin.com
- Not yet recruiting
Velocity Clinical Research, Cincinnati, Blue Ash
Blue Ash, Ohio, 45242
Audrius Ruksenas, 513-769-2767, aruksenas@velocityclinical.com
- Not yet recruiting
Paradigm Clinical Research Centers, LLC
Boise, Idaho, 83709
James Herrold, 208-801-7440, jherrold@paradigm-research.com
- Recruiting
Alliance Research Institute, Canoga Park
Canoga Park, California, 91304
Arash Matian, 818-835-9085, admatian@allianceri.org
- Recruiting
Accellacare - Cary (Cary Medical Group)
Cary, North Carolina, 27518
Sylvia Shoffner, 919-342-3447, sshoffner@carymedicalgroup.com
- Recruiting
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911
J Scott Overcash, 619-955-5246, sovercash@velocityclinical.com
- Recruiting
Headache Center of Hope
Cincinnati, Ohio, 45236
Hope O'Brien, 513-898-9400, drobrien@hcohcincy.com
- Recruiting
Centricity Research; Columbus, Ohio
Columbus, Ohio, 43213
Sridhar Guduri, 614-501-6164, Sridhar.Guduri@centricityresearch.com
- Recruiting
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
Jennifer Bashour, 682-348-1169, jbashour@velocityclinical.com
- Not yet recruiting
Centennial Clinical Trials
Denver, Colorado, 80246
Alan Shackelford, 650-995-4233, ashackleford@centennialclinicaltrials.com
- Not yet recruiting
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
Pritesh Patel, 972-777-6954, ppatel@epicmedresearch.com
- Recruiting
Newco 3A Researh LLC, DBA 3A Research
El Paso, Texas, 79902
Aldo Maspons, 915 598-8888, md.amaspons@gmail.com
- Not yet recruiting
NECCR PrimaCare Research, LLC
Fall River, Massachusetts, 02721
Ehab Sorial, 508-672-7450, esorial@neccr.com
- Recruiting
Lillestol Research
Fargo, North Dakota, 58104
Michael Lillestol, 701-232-7705, lillestolmd@lillestolresearch.com
- Not yet recruiting
Ark Clinical Research, Fountain Valley
Fountain Valley, California, 92708
Mark Leibowitz, 310-710-2985, pi1241@interspond.com
- Recruiting
Neurology Center of New England P.C.
Foxborough, Massachusetts, 02035
Salvatore Napoli, 781-551-5812 ext. 142, snapoli@neurocenterne.com
- Recruiting
Neurology Center of North Orange County
Fullerton, California, 92835
Anthony Ciabarra, 714-879-7200, drciabarra@gmail.com
- Not yet recruiting
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340
David Erb, 864-488-1283, derb@velocityclinical.com
- Not yet recruiting
Sun City Clinical Research
Glendale, Arizona, 85304
Jan Watson, 623-253-9777, jwatson@suncitytrials.com
- Not yet recruiting
Axiom Research, Los Angeles LLC
Glendale, California, 91206
Morgan Welebir, 909-824-2335, morganwelebir@axiomresearch.com
- Recruiting
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031
Luis Gonzalez-Orozco, 847-599-2492, lgonzalez@cisresearch.com
- Not yet recruiting
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009
Beth Safirstein, 954-455-5757, bsafirstein@velocityclinical.com
- Not yet recruiting
DM Clinical Research, Indianapolis
Indianapolis, Indiana, 46254
Brandon Essink, 463-271-3050, brandon.essink.ns@dmclinical.com
- Recruiting
Red Star Research
Lake Jackson, Texas, 77566
Harvey Resnick, 979-529-9440, resnick.redstarresearch@gmail.com
- Recruiting
Clinical Research of Central Florida
Lakeland, Florida, 33805
Cecilia Arango, 1-863-853-5400, jsmith@clinicalresearchcf.com
- Not yet recruiting
Oasis Clinical Research
Las Vegas, Nevada, 89121
Stephen Tam, 702-832-1369, stam@oasistrials.com
- Not yet recruiting
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Paul Wylie, 501-553-9987, pewyliemd1@outlook.com
- Recruiting
Long Beach Clinical Trials Services, Inc
Long Beach, California, 90806
Suzanne Fussell, 562-997-3869, sfussell@lbclinicaltrials.com
- Recruiting
Accellacare - Long Beach
Long Beach, California, 90807
Elizabeth Zarate-Rowell, 562-492-9966, Ezrtrials@gmail.com
- Not yet recruiting
Alliance Research Institute, Lynwood
Lynwood, California, 90262
Nijole Glaze, 818-835-9085, nglaze@allianceri.org
- Not yet recruiting
Indiana Medical Research Institute
Merrillville, Indiana, 46410
Arshad Malik, 219-207-5053, amalik@indianaclinicalresearch.com
- Not yet recruiting
AppleMedical Research Group, LLC
Miami, Florida, 33155
Agustin Latorre, 305-667-8434, dr.latorre@applemedresearch.org
- Not yet recruiting
Montana Medical Research, Inc
Missoula, Montana, 59808
Clancy Cone, 406-519-2132, ccone@montanamedicalresearch.com
- Recruiting
West Clinical Research
Morehead City, North Carolina, 28557
Patrick Morgante, 252-515-0050, patrick.morgante@westclinicalresearch.com
- Not yet recruiting
Evergreen Clinical Trials
Norcross, Georgia, 30092
Dmitriy Pelishev, 678-884-0550, dr.pelishev@evergreenstrials.com
- Not yet recruiting
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701
Charles Harper, 402-371-0797, charper@velocityclinical.com
- Not yet recruiting
Northridge Clinical Trials
Northridge, California, 91325
Sabreen Faqihi, 818-350-7483, sfaqihi@northridgetrials.com
- Recruiting
Sensible Healthcare, LLC
Ocoee, Florida, 34761
Kelly Taylor, 407-654-2724, drtaylor@sensiblehealthcare.net
- Not yet recruiting
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Ariana Bauer, 402-934-0044, bauer@qcrnetwork.com
- Recruiting
Clinical Associates of Orlando, LLC
Orlando, Florida, 32819
Anna Lizama Clark, 407-269-0322, alizama@clinicalassociatesorlando.com
- Not yet recruiting
Pasadena Clinical Trials
Pasadena, California, 91101
Tzu-Jen Tzao, 626-822-6554, ttzao@pasadenatrials.com
- Recruiting
Velocity Clinical Research, Phoenix
Phoenix, Arizona, 85006
C Stephen Plimpton, 602-368-1928, cplimpton@velocityclinical.com
- Recruiting
IMA Clinical Research - Phoenix
Phoenix, Arizona, 85012
Payam Sadr, 602-562-7000, payam.sadr@imaresearch.com
- Recruiting
Velocity Clinical Research, Providence
Providence, Rhode Island, 02818
David Fried, 401-739-9350 ext. 2333, dfried@velocityclinical.com
- Not yet recruiting
Accellacare - Raleigh (Raleigh Medical Group, P.A.)
Raleigh, North Carolina, 27609
John Rubino, 919-783-4895, jrubino@raleighmedicalgroup.com
- Not yet recruiting
Paradigm Clinical Research Centers, LLC
Redding, California, 96001
Sheila Finch, 530-247-7049, sfinch@paradigm-research.com
- Not yet recruiting
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
David Larsen, 801-288-0607, dlarsen@wasatchcrc.com
- Recruiting
Highland Clinical Research
Salt Lake City, Utah, 84124
Derek Muse, 801-559-3855, derekmuse@msn.com
- Recruiting
Clinical Trials of Texas, LLC, A Flourish Research Site
San Antonio, Texas, 78229
Parke Hedges, 210-949-0122 ext. 229, phedges@flourishresearch.com
- Not yet recruiting
San Antonio Clinical Trials
San Antonio, Texas, 78240
Dempsey Gordon Jr., 945-218-5593, dgordon@sanantoniotrials.com
- Not yet recruiting
Infinity Clinical Trials
San Diego, California, 92108
Jay Pandit, 619-704-0808, jpandit@infinityclinicalstudies.com
- Recruiting
Paradigm Clinical Research Centers, LLC
San Diego, California, 92108
Gary Boone, 858-274-4226, gboone@paradigm-research.com
- Recruiting
Optimus Medical Group
San Francisco, California, 94102
Shawn Hassler, 415-518-1292, shassler@studyops.com
- Not yet recruiting
Paragon Rx Clinical
Santa Ana, California, 92703
Kelvin Mai, 714-617-5689, Kelvin.Mai@prxclinical.com
- Not yet recruiting
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
Paul Bradley, 912-443-4253, pbradley@velocityclinical.com
- Not yet recruiting
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106
David Ensz, 712-639-6300, ensz@velocityclinical.com
- Not yet recruiting
Evanston Premier Healthcare Research, LLC
Skokie, Illinois, 60077
Jeffrey Geohas, 847-869-1191, jgeohas@evanstonpremier.com
- Not yet recruiting
Ki Health Partners, LLC
Stamford, Connecticut, 06905-1206
Peter Mcallister, 203-914-1900, peter@neinh.com
- Recruiting
DM Clinical Research, Sugar Land
Sugar Land, Texas, 77479
Irfan Lalani, 346-550-9559, irfan.lalani@dmclinical.com
- Recruiting
Cenexel Tampa FL
Tampa, Florida, 33613
Deborah White, 813-264-2155, d.white@cenexel.com
- Recruiting
DM Clinical Research, Tomball
Tomball, Texas, 77375
Muhammad Irfan, 281-517-0550, drirfan@dmclinical.com
- Not yet recruiting
Bio Behavioral Health
Toms River, New Jersey, 08755
Ashok Patel, 732-244-2299, ap@bbhnj.com
- Not yet recruiting
Velocity Clinical Research, Van Nuys
Van Nuys, California, 91606
Mark Turner, 818-487-3741, mturner@velocityclinical.com
- Not yet recruiting
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
Paul Winner, 561-845-0500, pwinner777@aol.com
- Recruiting
Accellacare - Wilmington
Wilmington, North Carolina, 28401
Kevin Cannon, 910-799-5500, Kevin.Cannon@accellacare.com
- Recruiting
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103
Mitchell Isaac, 336-768-8062, Mitchell.isaac2023@gmail.com
About this study
Official title: 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 safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.
- Conditions
- Migraine
- Being tested
- Elismetrep, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElismetrepDrug
Also called K-304
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Elismetrep 10 mg | Experimental | Participants received a single dose of elismetrep 10 mg Receives: Drug: Elismetrep |
| Elismetrep 20 mg | Experimental | Participants received a single dose of elismetrep 20 mg Receives: Drug: Elismetrep |
| Placebo | Placebo comparator | Participants received a single dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain freedom at 2 hours post-dose
Percentage of subjects who 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).
Measured: Two hours post-dose
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
Percentage of subjects who 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).
Measured: Two hours post-dose
Secondary outcomes (13)
Pain relief at 2 hours post-dose
Percentage of subjects who 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.
Measured: Two hours post-dose
Sustained pain freedom from 2 to 24 hours post-dose
Percentage of subjects who 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.
Measured: From 2 to 24 hours post-dose
Sustained pain freedom from 2 to 48 hours post-dose
Percentage of subjects who 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 48 hours post-dose.
Measured: From 2 to 48 hours post-dose
Sustained pain relief from 2 to 24 hours post-dose
Percentage of subjects who 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.
Measured: From 2 to 24 hours post-dose
Sustained pain relief 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.
Measured: From 2 to 48 hours post-dose
Freedom from functional disability at 2 hours post-dose
Percentage of subjects who self-report as being able to function normally on the functional disability scale in the subset of subjects who 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).
Measured: Two hours post-dose
Proportion requiring rescue medication within 24 hours post-dose
Percentage of subjects that take rescue medication within 24 hours post-dose.
Measured: Within 24 hours post-dose
Freedom from photophobia at 2 hours post-dose
Percentage of subjects who report the absence of photophobia at 2 hours post-dose in the subset of subjects who reported the presence of photophobia at baseline.
Measured: Two hours post-dose
Freedom from phonophobia at 2 hours post-dose
Percentage of subjects who report the absence of phonophobia at 2 hours post-dose in the subset of subjects who reported the presence of phonophobia at baseline.
Measured: Two hours post-dose
Freedom from nausea at 2 hours post-dose
Percentage of subjects who report the absence of nausea at 2 hours post-dose in the subset of subjects who reported the presence of nausea at baseline.
Measured: Two hours post-dose
Pain relapse from 2 to 48 hours post-dose
Percentage of subjects who 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.
Measured: From 2 to 48 hours post-dose
Percentage of participants who experience one or more treatment-emergent adverse events (AEs)
Measured: Up to 8 days post-dose
Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)
Measured: Up to 8 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start2 Oct 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kallyope Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816367
- Sponsor's protocol ID
- K-304 P004
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT07816367
- Acronym / sponsor ID
- K-304 P004
- Conditions
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Kallyope Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elismetrep 10 mg | Experimental | Drug: ElismetrepParticipants received a single dose of elismetrep 10 mg |
| Elismetrep 20 mg | Experimental | Drug: ElismetrepParticipants received a single dose of elismetrep 20 mg |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a single dose of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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
Key exclusion criteria (42 listed)
- 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
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElismetrepAlso: K-304Administered orally | Drug | Elismetrep 10 mg, Elismetrep 20 mg |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Pain freedom at 2 hours post-dose
Time frame: Two hours post-dose
Percentage of subjects who 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).
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
Time frame: Two hours post-dose
Percentage of subjects who 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).
13 secondary outcomes
Pain relief at 2 hours post-dose
Time frame: Two hours post-dose
Sustained pain freedom from 2 to 24 hours post-dose
Time frame: From 2 to 24 hours post-dose
Sustained pain freedom from 2 to 48 hours post-dose
Time frame: From 2 to 48 hours post-dose
Sustained pain relief from 2 to 24 hours post-dose
Time frame: From 2 to 24 hours post-dose
Sustained pain relief from 2 to 48 hours post-dose
Time frame: From 2 to 48 hours post-dose
Freedom from functional disability at 2 hours post-dose
Time frame: Two hours post-dose
Proportion requiring rescue medication within 24 hours post-dose
Time frame: Within 24 hours post-dose
Freedom from photophobia at 2 hours post-dose
Time frame: Two hours post-dose
Freedom from phonophobia at 2 hours post-dose
Time frame: Two hours post-dose
Freedom from nausea at 2 hours post-dose
Time frame: Two hours post-dose
Pain relapse from 2 to 48 hours post-dose
Time frame: From 2 to 48 hours post-dose
Percentage of participants who experience one or more treatment-emergent adverse events (AEs)
Time frame: Up to 8 days post-dose
Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)
Time frame: Up to 8 days post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elismetrep in people with Migraine, run by Kallyope Inc. at 72 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemarie Vance (917-336-3654, annemarie@kallyope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain freedom at 2 hours post-dose (time frame: Two hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.