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MigrainePhase 2NCT06848075

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

A Phase 2 study testing Elismetrep (K-304) 2 mg, Elismetrep (K-304) 5 mg and Elismetrep (K-304) 10 mg in people with Migraine, run by Kallyope Inc. at 66 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the acute treatment of migraine. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Migraine
What is being tested?
Elismetrep (K-304) 2 mg, Elismetrep (K-304) 5 mg and Elismetrep (K-304) 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
431 participants
Where
66 sitesUnited States
Study dates
11 Mar 2025to 4 Aug 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be a male or female, age 18 to 70 years, inclusive, at the time of signing informed consent.
  • Participant 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 participant's medical records from his/her treating physician and confirmed by the investigator.
  • Participant has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to screening (Visit 1).
  • Meet the following requirements:
  • Is a male OR
  • Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
Show all 35Show fewer
  • 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.
  • Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the participant's recall of their medical history.
  • OR
  • Is a female of reproductive potential and:
  • agrees to remain abstinent from heterosexual activity*
  • 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.
  • 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 participant is proven to have no child-bearing potential (eg, hysterectomy).
  • Participant voluntarily agrees to participate in the study by giving written informed consent.
  • Participant is able to read, understand and complete the study questionnaires and diary.
  • Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions.
  • Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.

Who cannot join

  • 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 serum pregnancy test (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.
  • Migraine history related
  • Participant has difficulty distinguishing his/her migraine attacks from tension-type headaches.
  • Participant has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours.
  • Participant 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).
  • Participant has brainstem (a.k.a. basilar-type) or hemiplegic migraine headache, or retinal migraine.
Show all 40Show fewer
  • Participant was >50 years old at age of first migraine onset.
  • Participant 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
  • Participant 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 [participants 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].
  • Participant 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. 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 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, renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases that, per the investigator's judgement, may jeopardize the participant'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.
  • Participant history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Participants 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.
  • Has a history of human immunodeficiency virus disease.
  • Participant 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
  • Has a positive test result at screening for hepatitis B surface antigen (Ag), hepatitis C virus antibody.
  • 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 m^2.
  • 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.
  • Has a corrected QT interval to Fridericia's formula (QTcF) >450 milliseconds (msec) for males and >470 msec for females at screening.
  • 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 participant'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
  • 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.
  • 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.
  • Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
  • 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.
  • History of non-narcotic analgesic intake on greater than/equal 15 days per month for greater than/equal 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.
  • 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).
  • 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.
  • 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.

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18103

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • DelRicht Research

    Atlanta, Georgia, 30329

  • Donald J Garcia Jr, MD, PA

    Austin, Texas, 78737

  • Tekton Research

    Austin, Texas, 78745

  • Central Research Associates, LLC (CRA) dba Flourish Research

    Birmingham, Alabama, 35205

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Crescent City Headache & Neurology Center

    Chalmette, Louisiana, 70043

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • WR-ClinSearch

    Chattanooga, Tennessee, 37421

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • CT Clinical Research

    Cromwell, Connecticut, 06416

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75251

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034

  • WR-PRI, LLC (Encino)

    Encino, California, 91316

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois, 60422

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

  • DelRicht Research

    Gulfport, Mississippi, 39503

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • Peters Medical Research

    High Point, North Carolina, 27260

  • Victorium Clinical Research LTD CO

    Houston, Texas, 77024

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Clinical Investigation Specialist

    Kenosha, Wisconsin, 53144

  • AMR Knoxville (Formerly NOCCR)

    Knoxville, Tennessee, 37909

  • Eximia Research - CA

    La Mesa, California, 91942

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Synergy San Diego

    Lemon Grove, California, 91945

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • CNY Clinical Research

    Manlius, New York, 13104

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • AMR Mobile

    Mobile, Alabama, 36608

  • Frontier Clinical Research, LLC

    Morgantown, West Virginia, 26505

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • WR-PRI, LLC (Newport Beach)

    Newport Beach, California, 92660

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Las Vegas Clinical Trials

    North Las Vegas, Nevada, 89119

  • Excell Research, Inc.

    Oceanside, California, 92056

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • Collective Medical Research

    Overland Park, Kansas, 66202

  • Clinical Research Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Empire Clinical Research

    Pomona, California, 91767

  • Summit Research Network

    Portland, Oregon, 97210

  • Artemis Institute for Clinical Research - Riverside

    Riverside, California, 92503

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Acclaim Clinical Research

    San Diego, California, 89109

  • Artemis Institute for Clinical Research - San Diego

    San Diego, California, 92103

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • APD Clinical Research

    Splendora, Texas, 77372

  • Clinical Research Atlanta - Stockbridge

    Stockbridge, Georgia, 30281

  • Wake Research/ Tucson Neuroscience Research

    Tucson, Arizona, 85710

  • DelRicht Research

    Tulsa, Oklahoma, 74133

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • ClinPoint Trials

    Waxahachie, Texas, 75165

  • Atlas-Clinical

    West Chester, Pennsylvania, 19380

  • Focus Clinical Research

    West Hills, California, 91307

  • Alliance for Multispecialty Research

    Wichita, Kansas, 67207

  • Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221

  • Tekton Research

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

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

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the acute treatment of migraine.

Conditions
Migraine
Being tested
Elismetrep (K-304) 2 mg, Elismetrep (K-304) 5 mg, Elismetrep (K-304) 10 mg, Elismetrep (K-304) 20 mg, 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.

  • Elismetrep (K-304) 2 mgDrug

    Administered orally

  • Elismetrep (K-304) 5 mgDrug

    Administered orally

  • Elismetrep (K-304) 10 mgDrug

    Administered orally

  • Elismetrep (K-304) 20 mgDrug

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT06848075
Study groupRoleWhat they receive
Elismetrep (K-304) Dose Level 1ExperimentalParticipants received a single dose of elismetrep 2 mg
Receives: Drug: Elismetrep (K-304) 2 mg
Elismetrep (K-304) Dose Level 2ExperimentalParticipants received a single dose of elismetrep 5 mg
Receives: Drug: Elismetrep (K-304) 5 mg
Elismetrep (K-304) Dose Level 3ExperimentalParticipants received a single dose of elismetrep 10 mg
Receives: Drug: Elismetrep (K-304) 10 mg
Elismetrep (K-304) Dose Level 4ExperimentalParticipants received a single dose of elismetrep 20 mg
Receives: Drug: Elismetrep (K-304) 20 mg
PlaceboPlacebo comparatorParticipants received a single dose of elismetrep-matched placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Freedom

    Assessed using the number of evaluable participants that reported no pain at 2 hours post-dose. Pain was measured on a 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe)

    Measured: 2 hours post-dose

Secondary outcomes (12)

  1. Freedom From the Most Bothersome Symptom (MBS) (Nausea, Phonophobia or Photophobia)

    Assessed using the number of evaluable participants that reported the absence of their MBS

    Measured: 2 hours post-dose

  2. Pain Relief

    Assessed using the number of evaluable participants that reported a pain level of moderate or severe (responses of 2 or 3 on the 4-point Likert scale) at baseline and then reported a pain level of none or mild (response of 0 or 1).

    Measured: 2 hours post-dose

  3. Freedom From Photophobia

    Assessed by tabulating the number of participants that reported the absence of photophobia at 2 hours post-dose in the subset of participants that reported the presence of photophobia at baseline.

    Measured: 2 hours post-dose

  4. Freedom From Phonophobia

    Assessed by tabulating the number of participants that reported the absence of phonophobia at 2 hours post-dose in the subset of participants that reported the presence of phonophobia at baseline.

    Measured: 2 hours post-dose

  5. Freedom From Nausea

    Assessed by tabulating the number of participants that reported the absence of nausea at 2 hours post-dose in the subset of participants that reported the presence of nausea at baseline.

    Measured: 2 hours post-dose

  6. The Probability of Requiring Rescue Medication

    Assessed using the number of participants that took rescue medication within 24 hours after administration of study therapy

    Measured: 24 hours post-dose

  7. Sustained Pain Freedom

    Assessed using the number of participants that did not experience any headache pain through the time period of interest

    Measured: From 2 to 24 hours

  8. Sustained Pain Relief

    Assessed using the number of participants that did not experience any moderate or severe headache pain through the time period of interest.

    Measured: From 2 to 24 hours

  9. Sustained Pain Freedom

    Assessed using the number of participants that did not experience any headache pain through the time period of interest.

    Measured: From 2 to 48 hours

  10. Sustained Pain Relief

    Assessed using the number of participants that did not experience any moderate or severe headache pain through the time period of interest.

    Measured: From 2 to 48 hours

  11. Proportion of Participants Who Experienced 1 or More Treatment-emergent Adverse Events (AEs)

    Measured: up to 7 days after administration of study therapy

  12. Proportion of Participants Who Experienced 1 or More Treatment-emergent Serious Adverse Events (SAEs)

    Serious adverse events were assessed in the Safety Analysis Set.

    Measured: Up to 7 days after administration of study therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2025
  2. Study start11 Mar 2025
  3. Primary completion4 Aug 2025
  4. Study completion4 Aug 2025

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06848075
Sponsor's protocol ID
K-304 P001
Status last verified
Sep 2026
First submitted
21 Feb 2025
Last updated
20 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elismetrep (K-304) 2 mg, Elismetrep (K-304) 5 mg and Elismetrep (K-304) 10 mg in people with Migraine, run by Kallyope Inc. at 66 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 35 inclusion and 40 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: finished, as of the sponsor's last update on 20 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 66 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Freedom (time frame: 2 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06848075.

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 20 Oct 2026.

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