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

7 september 2026 uppdaterad av: Kallyope Inc.

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

1500

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Michael Crutchlow Kallyope Clinical Director and Medical Monitor, MD
  • Telefonnummer: 267-242-5109
  • E-post: mike.crutchlow@kallyope.com

Studieorter

  • Förenta staterna
    • Arizona
      • Glendale, Arizona, Förenta staterna, 85304
      • Phoenix, Arizona, Förenta staterna, 85006
      • Phoenix, Arizona, Förenta staterna, 85012
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72211
        • Preferred Research Partners, Inc.
        • Kontakt:
    • California
      • Canoga Park, California, Förenta staterna, 91304
        • Alliance Research Institute, Canoga Park
        • Kontakt:
      • Chula Vista, California, Förenta staterna, 91911
      • Fountain Valley, California, Förenta staterna, 92708
        • Ark Clinical Research, Fountain Valley
        • Kontakt:
      • Fullerton, California, Förenta staterna, 92835
        • Neurology Center of North Orange County
        • Kontakt:
      • Glendale, California, Förenta staterna, 91206
      • Long Beach, California, Förenta staterna, 90806
      • Long Beach, California, Förenta staterna, 90807
        • Accellacare - Long Beach
        • Kontakt:
      • Lynwood, California, Förenta staterna, 90262
        • Alliance Research Institute, Lynwood
        • Kontakt:
      • Northridge, California, Förenta staterna, 91325
      • Pasadena, California, Förenta staterna, 91101
      • Redding, California, Förenta staterna, 96001
      • San Diego, California, Förenta staterna, 92108
      • San Diego, California, Förenta staterna, 92108
      • San Francisco, California, Förenta staterna, 94102
      • Santa Ana, California, Förenta staterna, 92703
      • Van Nuys, California, Förenta staterna, 91606
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80012
      • Denver, Colorado, Förenta staterna, 80246
    • Connecticut
      • Stamford, Connecticut, Förenta staterna, 06905-1206
        • Ki Health Partners, LLC
        • Kontakt:
    • Florida
      • Hallandale, Florida, Förenta staterna, 33009
      • Lakeland, Florida, Förenta staterna, 33805
      • Miami, Florida, Förenta staterna, 33155
      • Ocoee, Florida, Förenta staterna, 34761
      • Orlando, Florida, Förenta staterna, 32819
      • Tampa, Florida, Förenta staterna, 33613
        • Cenexel Tampa FL
        • Kontakt:
      • West Palm Beach, Florida, Förenta staterna, 33407
        • Premiere Research Institute at Palm Beach Neurology
        • Kontakt:
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30328
        • Clinical Integrative Research Center of Atlanta
        • Kontakt:
      • Norcross, Georgia, Förenta staterna, 30092
      • Savannah, Georgia, Förenta staterna, 31406
    • Idaho
      • Boise, Idaho, Förenta staterna, 83709
    • Illinois
      • Gurnee, Illinois, Förenta staterna, 60031
        • Clinical Investigation Specialists, Inc.
        • Kontakt:
      • Skokie, Illinois, Förenta staterna, 60077
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46254
      • Merrillville, Indiana, Förenta staterna, 46410
    • Iowa
      • Ames, Iowa, Förenta staterna, 50010
      • Sioux City, Iowa, Förenta staterna, 51106
    • Massachusetts
      • Fall River, Massachusetts, Förenta staterna, 02721
        • NECCR PrimaCare Research, LLC
        • Kontakt:
      • Foxborough, Massachusetts, Förenta staterna, 02035
        • Neurology Center of New England P.C.
        • Kontakt:
    • Montana
      • Missoula, Montana, Förenta staterna, 59808
    • Nebraska
      • Norfolk, Nebraska, Förenta staterna, 68701
      • Omaha, Nebraska, Förenta staterna, 68114
        • Quality Clinical Research, Inc.
        • Kontakt:
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89121
        • Oasis Clinical Research
        • Kontakt:
    • New Jersey
      • Toms River, New Jersey, Förenta staterna, 08755
        • Bio Behavioral Health
        • Kontakt:
          • Ashok Patel
          • Telefonnummer: 732-244-2299
          • E-post: ap@bbhnj.com
    • North Carolina
      • Cary, North Carolina, Förenta staterna, 27518
      • Morehead City, North Carolina, Förenta staterna, 28557
      • Raleigh, North Carolina, Förenta staterna, 27609
      • Wilmington, North Carolina, Förenta staterna, 28401
      • Winston-Salem, North Carolina, Förenta staterna, 27103
    • North Dakota
    • Ohio
      • Beachwood, Ohio, Förenta staterna, 44122
      • Blue Ash, Ohio, Förenta staterna, 45242
      • Cincinnati, Ohio, Förenta staterna, 45236
      • Columbus, Ohio, Förenta staterna, 43213
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02818
    • South Carolina
      • Anderson, South Carolina, Förenta staterna, 29621
      • Gaffney, South Carolina, Förenta staterna, 29340
    • Texas
      • Austin, Texas, Förenta staterna, 78705
        • Central Texas Clinical Research
        • Kontakt:
      • Beaumont, Texas, Förenta staterna, 77702
      • Dallas, Texas, Förenta staterna, 75230
      • DeSoto, Texas, Förenta staterna, 75115
      • El Paso, Texas, Förenta staterna, 79902
        • Newco 3A Researh LLC, DBA 3A Research
        • Kontakt:
      • Lake Jackson, Texas, Förenta staterna, 77566
      • San Antonio, Texas, Förenta staterna, 78240
      • San Antonio, Texas, Förenta staterna, 78229
        • Clinical Trials of Texas, LLC, A Flourish Research Site
        • Kontakt:
      • Sugar Land, Texas, Förenta staterna, 77479
      • Tomball, Texas, Förenta staterna, 77375
        • DM Clinical Research, Tomball
        • Kontakt:
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84107
        • Wasatch Clinical Research, LLC
        • Kontakt:
      • Salt Lake City, Utah, Förenta staterna, 84124
        • Highland Clinical Research
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.
  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:

    1. 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.
    2. 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.
  23. 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).
  24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.
  25. Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.

  26. Has a history of non-narcotic analgesic intake ≥15 days per month for ≥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. 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 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.
  33. 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.
  34. 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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Elismetrep 10 mg
Participants received a single dose of elismetrep 10 mg
Läkemedel: Elismetrep
Administered orally
Andra namn:
  • K-304
Experimentell: Elismetrep 20 mg
Participants received a single dose of elismetrep 20 mg
Läkemedel: Elismetrep
Administered orally
Andra namn:
  • K-304
Placebo-jämförare: Placebo
Participants received a single dose of placebo
Läkemedel: Placebo
Administreras oralt

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain freedom at 2 hours post-dose
Tidsram: 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).
Two hours post-dose
Freedom from most bothersome symptoms (MBS) at 2 hours post-dose
Tidsram: 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).
Two hours post-dose

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sustained pain relief from 2 to 48 hours post-dose
Tidsram: 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.
From 2 to 48 hours post-dose
Percentage of participants who experience one or more treatment-emergent adverse events (AEs)
Tidsram: Up to 8 days post-dose
Up to 8 days post-dose
Percentage of participants who experience one or more treatment-emergent serious adverse events (SAEs)
Tidsram: Up to 8 days post-dose
Up to 8 days post-dose
Pain relief at 2 hours post-dose
Tidsram: Two 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.
Two hours post-dose
Sustained pain freedom from 2 to 24 hours post-dose
Tidsram: 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.
From 2 to 24 hours post-dose
Sustained pain freedom from 2 to 48 hours post-dose
Tidsram: 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.
From 2 to 48 hours post-dose
Sustained pain relief from 2 to 24 hours post-dose
Tidsram: 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.
From 2 to 24 hours post-dose
Freedom from functional disability at 2 hours post-dose
Tidsram: Two 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).
Two hours post-dose
Proportion requiring rescue medication within 24 hours post-dose
Tidsram: Within 24 hours post-dose
Percentage of subjects that take rescue medication within 24 hours post-dose.
Within 24 hours post-dose
Freedom from photophobia at 2 hours post-dose
Tidsram: Two 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.
Two hours post-dose
Freedom from phonophobia at 2 hours post-dose
Tidsram: Two 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.
Two hours post-dose
Freedom from nausea at 2 hours post-dose
Tidsram: Two 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.
Two hours post-dose
Pain relapse from 2 to 48 hours post-dose
Tidsram: 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.
From 2 to 48 hours post-dose

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Kallyope Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2027

Avslutad studie (Beräknad)

1 december 2027

Studieregistreringsdatum

Först inskickad

7 september 2026

Först inskickad som uppfyllde QC-kriterierna

7 september 2026

Första postat (Faktisk)

11 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • K-304 P004

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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