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

7 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

1500

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Michael Crutchlow Kallyope Clinical Director and Medical Monitor, MD
  • Numéro de téléphone: 267-242-5109
  • E-mail: mike.crutchlow@kallyope.com

Lieux d'étude

  • États-Unis
    • Arizona
      • Glendale, Arizona, États-Unis, 85304
      • Phoenix, Arizona, États-Unis, 85006
      • Phoenix, Arizona, États-Unis, 85012
    • Arkansas
      • Little Rock, Arkansas, États-Unis, 72211
        • Preferred Research Partners, Inc.
        • Contact:
    • California
      • Canoga Park, California, États-Unis, 91304
        • Alliance Research Institute, Canoga Park
        • Contact:
      • Chula Vista, California, États-Unis, 91911
      • Fountain Valley, California, États-Unis, 92708
        • Ark Clinical Research, Fountain Valley
        • Contact:
      • Fullerton, California, États-Unis, 92835
        • Neurology Center of North Orange County
        • Contact:
      • Glendale, California, États-Unis, 91206
      • Long Beach, California, États-Unis, 90806
      • Long Beach, California, États-Unis, 90807
        • Accellacare - Long Beach
        • Contact:
      • Lynwood, California, États-Unis, 90262
        • Alliance Research Institute, Lynwood
        • Contact:
      • Northridge, California, États-Unis, 91325
      • Pasadena, California, États-Unis, 91101
      • Redding, California, États-Unis, 96001
      • San Diego, California, États-Unis, 92108
      • San Diego, California, États-Unis, 92108
      • San Francisco, California, États-Unis, 94102
        • Optimus Medical Group
        • Contact:
      • Santa Ana, California, États-Unis, 92703
      • Van Nuys, California, États-Unis, 91606
    • Colorado
      • Aurora, Colorado, États-Unis, 80012
        • Paradigm Clinical Research Centers, LLC; Aurora
        • Contact:
      • Denver, Colorado, États-Unis, 80246
    • Connecticut
      • Stamford, Connecticut, États-Unis, 06905-1206
        • Ki Health Partners, LLC
        • Contact:
          • Peter Mcallister
          • Numéro de téléphone: 203-914-1900
          • E-mail: peter@neinh.com
    • Florida
      • Hallandale, Florida, États-Unis, 33009
      • Lakeland, Florida, États-Unis, 33805
      • Miami, Florida, États-Unis, 33155
      • Ocoee, Florida, États-Unis, 34761
      • Orlando, Florida, États-Unis, 32819
      • Tampa, Florida, États-Unis, 33613
        • Cenexel Tampa FL
        • Contact:
      • West Palm Beach, Florida, États-Unis, 33407
        • Premiere Research Institute at Palm Beach Neurology
        • Contact:
    • Georgia
      • Atlanta, Georgia, États-Unis, 30328
        • Clinical Integrative Research Center of Atlanta
        • Contact:
      • Norcross, Georgia, États-Unis, 30092
      • Savannah, Georgia, États-Unis, 31406
    • Idaho
      • Boise, Idaho, États-Unis, 83709
    • Illinois
      • Gurnee, Illinois, États-Unis, 60031
        • Clinical Investigation Specialists, Inc.
        • Contact:
      • Skokie, Illinois, États-Unis, 60077
        • Evanston Premier Healthcare Research, LLC
        • Contact:
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46254
      • Merrillville, Indiana, États-Unis, 46410
    • Iowa
      • Ames, Iowa, États-Unis, 50010
      • Sioux City, Iowa, États-Unis, 51106
        • Velocity Clinical Research, Sioux City
        • Contact:
    • Massachusetts
      • Fall River, Massachusetts, États-Unis, 02721
        • NECCR PrimaCare Research, LLC
        • Contact:
      • Foxborough, Massachusetts, États-Unis, 02035
        • Neurology Center of New England P.C.
        • Contact:
    • Montana
      • Missoula, Montana, États-Unis, 59808
    • Nebraska
      • Norfolk, Nebraska, États-Unis, 68701
      • Omaha, Nebraska, États-Unis, 68114
        • Quality Clinical Research, Inc.
        • Contact:
    • Nevada
      • Las Vegas, Nevada, États-Unis, 89121
        • Oasis Clinical Research
        • Contact:
    • New Jersey
      • Toms River, New Jersey, États-Unis, 08755
        • Bio Behavioral Health
        • Contact:
          • Ashok Patel
          • Numéro de téléphone: 732-244-2299
          • E-mail: ap@bbhnj.com
    • North Carolina
      • Cary, North Carolina, États-Unis, 27518
      • Morehead City, North Carolina, États-Unis, 28557
      • Raleigh, North Carolina, États-Unis, 27609
      • Wilmington, North Carolina, États-Unis, 28401
      • Winston-Salem, North Carolina, États-Unis, 27103
    • North Dakota
      • Fargo, North Dakota, États-Unis, 58104
    • Ohio
      • Beachwood, Ohio, États-Unis, 44122
        • Velocity Clinical Research, Cleveland
        • Contact:
      • Blue Ash, Ohio, États-Unis, 45242
        • Velocity Clinical Research, Cincinnati, Blue Ash
        • Contact:
      • Cincinnati, Ohio, États-Unis, 45236
        • Headache Center of Hope
        • Contact:
      • Columbus, Ohio, États-Unis, 43213
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02818
        • Velocity Clinical Research, Providence
        • Contact:
    • South Carolina
      • Anderson, South Carolina, États-Unis, 29621
      • Gaffney, South Carolina, États-Unis, 29340
        • Velocity Clinical Research, Gaffney
        • Contact:
    • Texas
      • Austin, Texas, États-Unis, 78705
        • Central Texas Clinical Research
        • Contact:
      • Beaumont, Texas, États-Unis, 77702
        • Gadolin Research, LLC
        • Contact:
      • Dallas, Texas, États-Unis, 75230
      • DeSoto, Texas, États-Unis, 75115
      • El Paso, Texas, États-Unis, 79902
        • Newco 3A Researh LLC, DBA 3A Research
        • Contact:
      • Lake Jackson, Texas, États-Unis, 77566
      • San Antonio, Texas, États-Unis, 78240
      • San Antonio, Texas, États-Unis, 78229
        • Clinical Trials of Texas, LLC, A Flourish Research Site
        • Contact:
      • Sugar Land, Texas, États-Unis, 77479
      • Tomball, Texas, États-Unis, 77375
        • DM Clinical Research, Tomball
        • Contact:
    • Utah
      • Salt Lake City, Utah, États-Unis, 84107
        • Wasatch Clinical Research, LLC
        • Contact:
      • Salt Lake City, Utah, États-Unis, 84124
        • Highland Clinical Research
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Elismetrep 10 mg
Participants received a single dose of elismetrep 10 mg
Médicament: Elismetrep
Administered orally
Autres noms:
  • K-304
Expérimental: Elismetrep 20 mg
Participants received a single dose of elismetrep 20 mg
Médicament: Elismetrep
Administered orally
Autres noms:
  • K-304
Comparateur placebo: Placebo
Participants received a single dose of placebo
Médicament: Placebo
Administré par voie orale

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pain freedom at 2 hours post-dose
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sustained pain relief from 2 to 48 hours post-dose
Délai: 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)
Délai: 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)
Délai: Up to 8 days post-dose
Up to 8 days post-dose
Pain relief at 2 hours post-dose
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kallyope Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 septembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

7 septembre 2026

Première soumission répondant aux critères de contrôle qualité

7 septembre 2026

Première publication (Réel)

11 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • K-304 P004

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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