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

Last updated: April 22, 2025
Sponsor: Kallyope Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Oral Facial Pain

Migraine (Adult)

Migraine And Cluster Headaches

Treatment

Placebo

Elismetrep (K-304) Dose level 4

Elismetrep (K-304) Dose Level 1

Clinical Study ID

NCT06848075
K-304 P001
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be a male or female, age 18 to 70 years, inclusive, at the time of signing informedconsent.

  2. Patient has greater than a one-year history of migraine with or without aura asdefined by International Conference on Harmonization (IHS) criteria 1.1 and 1.2 andhis/her migraines typically last between 4 to 72 hours, if untreated as documentedin the patient's medical records from his/her treating physician and confirmed bythe investigator.

  3. Patient has had ≥2 and ≤10 moderate or severe migraine attacks per month in each ofthe two months prior to screening (Visit 1).

  4. Meet the following requirements:

  5. Is a male OR

  6. Is a female who is of non-childbearing potential defined by at least 1 of thefollowing criteria:

  7. Postmenopausal (aged >45 years and with a minimum of 12 months of spontaneousamenorrhea with a Screening serum follicle-stimulating hormone (FSH) level inthe menopausal range established for the central laboratory.

  8. Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based onthe subject's recall of their medical history.OR

  9. Is a female of reproductive potential and:

  10. agrees to remain abstinent from heterosexual activity* *Abstinence can be used as the sole method of contraception if it is in linewith the subject's preferred and usual lifestyle and if considered acceptableby local regulatory agencies and ethics committees. Periodic abstinence (e.g.,calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) andwithdrawal are not acceptable methods of contraception.

  11. or agrees to use (or have their partner use) a birth control method that isacceptable 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 contraceptionassociated with inhibition of ovulation:
  • oral
  • intravaginal
  • transdermal
  • progestogen-only hormonal contraception associated with inhibition ofovulation:
  • 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 ofovulation 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 withspermicide (double barrier methods) This condition is waived if the subject is proven to have no child-bearing potential (eg, hysterectomy).
  1. Patient voluntarily agrees to participate in the study by giving written informedconsent.

  2. Patient is able to read, understand and complete the study questionnaires and diary.

  3. Be willing and able to comply with the study schedule of visits, all trialprocedures and restrictions.

  4. Be willing to use their own personal, qualified smartphone to download studyspecific eDiary applications for use during the study.

Exclusion

Exclusion Criteria:

  1. Is a female who is pregnant, breast-feeding or intends to become pregnant during theplanned course of the study. Note: Participants must have a negative serum pregnancytest (β-human chorionic gonadotropin (β-hCG)) performed by the central laboratoryprior to enrollment in the study and negative urine pregnancy result at therandomization visit. Migraine history-related

  2. Patient has difficulty distinguishing his/her migraine attacks from tension-typeheadaches.

  3. Patient has a history of predominantly mild migraine attacks or migraines thatusually resolve spontaneously in less than two hours.

  4. Patient has more than 15 headache-days per month or has taken medication for acuteheadache on more than 10 days per month in any of the three months prior toscreening (Visit 1).

  5. Patient has brainstem (a.k.a. basilar-type) or hemiplegic migraine headache, orretinal migraine.

  6. Patient was >50 years old at age of first migraine onset.

  7. Patient is taking migraine prophylactic medication where the prescribed daily dosehas changed during the 3 months prior to screening (Visit 1) or anticipates anychange during the study. Any withdrawal of preventive medications for the treatmentof migraine should be completed at least 30 days prior to screening. Medical history related

  8. Patient has, in the opinion of the investigator, other confounding pain syndromes,psychiatric conditions such as uncontrolled major depression, history of psychosis,dementia or significant neurological disorders other than migraine. [Patients whoare currently being treated with non-prohibited medication for depression andsymptoms are well controlled, in the opinion of the investigator, are eligible toparticipate in this study].

  9. Patient is at imminent risk of self-harm, based on clinical interview and responseson the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others inthe opinion of the investigator. Patients must be excluded if they report suicidalideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) inthe 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 currentdiagnosis or evidence of endocrine, hematological, immunological, renal,respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalitiesor diseases that, per the investigator's judgement, may jeopardize the subject'ssafety or compliance with the protocol, or otherwise interfere with interpretationof 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 theyhave received treatment and follow-up consistent with local standard of care.

  12. Patient history with current evidence of uncontrolled, unstable or recentlydiagnosed cardiovascular disease, such as ischemic heart disease, coronary arteryvasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), AcuteCoronary Syndrome (ACS), percutaneous Coronary Intervention (PCI), cardiac surgery,stroke or transient ischemic attack (TIA) during the 6 months prior to screening.

  13. Has a history of human immunodeficiency virus disease.

  14. Patient has a history of gastric or small intestinal surgery (including gastricbypass surgery or banding but not including cholecystectomy or appendectomy) or hasa disease that causes malabsorption. Laboratory, vital sign, and electrocardiogram (ECG) related

  15. Has a positive test result at Screening for hepatitis B surface antigen (Ag),hepatitis C virus antibody.

  16. Has a screening estimated Glomerular Filtration Rate (eGFR) estimated with theModification of Diet in Renal Disease (MDRD) equation of <45 ml/min/1.73 m2.

  17. Has a screening result for alanine aminotransferase or aspartate aminotransferase (ALT or AST) of >2.0X upper limit of normal (ULN) or total bilirubin >1.5X ULN atthe Screening visit. Note: An isolated bilirubin >1.5X ULN is acceptable ifbilirubin is fractionated, and direct bilirubin is within the laboratory normalrange.

  18. Has a corrected QT interval to Fridericia's formula (QTcF) >450 milliseconds (msec)for males and >470 msec for females at screening.

  19. Has a mean value for triplicate seated systolic blood pressure >160 mmHg and/ordiastolic blood pressure (BP) >95 mmHg measured after at least 5 minutes at rest atthe Screening Visit. Note: If a subject's BP is exclusionary on the first triplicate assessment at theScreening visit, they may have 1 repeat triplicate BP assessment at that visit afteranother 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 atScreening.

  21. Has use of soft drugs (such as marijuana or any substances containingtetrahydrocannabinol (THC) or cannabidiol (CBD)) within 3 months prior to Screening,or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior toScreening.

  22. Has a positive drug screen at Screening. Note: If benzodiazepines are detected onthe drug screen, this is not exclusionary if they are prescribed a benzodiazepinefor a therapeutic purpose (e.g. for insomnia) and confirmatory documentation isobtained from the prescribing physician.

  23. Is currently in violation of study requirements for prohibited and permissibleconcomitant medications (not already specified in other criteria) or is anticipatedto violate these requirements during study participation.

  24. Has any use of prescription opiate medications within 14 days of screening or anyanticipated/potential use of opiates during study participation.

  25. History of use of ergotamine medications on greater than/equal 10 days per month ona regular basis for greater than/equal 3 months prior to screening.

  26. History of non-narcotic analgesic intake on greater than/equal 15 days per month forgreater than/equal 3 months prior to screening. Other

  27. Has known or suspected hypersensitivity to trial product(s) or related products.

  28. Has a history of multiple significant and/or any severe allergies (e.g., food, drug,latex allergy) or has had an anaphylactic reaction or significant intolerance toprescription or nonprescription drugs or food.

  29. Has any surgery scheduled for the duration of the trial.

  30. Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4weeks prior to the Screening Visit; has a screening hemoglobin <11.0 g/dL (males) or <10.0 g/dL (females), or has a known hemoglobinopathy (e.g. sickle cell anemia,hemolytic anemia).

  31. Has previous participation in this trial. Participation is defined as signedinformed consent.

  32. Has participated in any clinical trial of an approved or non-approvedinvestigational biological medicinal product (e.g. antibody therapy) within 90 daysof Screening or has participated in any clinical trial of an approved ornon-approved investigational small molecule medicinal product within 30 days or 5half-lives (whichever is longer) of Screening.

  33. Has any other disorder, unwillingness or inability, not covered by any of the otherexclusion criteria, which in the investigator's opinion, might jeopardize thesubject's safety or compliance with the protocol, or otherwise interfere withinterpretation of efficacy and/or safety results.

  34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) ofthe Sponsor or study site.

Study Design

Total Participants: 400
Treatment Group(s): 5
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 05, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

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