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

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. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1).
2. 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 serumfollicle-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 participant's recall oftheir medical history OR c. Is a female of reproductive potential and: i. Agrees toremain abstinent from heterosexual activity OR ii. Agrees to use (or have theirpartner use) a birth control method that is acceptable from the first dose of studydrug until the End of Study visit.

Acceptable methods of birth control are:

1. Combined (estrogen and progestogen containing) hormonal contraception associatedwith 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 notthe primary mode of action;

8. Male or female condom with or without spermicide;

9. Cap, diaphragm or sponge with spermicide; a combination of male condom with eithercap, diaphragm or sponge with spermicide (double barrier methods).

10. 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:

Participants 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 duringthe planned course of the trial. 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 usuallyresolve spontaneously in less than 2 hours.

4. Has more than 15 headache-days per month or has taken medication for acute headacheon 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, orretinal migraine.

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

7. Is taking migraine prophylactic medication where the prescribed dose has changedduring the 3 months prior to screening (Visit 1) or anticipates any change duringthe study. Any withdrawal of preventive medications for the treatment of migraineshould 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 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. Is at imminent risk of self-harm, based on clinical interview and responses on theColumbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in theopinion 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 (includingSjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, orgenitourinary abnormalities or diseases or hepatic impairment that, per theinvestigator's judgement, may jeopardize the subject's safety or compliance with theprotocol, or otherwise interfere with interpretation of efficacy and/or safetyresults.

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. Has a history with current evidence of uncontrolled, unstable or recently diagnosedcardiovascular 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 ischemicattack 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 bypasssurgery or banding but not including cholecystectomy or appendectomy) or has adisease that causes malabsorption. Laboratory, vital sign, and electrocardiogram related

15. Has a positive test result at screening for hepatitis B surface antigen, hepatitis Cvirus antibody.

16. Has a screening estimated glomerular filtration rate estimated with the Modificationof 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 Screeningvisit. Note: An isolated bilirubin >1.5 X ULN is acceptable if bilirubin isfractionated 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/ordiastolic blood pressure >95 mmHg measured after at least 5 minutes at rest at theScreening Visit. Note: If a participant's blood pressure is exclusionary on thefirst triplicate assessment at the Screening Visit, they may have one repeattriplicate blood pressure assessment at that visit after another rest of at least 10minutes. 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:

23. If benzodiazepines are detected on the drug screen, this is not exclusionary ifthey are prescribed a benzodiazepine for a therapeutic purpose (e.g., forinsomnia) and confirmatory documentation is obtained from the prescribingphysician.

24. If amphetamines are detected on the drug screen, this is not exclusionary ifthe participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatorydocumentation is obtained from the prescribing physician, and the stimulantmedication in question is known to be detected as amphetamine on the drugscreen being used.

25. 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 (detailed in the protocol).

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

27. Has a history of use of ergotamine medications ≥10 days per month on a regular basisfor ≥3 months prior to screening.

28. 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 toprescription 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 knownhemoglobinopathy (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 or ever signed an informed consent forStudy K-304 P004. Note: Patients may not be screened at more than one trial site forthis study.

33. Has any other disorder, unwillingness or inability, not covered by any of the otherexclusion criteria, which in the investigator's opinion, might jeopardize theparticipant'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.