RecruitingMigraine

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

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About this study

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.

Sponsor: Kallyope Inc.

You may qualify if…

✓ 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).

You may not qualify if…

✕ 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.