A Study of K-645 in the Treatment of Multiple Migraine Attacks (NCT07116499) | Clinical Trial Compass
TerminatedPhase 2
A Study of K-645 in the Treatment of Multiple Migraine Attacks
Stopped: Study stopped for futility based on an interim analysis of efficacy.
United States134 participantsStarted 2025-08-12
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled, 3-period crossover study to evaluate the safety, tolerability, and efficacy of two dose levels of K-645 in the treatment of patients with acute migraine.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be a male or female, age 18 to 65 years, inclusive, at the time of signing informed consent.
✓. Patient has greater than a one-year history of migraine with or without aura as defined by International Headache Society (IHS) criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated (refer to International Classification of Headache Disorders \[ICHD\] III Attachment for IHS migraine definitions) as documented in the patient's medical records from his/her treating physician and confirmed by the investigator.
✓. Patient has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the two months prior to Screening (Visit 1).
✓. Meet the following requirements:
✓. Is a male who agrees to all of the following:
✓. Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
✓. Voluntarily agrees to participate in the study by giving written informed consent.
✓. Is able to read, understand, and complete the study questionnaires and diary.
Exclusion criteria
✕. Is a female who is pregnant, breast-feeding or intends to become pregnant during the planned course of the study. Note: Female participants of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.
. Has difficulty distinguishing his/her migraine attacks from tension-type headaches.
✕. Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than two hours.
✕. 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 three months prior to Screening (Visit 1).
✕. Has brainstem (also known as \[a.k.a.\] basilar-type) or hemiplegic migraine headache, or retinal migraine.
✕. Was \>50 years old at age of first migraine onset.
✕. Is taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to Screening (Visit 1) or anticipates any change during the study.
✕. Stopped preventive migraine medication(s) within 30 days prior to Screening for small molecules or 90 days for antibodies.