A Study of K-645 in the Treatment of Multiple Migraine Attacks
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Acute Migraine
In brief
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.
Key facts
- Study ID
- NCT07116499
- Run by
- Kallyope Inc.
- People needed
- 134
- Starts
- 2025-08-12
- Expected to finish
- 2025-11-07
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- If partner is a non-pregnant female of childbearing potential: To use an appropriate method of contraception, including a condom with spermicidal cream or jelly, from the first dose of study drug until ≥72 hours after the last dose of study drug (i.e. Period 3). A male participant who has had a vasectomy procedure must use a condom but is not required to use spermicidal cream or jelly.
- If partner is pregnant: To use a condom from the first dose of study drug until ≥72 hours after the last dose of study drug.
- Note: Contraception/condom requirements are waived if partner is NOT of childbearing potential (i.e. is male or is a female who is post-menopausal or surgically sterile [post-hysterectomy or bilateral salpingectomy]).
- To not donate sperm from the first dose of study drug until ≥ 72 hours after the last dose of study drug.
- OR
- Is a female who is of non-childbearing potential defined by at least 1 of the following criteria:
- Postmenopausal defined as one of the following: a minimum of 12 months of spontaneous amenorrhea OR a minimum of 6 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone (FSH) level >40 mIU/mL OR at least 6 weeks post-bilateral oophorectomy (with or without hysterectomy).
- Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history.
- If pre-menopausal, they must agree to not donate eggs from the first dose of study drug until 30 days after the last dose study drug.
- OR c. Is a female of reproductive potential and:
- agrees to not donate eggs from the first dose of study drug until 30 days after the last dose study drug.
- AND
- agrees to remain abstinent from heterosexual activity*,** or
- agrees to use (or have their partner use) a birth control method that is highly effective**. Acceptable methods of birth control are:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
- Progestogen-only contraception (e.g. oral, injectable, implant) associated with inhibition of ovulation
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner * Abstinence can be used as the sole method of contraception if it is in line with the participant'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.
Where it is running
- Excell Research, Inc. — Oceanside, California, United States
- DelRicht Research - Atlanta — Atlanta, Georgia, United States
- Clinical Research Atlanta - Stockbridge — Stockbridge, Georgia, United States
- Chicago Headache Center and Research Institute — Chicago, Illinois, United States
- Collective Medical Research — Overland Park, Kansas, United States
- L-MARC Research Center — Louisville, Kentucky, United States
- DelRicht Research - Prairieville — Prairieville, Louisiana, United States
- Clinical Research Institute — Minneapolis, Minnesota, United States
- Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States
- Dent Neurosciences Research Center — Amherst, New York, United States
- SPRI Clinical Trials, LLC — Brooklyn, New York, United States
- Headache Wellness Center — Greensboro, North Carolina, United States
- Peters Medical Research — High Point, North Carolina, United States
- OK Clinical Research, LLC — Edmond, Oklahoma, United States
- Clinical Research Associates, Inc. — Nashville, Tennessee, United States
- DM Clinical Research - Bellaire — Houston, Texas, United States
- APD Clinical Research — Splendora, Texas, United States
- Health Research of Hampton Roads, Inc. — Newport News, Virginia, United States
Full record on ClinicalTrials.gov
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