A Study of K-645 in the Treatment of Multiple Migraine Attacks

NCT07116499 | Terminated Phase 2 FDA Drug

• 1 other identifier: K-645 P003
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with pain freedom

  2 hours post-dose

Secondary Outcomes (4)

• Percentage of participants with freedom from the most bothersome symptom

  2 hours post-dose

• Percentage of participants who report pain relief

  2 hours post-dose

• Percentage of participants who experienced 1 or more treatment-emergent adverse events (AEs)

  up to 7 days after the last dose of study medication

• Percentage of participants who experienced 1 or more treatment-emergent serious adverse events (SAEs)

  up to 7 days after the last dose of study medication

Study Arms (2)

Treatment Sequence 1

EXPERIMENTAL

Drug: Placebo; Drug: K-645 dose level 1; Drug: K-645 dose level 2

Treatment Sequence 2

EXPERIMENTAL

Drug: Placebo; Drug: K-645 dose level 1; Drug: K-645 dose level 2

Interventions

Placebo DRUG

Single oral dose of matching placebo

Treatment Sequence 1; Treatment Sequence 2

K-645 dose level 1 DRUG

Single oral dose of K-645 dose level 1

Treatment Sequence 1; Treatment Sequence 2

K-645 dose level 2 DRUG

Single oral dose of K-645 dose level 2

Treatment Sequence 1; Treatment Sequence 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kallyope Inc.: lead

Study Sites (18)

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

DelRicht Research - Atlanta

Atlanta, Georgia, 30329, United States

Location

Clinical Research Atlanta - Stockbridge

Stockbridge, Georgia, 30281, United States

Location

Chicago Headache Center and Research Institute

Chicago, Illinois, 60657, United States

Location

Collective Medical Research

Overland Park, Kansas, 66202, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

DelRicht Research - Prairieville

Prairieville, Louisiana, 70817, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

Peters Medical Research

High Point, North Carolina, 27260, United States

Location

OK Clinical Research, LLC

Edmond, Oklahoma, 73034, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

DM Clinical Research - Bellaire

Houston, Texas, 77081, United States

Location

APD Clinical Research

Splendora, Texas, 77372, United States

Location

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study where the Sponsor, site staff and participants will be blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled, 3-period crossover study. In each period, participants will treat a single migraine attack. Participants will receive a different treatment in each of the three periods: placebo, K-645 dose level 1, or K-645 dose level 2.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 11, 2025
• Study Start: August 12, 2025
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)