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

Not Applicable

Recruiting

• Conditions: Acute Migraine
• Interventions: Drug: Placebo; Drug: K-645 dose level 1; Drug: K-645 dose level 2

• Registration Number: NCT07116499
• Lead Sponsor: Kallyope Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-07
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Study First Posted: 2025-08-11
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-08-29
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1	Placebo	-
Treatment Sequence 1	K-645 dose level 1	-
Treatment Sequence 1	K-645 dose level 2	-
Treatment Sequence 2	Placebo	-
Treatment Sequence 2	K-645 dose level 1	-
Treatment Sequence 2	K-645 dose level 2	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants with pain freedom	2 hours post-dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

Dent Neurosciences Research Center; 🇺🇸 Amherst, New York, United States

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

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