NCT07116499

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

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Study of K-645 in the Treatment of Multiple Migraine Attacks

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Kallyope Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Placebo	Single oral dose of matching placebo
DRUG	K-645 dose level 1	Single oral dose of K-645 dose level 1
DRUG	K-645 dose level 2	Single oral dose of K-645 dose level 2

Timeline

• Start date: 2025-08-12
• Primary completion: 2025-11-07
• Completion: 2025-11-07
• First posted: 2025-08-11
• Last updated: 2025-11-25

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study