NCT06848075

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine: A Range of Doses Will be Evaluated

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Kallyope Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep as compared to placebo in the treatment of moderate or severe migraine.

Conditions

• Acute Migraine

Interventions

Type	Name	Description
DRUG	Elismetrep (K-304) Dose Level 1	Administered orally
DRUG	Elismetrep (K-304) Dose level 2	Administered orally
DRUG	Elismetrep (K-304) Dose level 3	Administered orally
DRUG	Elismetrep (K-304) Dose level 4	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2025-03-05
• Primary completion: 2025-08-11
• Completion: 2025-08-11
• First posted: 2025-02-26
• Last updated: 2025-09-03

Locations

66 sites across 1 country: United States

Regulatory

• FDA-regulated drug study