NCT07018700

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial With Extension Period to Evaluate the Efficacy and Safety of Xeomin® Injections for the Prevention of Episodic Migraine

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 990 (estimated)
• Sponsor: Merz Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this clinical trial, participants with episodic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: * Trial duration: 52 to 55 weeks; * Screening period: 4 to 5 weeks; * Treatment duration: 4 treatments, each about 12 weeks apart; and * Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
DRUG	Xeomin	Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
DRUG	Placebo	Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

Timeline

• Start date: 2025-08-21
• Primary completion: 2027-03-01
• Completion: 2027-10-01
• First posted: 2025-06-12
• Last updated: 2026-04-08

Locations

104 sites across 13 countries: United States, Austria, Canada, Czechia, Denmark, France, Germany, Italy, Poland, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study