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

NCT07018713 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2026-05-08

No results posted yet for this study

Summary

In this clinical trial, participants with chronic 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

  • Chronic Migraine

Interventions

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)

Sponsors & Collaborators

  • Merz Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2027-10-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Poland
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018713 on ClinicalTrials.gov