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Xeomin injections to prevent chronic 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 Chronic Migraine

Phase 3 Interventional Merz Pharmaceuticals GmbH · NCT07018713

This trial will test whether Xeomin injections into head and neck muscles can reduce the number of monthly migraine days for people with chronic migraine.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment780 (estimated)
Ages18 Years and up
SexAll
SponsorMerz Pharmaceuticals GmbH Industry-sponsored
Locations108 sites (Chandler, Arizona and 107 other locations)
Trial IDNCT07018713 on ClinicalTrials.gov

What this trial studies

Adults with chronic migraine will be assigned to receive either Xeomin or placebo injections into specific muscles of the head and neck and followed for about 52 to 55 weeks. Participants receive four treatments roughly 12 weeks apart, with a mix of on-site and remote visits totaling about 14 visits and a headache diary to track migraine days. The primary outcome is change in monthly migraine days compared with placebo, and safety will be monitored throughout the study. This is a phase 3, placebo-controlled trial sponsored by Merz Therapeutics.

Who should consider this trial

Good fit: Ideal candidates are adults meeting ICHD-3 criteria for chronic migraine who have had ≥15 headache days and ≥8 migraine days per month for each of the three months before screening and who record ≥15 headache days and ≥8 migraine days during the 28-day screening diary, with migraine onset before age 50.

Not a fit: Patients with other primary headache disorders (except tension-type headache), certain rare migraine subtypes (such as hemiplegic or retinal migraine), or those who do not meet the required headache frequency are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, Xeomin could reduce monthly migraine days and lower migraine-related disability for people with chronic migraine.

How similar studies have performed: Other botulinum toxin treatments (for example onabotulinumtoxinA/Botox) have shown benefit in chronic migraine, but Xeomin (incobotulinumtoxinA) is being tested specifically in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant has a diagnosis of CM with or without aura according to the International Classification of Headache Disorders Edition 3 criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches;
* Participant age \< 50 years at the time of migraine onset;
* Participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≥ 15 headache days per month and history of ≥ 8 migraine days per month; and
* During the last 28 days of the screening period, participant experiencing: ≥ 15 headache days and ≥ 8 migraine days that qualify as such per the headache diary.

Exclusion Criteria:

* Diagnosis of other primary headache types, except tension-type headache, which is permitted;
* Diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction;
* Diagnosis of secondary headache types, except medication overuse headache, which is permitted;
* Currently taking \> 1 prescribed drug for the preventive treatment of migraine;
* Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment less than 5 months prior to screening.

Where this trial is running

Chandler, Arizona and 107 other locations

+58 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.