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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

Phase 3 Interventional Merz Pharmaceuticals GmbH · NCT07018700

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

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment990 (estimated)
Ages18 Years and up
SexAll
SponsorMerz Pharmaceuticals GmbH Industry-sponsored
Locations108 sites (Chandler, Arizona and 107 other locations)
Trial IDNCT07018700 on ClinicalTrials.gov

What this trial studies

In this randomized, placebo-controlled Phase 3 trial, adults with episodic migraine will receive Xeomin or placebo injections into specific head and neck muscles and be followed for about 52–55 weeks. Participants receive four treatments roughly 12 weeks apart, keep a headache diary, and have 14 scheduled visits including four on-site treatment visits and multiple remote visits. Eligible participants have a history of episodic migraine for at least 12 months and experience 6–14 migraine days per month, while patients with chronic migraine and several rare primary headache disorders are excluded. The primary outcome is the change in monthly migraine days comparing Xeomin to placebo.

Who should consider this trial

Good fit: Adults with episodic migraine for ≥12 months who have 6–14 migraine days per month and can distinguish migraine from other headaches are the ideal candidates.

Not a fit: Patients with chronic migraine or certain excluded primary headache disorders (for example aura-only syndromes or hemiplegic migraine) are not eligible and would not benefit from participating.

Why it matters

Potential benefit: If successful, Xeomin could reduce monthly migraine days and provide an additional preventive option for people with episodic migraine.

How similar studies have performed: Botulinum toxin injections (notably onabotulinumtoxinA) are effective for chronic migraine, but evidence for Xeomin specifically in episodic migraine is limited and less established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant has a diagnosis of EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) 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 ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and
* During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary.

Exclusion Criteria:

* Diagnosis of chronic migraine;
* 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 Episodic 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.