Status:
RECRUITING
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine
Lead Sponsor:
Merz Therapeutics GmbH
Conditions:
Episodic Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
990 Patients enrolled
Trial Details
Trial ID
NCT07018700
Start Date
August 21 2025
End Date
October 1 2027
Last Update
March 2 2026
Active Locations (96)
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1
Arizona Neuroscience Research, Merz Investigational Site #0010521
Phoenix, Arizona, United States, 85018
2
Baptist Health Medical Center, Merz Investigational Site #0010520
Little Rock, Arkansas, United States, 72205
3
Chemidox Clinical Trials Inc, Merz Investigational Site #0010488
Lancaster, California, United States, 93534
4
Clinical Research Institute, Merz Investigational Site #0010487
Los Angeles, California, United States, 90048