A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing 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
- Chronic Migraine
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merz Therapeutics GmbH
- Enrolment target
- 780
- Started
- 21 August 2025
- Main results due
- October 2027
- Study sites
- 111
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(111)
TrialSphere Corp, Merz Investigational Site #0010513
Chandler, Arizona, United States
Recruiting
Arizona Neuroscience Research, Merz Investigational Site #0010521
Phoenix, Arizona, United States
Recruiting
Baptist Health Medical Center, Merz Investigational Site #0010520
Little Rock, Arkansas, United States
Recruiting
Chemidox Clinical Trials Inc, Merz Investigational Site #0010488
Lancaster, California, United States
Recruiting
Clinical Research Institute, Merz Investigational Site #0010487
Los Angeles, California, United States
Recruiting
BNL Health, Merz Investigational Site #0010501
Los Angeles, California, United States
Recruiting
Clinical Trials Management Services, Merz Investigational Site #0010526
Thousand Oaks, California, United States
Recruiting
Hasbani Neurology, Merz Investigational Site #0010509
New Haven, Connecticut, United States
Recruiting
Yale Center for Clinical Investigations, Merz Investigational Site #0010527
New Haven, Connecticut, United States
Recruiting
New England Institute Neurology and Headache, Merz Investigational Site #0010441
Stamford, Connecticut, United States
Recruiting
Northwest Florida Clinical Research Group, Merz Investigational Site #0010286
Gulf Breeze, Florida, United States
Recruiting
Nexus Clinical Research Center, Merz Investigational Site #0010514
Homestead, Florida, United States
Recruiting
Jacksonville Center for Clinical Research, Merz Investigational Site #0010515
Jacksonville, Florida, United States
Recruiting
Clinical Research of Central Florida, Merz Investigational Site #0010532
Lakeland, Florida, United States
Recruiting
University of Miami Miller School of Medicine, Merz Investigational Site #0010493
Miami, Florida, United States
Recruiting
American Research Institute, Merz Investigational Site #0010492
Miami, Florida, United States
Recruiting
Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499
West Palm Beach, Florida, United States
Recruiting
Accel Research - NeuroStudies, Merz Investigational Site #0010523
Decatur, Georgia, United States
Recruiting
Hawaii Pacific Neuroscience, Merz Investigational Site #0010510
Honolulu, Hawaii, United States
Recruiting
Kansas Institute of Research,, Merz Investigational Site #0010495
Overland Park, Kansas, United States
Recruiting
Crescent City Headache and Neurology Center, Merz Investigational Site #0010517
Chalmette, Louisiana, United States
Recruiting
DelRicht Clinical Research, Merz Investigational Site #0010518
New Orleans, Louisiana, United States
Recruiting
Sinai Hospital of Baltimore, Merz Investigational Site #0010505
Baltimore, Maryland, United States
Recruiting
MedVadis Research, Merz Investigational Site #0010524
Waltham, Massachusetts, United States
Recruiting
Mass Institute of Clinical Research, Merz Investigational Site #0010506
Westborough, Massachusetts, United States
Recruiting
Vida Clinical Studies, Merz Investigational Site #0010498
Dearborn Heights, Michigan, United States
Recruiting
Quest Research Institute, Merz Investigational Site #0010484
Farmington Hills, Michigan, United States
Recruiting
Mayo Clinic, Merz Investigational Site #0010212
Rochester, Minnesota, United States
Recruiting
StudyMetrix Research, Merz Investigational Site #0010530
City of Saint Peters, Missouri, United States
Recruiting
Quality Clinical Research, Merz Investigational Site #0010522
Omaha, Nebraska, United States
Recruiting
Dent Neurosciences Research Center, Merz Investigational Site #0010486
Amherst, New York, United States
Recruiting
Integrative Clinical Trials, Merz Investigational Site #0010496
Brooklyn, New York, United States
Recruiting
New York Neurology Associates, Merz Investigational Site #0010500
New York, New York, United States
Recruiting
True North Neurology, Merz Investigational Site #0010508
Port Jefferson Station, New York, United States
Recruiting
Rochester Clinical Research, Merz Investigational Site #0010512
Rochester, New York, United States
Recruiting
Upstate Clinical Research Associates, Merz Investigational Site #0010485
Williamsville, New York, United States
Recruiting
Dayton Center for Neurological Disorders, Merz Investigational Site #0010531
Centerville, Ohio, United States
Recruiting
Headache Center of Hope, Merz Investigational Site #0010528
Cincinnati, Ohio, United States
Recruiting
University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491
Cleveland, Ohio, United States
Recruiting
Tekton Research, Merz Investigational Site #0010494
Edmond, Oklahoma, United States
Recruiting
Thomas Jefferson University, Merz Investigational Site #0010354
Philadelphia, Pennsylvania, United States
Recruiting
Coastal Neurology, Merz Investigational Site #0010503
Port Royal, South Carolina, United States
Recruiting
Alina Clinical Trials, Merz Investigational Site #0010511
Dallas, Texas, United States
Recruiting
Lone Star Neurology, Merz Investigational Site #0010497
Frisco, Texas, United States
Recruiting
MedStar Health - Department of Neurology, Merz Investigational Site #0010231
McLean, Virginia, United States
Recruiting
Gershon Pain Specialists, Merz Investigational Site #0010519
Virginia Beach, Virginia, United States
Recruiting
EvergreenHealth Research Department, Merz Investigational Site #0010516
Kirkland, Washington, United States
Recruiting
Gundersen Health System, Merz Investigational Site #0010507
La Crosse, Wisconsin, United States
Recruiting
Medical University of Innsbruck, Merz Investigational Site #0430043
Innsbruck, Austria
Recruiting
Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042
Klagenfurt, Austria
Recruiting
Genge Partners Inc., Merz Investigational Site #0010525
Montreal, Canada
Recruiting
CaRe Clinic, Merz Investigational Site #0010504
Red Deer, Canada
Recruiting
Pratia Brno, Merz Investigational Site #4200053
Brno, Czechia
Recruiting
Fakultní nemocnice Hradec Králové, Merz Investigational Site #4200056
Hradec Králové, Czechia
Recruiting
CLINTRIAL, Merz Investigational Site #4200052
Prague, Czechia
Recruiting
Axon Clinical, Merz Investigational Site #4200051
Prague, Czechia
Recruiting
Neuropsychiatrie, Merz Investigational Site #4200054
Prague, Czechia
Recruiting
Rigshospitalet-Glostrup, Merz Investigational Site #0450006
Glostrup Municipality, Denmark
Recruiting
CHU Clermont Ferrand, Merz Investigational Site #0330026
Clermont-Ferrand, France
Recruiting
Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069
La Tronche, France
Recruiting
Showing 60 of 111 sites — filter to narrow it down. 111 of the 111 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07018713. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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