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A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine
RecruitingPhase 3
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
Who can join
Ages 18 and older · All sexes
Full eligibility 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.
About the study
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 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.
What is being tested
- Xeomin (drug)
- Placebo (drug)
Sponsor: Merz Therapeutics GmbH · Participants: 990 · Started: Aug 21, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT07018700
Locations in the U.S.
| Arizona | TrialSphere Corp, Merz Investigational Site #0010513, Chandler Arizona Neuroscience Research, Merz Investigational Site #0010521, Phoenix |
| Arkansas | Baptist Health Medical Center, Merz Investigational Site #0010520, Little Rock |
| California | Chemidox Clinical Trials Inc, Merz Investigational Site #0010488, Lancaster Clinical Research Institute, Merz Investigational Site #0010487, Los Angeles Clinical Trials Management Services, Merz Investigational Site #0010526, Thousand Oaks BNL Health Inc., Merz Investigational Site #0010489, Torrance |
| Connecticut | Hasbani Neurology, Merz Investigational Site #0010509, New Haven Yale Center for Clinical Investigations, Merz Investigational Site #0010527, New Haven New England Institute Neurology and Headache, Merz Investigational Site #0010441, Stamford |
| Florida | Northwest Florida Clinical Research Group, Merz Investigational Site #0010286, Gulf Breeze Nexus Clinical Research Center, Merz Investigational Site #0010514, Homestead Jacksonville Center for Clinical Research, Merz Investigational Site #0010515, Jacksonville Clinical Research of Central Florida, Merz Investigational Site #0010532, Lakeland American Research Institute, Merz Investigational Site #0010492, Miami Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499, West Palm Beach |
| Georgia | Accel Research - NeuroStudies, Merz Investigational Site #0010523, Decatur |
| Hawaii | Hawaii Pacific Neuroscience, Merz Investigational Site #0010510, Honolulu |
| Kansas | Kansas Institute of Research,, Merz Investigational Site #0010495, Overland Park |
| Louisiana | Crescent City Headache and Neurology Center, Merz Investigational Site #0010517, Chalmette DelRicht Clinical Research,, Merz Investigational Site #0010518, New Orleans |
| Maryland | Sinai Hospital of Baltimore, Merz Investigational Site #0010505, Baltimore |
| Massachusetts | MedVadis Research, Merz Investigational Site #0010524, Waltham Mass Institute of Clinical Research, Merz Investigational Site #0010506, Westborough |
| Michigan | Vida Clinical Studies, Merz Investigational Site #0010498, Dearborn Heights Quest Research Institute, Merz Investigational Site #0010484, Farmington Hills |
| Minnesota | Mayo Clinic, Merz Investigational Site #0010212, Rochester |
| Missouri | StudyMetrix Research, Merz Investigational Site #0010530, City of Saint Peters |
| Nebraska | Quality Clinical Research, Merz Investigational Site #0010522, Omaha |
| New York | Dent Neurosciences Research Center, Merz Investigational Site #0010486, Amherst Integrative Clinical Trials, Merz Investigational Site #0010496, Brooklyn New York Neurology Associates, Merz Investigational Site #0010500, New York True North Neurology, Merz Investigational Site #0010508, Port Jefferson Station Rochester Clinical Research, Merz Investigational Site #0010512, Rochester Upstate Clinical Research Associates, Merz Investigational Site #0010485, Williamsville |
| Ohio | Dayton Center for Neurological Disorders, Merz Investigational Site #0010531, Centerville Headache Center of Hope, Merz Investigational Site #0010528, Cincinnati University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491, Cleveland |
| Oklahoma | Tekton Research, Merz Investigational Site #0010494, Edmond |
| Pennsylvania | Thomas Jefferson University, Merz Investigational Site #0010354, Philadelphia |
| South Carolina | Coastal Neurology, Merz Investigational Site #0010503, Port Royal |
| Texas | Alina Clinical Trials, Merz Investigational Site #0010511, Dallas Lone Star Neurology, Merz Investigational Site #0010497, Frisco |
| Virginia | MedStar Health - Department of Neurology, Merz Investigational Site #0010231, McLean Gershon Pain Specialists, Merz Investigational Site #0010519, Virginia Beach |
| Washington | EvergreenHealth Research Department, Merz Investigational Site #0010516, Kirkland |
| Wisconsin | Gundersen Health System, Merz Investigational Site #0010507, La Crosse |
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.