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Clinical Trials in the UK / NCT07018713
Recruiting Phase 3

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713 · tracked via the Priya Life Science UK tracker
Sponsor
Merz Therapeutics GmbH
Phase
Phase 3
Started
2025-08-21
Last updated
2026-09-02

Condition(s) studied

Chronic Migraine

Investigational drug(s) / intervention(s)

XeominPlacebo

Xeomin: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

Placebo: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (111)

FacilityCityRegionStatus
TrialSphere Corp, Merz Investigational Site #0010513 Chandler Arizona Recruiting
Arizona Neuroscience Research, Merz Investigational Site #0010521 Phoenix Arizona Recruiting
Baptist Health Medical Center, Merz Investigational Site #0010520 Little Rock Arkansas Recruiting
Chemidox Clinical Trials Inc, Merz Investigational Site #0010488 Lancaster California Recruiting
Clinical Research Institute, Merz Investigational Site #0010487 Los Angeles California Recruiting
BNL Health, Merz Investigational Site #0010501 Los Angeles California Recruiting
Clinical Trials Management Services, Merz Investigational Site #0010526 Thousand Oaks California Recruiting
Hasbani Neurology, Merz Investigational Site #0010509 New Haven Connecticut Recruiting
Yale Center for Clinical Investigations, Merz Investigational Site #0010527 New Haven Connecticut Recruiting
New England Institute Neurology and Headache, Merz Investigational Site #0010441 Stamford Connecticut Recruiting
Northwest Florida Clinical Research Group, Merz Investigational Site #0010286 Gulf Breeze Florida Recruiting
Nexus Clinical Research Center, Merz Investigational Site #0010514 Homestead Florida Recruiting
Jacksonville Center for Clinical Research, Merz Investigational Site #0010515 Jacksonville Florida Recruiting
Clinical Research of Central Florida, Merz Investigational Site #0010532 Lakeland Florida Recruiting
University of Miami Miller School of Medicine, Merz Investigational Site #0010493 Miami Florida Recruiting
American Research Institute, Merz Investigational Site #0010492 Miami Florida Recruiting
Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499 West Palm Beach Florida Recruiting
Accel Research - NeuroStudies, Merz Investigational Site #0010523 Decatur Georgia Recruiting
Hawaii Pacific Neuroscience, Merz Investigational Site #0010510 Honolulu Hawaii Recruiting
Kansas Institute of Research,, Merz Investigational Site #0010495 Overland Park Kansas Recruiting
Crescent City Headache and Neurology Center, Merz Investigational Site #0010517 Chalmette Louisiana Recruiting
DelRicht Clinical Research, Merz Investigational Site #0010518 New Orleans Louisiana Recruiting
Sinai Hospital of Baltimore, Merz Investigational Site #0010505 Baltimore Maryland Recruiting
MedVadis Research, Merz Investigational Site #0010524 Waltham Massachusetts Recruiting
Mass Institute of Clinical Research, Merz Investigational Site #0010506 Westborough Massachusetts Recruiting
Vida Clinical Studies, Merz Investigational Site #0010498 Dearborn Heights Michigan Recruiting
Quest Research Institute, Merz Investigational Site #0010484 Farmington Hills Michigan Recruiting
Mayo Clinic, Merz Investigational Site #0010212 Rochester Minnesota Recruiting
StudyMetrix Research, Merz Investigational Site #0010530 City of Saint Peters Missouri Recruiting
Quality Clinical Research, Merz Investigational Site #0010522 Omaha Nebraska Recruiting
Dent Neurosciences Research Center, Merz Investigational Site #0010486 Amherst New York Recruiting
Integrative Clinical Trials, Merz Investigational Site #0010496 Brooklyn New York Recruiting
New York Neurology Associates, Merz Investigational Site #0010500 New York New York Recruiting
True North Neurology, Merz Investigational Site #0010508 Port Jefferson Station New York Recruiting
Rochester Clinical Research, Merz Investigational Site #0010512 Rochester New York Recruiting
Upstate Clinical Research Associates, Merz Investigational Site #0010485 Williamsville New York Recruiting
Dayton Center for Neurological Disorders, Merz Investigational Site #0010531 Centerville Ohio Recruiting
Headache Center of Hope, Merz Investigational Site #0010528 Cincinnati Ohio Recruiting
University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491 Cleveland Ohio Recruiting
Tekton Research, Merz Investigational Site #0010494 Edmond Oklahoma Recruiting

+ 71 more sites — see the full list on the official registry below.

More Merz Therapeutics GmbH trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07018713 on ClinicalTrials.gov ↗ ← All trials in the UK