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

NCT ID: NCT07018700
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Merz Therapeutics GmbH
Conditions: Episodic Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 990 participants (Estimated).

What is being studied

Intervention: Amino Acids, Peptides, and Proteins
Intervention: Bacterial Proteins
Intervention: Bacterial Toxins
Intervention: Biological Factors
Intervention: Botulinum Toxins
Intervention: Botulinum Toxins, Type A
Intervention: Endopeptidases
Intervention: Enzymes
Intervention: Enzymes and Coenzymes
Intervention: Hydrolases
Intervention: incobotulinumtoxinA
Intervention: Metalloendopeptidases
Intervention: Metalloproteases
Intervention: Peptide Hydrolases
Drug: Placebo
Intervention: Proteins
Intervention: Toxins, Biological
Drug: Xeomin

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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.

Study locations

110 study locations are listed.

Recruiting site status is explicitly provided for 110 locations; 110 are listed as Recruiting.

Countries: Austria, Canada, Czechia, Denmark, France, Germany, Italy, Poland, Slovakia, Spain, Switzerland, United Kingdom, United States

Arizona, United States: 2
Arkansas, United States: 1
California, United States: 4
Connecticut, United States: 3
Florida, United States: 6
Georgia, United States: 1
Hawaii, United States: 1
Kansas, United States: 1
Louisiana, United States: 2
Maryland, United States: 1
Massachusetts, United States: 2
Michigan, United States: 2
Minnesota, United States: 1
Missouri, United States: 1
Nebraska, United States: 1
New York, United States: 6
Ohio, United States: 3
Oklahoma, United States: 1
Pennsylvania, United States: 1
South Carolina, United States: 1
Texas, United States: 2
Virginia, United States: 2
Washington, United States: 1
Wisconsin, United States: 1

Sample of listed locations

Medical University of Innsbruck, Merz Investigational Site #0430043 — Innsbruck, 6020, Austria — Recruiting
Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042 — Klagenfurt, 9020, Austria — Recruiting
Genge Partners Inc., Merz Investigational Site #0010525 — Montreal, H4A 3T2, Canada — Recruiting
CaRe Clinic, Merz Investigational Site #0010504 — Red Deer, T4P 1K4, Canada — Recruiting
Pratia Brno, Merz Investigational Site #4200053 — Brno, 602 00, Czechia — Recruiting
Fakultní nemocnice Hradec Králové, Merz Investigational Site #4200056 — Hradec Králové, 500 05, Czechia — Recruiting
Axon Clinical, Merz Investigational Site #4200051 — Prague, 150 00, Czechia — Recruiting
CLINTRIAL, Merz Investigational Site #4200052 — Prague, 100 00, Czechia — Recruiting
Neuropsychiatrie, Merz Investigational Site #4200054 — Prague, 160 00, Czechia — Recruiting
Rigshospitalet-Glostrup, Merz Investigational Site #0450006 — Glostrup Municipality, 2600, Denmark — Recruiting
CHU Clermont Ferrand, Merz Investigational Site #0330026 — Clermont-Ferrand, 63000, France — Recruiting
Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069 — La Tronche, 38700, France — Recruiting
CHU Nantes, Merz Investigational Site #0330068 — Nantes, 44093, France — Recruiting
Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398 — Berlin, 10117, Germany — Recruiting
Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394 — Frankfurt, 65929, Germany — Recruiting
Universitätsmedizin Greifswald, Merz Investigational Site #0490397 — Greifswald, 17475, Germany — Recruiting
Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396 — Kassel, 34131, Germany — Recruiting
Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395 — Kiel, 24149, Germany — Recruiting
Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023 — Florence, 50134, Italy — Recruiting
Istituto Auxologico Italiano, Merz Investigational Site #0390024 — Milan, 20149, Italy — Recruiting
Ospedale San Raffaele, Merz Investigational Site #0390027 — Milan, 20132, Italy — Recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #0390025 — Pavia, 27100, Italy — Recruiting
IRCCS San Raffaele Roma, Merz Investigational Site #0390026 — Roma, 00166, Italy — Recruiting
AthleticoMed, Merz Investigational Site #0480127 — Bydgoszcz, 85-752, Poland — Recruiting
Centrum Medyczne Neuromed, Merz Investigational Site #0480117 — Bydgoszcz, 85-163, Poland — Recruiting

Study details

Start date: August 21, 2025
Primary completion date: March 1, 2027
Completion date: October 1, 2027
First posted: June 12, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07018700
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT07018700 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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