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Active, not recruiting Phase 3

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

NCT07018700 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-08-21
Last updated
2026-10-14

Condition(s) studied

Episodic Migraine

Investigational drug(s) / intervention(s)

Xeomin →Placebo

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 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.

Eligibility

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

Primary outcome measure(s)

  • Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A — Baseline to month 6

Trial sites (110)

FacilityCityRegionStatus
TrialSphere Corp, Merz Investigational Site #0010513 Chandler Arizona
Arizona Neuroscience Research, Merz Investigational Site #0010521 Phoenix Arizona
Baptist Health Medical Center, Merz Investigational Site #0010520 Little Rock Arkansas
Chemidox Clinical Trials Inc, Merz Investigational Site #0010488 Lancaster California
Clinical Research Institute, Merz Investigational Site #0010487 Los Angeles California
Clinical Trials Management Services, Merz Investigational Site #0010526 Thousand Oaks California
BNL Health Inc., Merz Investigational Site #0010489 Torrance California
Hasbani Neurology, Merz Investigational Site #0010509 New Haven Connecticut
Yale Center for Clinical Investigations, Merz Investigational Site #0010527 New Haven Connecticut
New England Institute Neurology and Headache, Merz Investigational Site #0010441 Stamford Connecticut
Northwest Florida Clinical Research Group, Merz Investigational Site #0010286 Gulf Breeze Florida
Nexus Clinical Research Center, Merz Investigational Site #0010514 Homestead Florida
Jacksonville Center for Clinical Research, Merz Investigational Site #0010515 Jacksonville Florida
Clinical Research of Central Florida, Merz Investigational Site #0010532 Lakeland Florida
American Research Institute, Merz Investigational Site #0010492 Miami Florida
Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499 West Palm Beach Florida
Accel Research - NeuroStudies, Merz Investigational Site #0010523 Decatur Georgia
Hawaii Pacific Neuroscience, Merz Investigational Site #0010510 Honolulu Hawaii
Kansas Institute of Research,, Merz Investigational Site #0010495 Overland Park Kansas
Crescent City Headache and Neurology Center, Merz Investigational Site #0010517 Chalmette Louisiana
DelRicht Clinical Research,, Merz Investigational Site #0010518 New Orleans Louisiana
Sinai Hospital of Baltimore, Merz Investigational Site #0010505 Baltimore Maryland
MedVadis Research, Merz Investigational Site #0010524 Waltham Massachusetts
Mass Institute of Clinical Research, Merz Investigational Site #0010506 Westborough Massachusetts
Vida Clinical Studies, Merz Investigational Site #0010498 Dearborn Heights Michigan
Quest Research Institute, Merz Investigational Site #0010484 Farmington Hills Michigan
Mayo Clinic, Merz Investigational Site #0010212 Rochester Minnesota
StudyMetrix Research, Merz Investigational Site #0010530 City of Saint Peters Missouri
Quality Clinical Research, Merz Investigational Site #0010522 Omaha Nebraska
Dent Neurosciences Research Center, Merz Investigational Site #0010486 Amherst New York
Integrative Clinical Trials, Merz Investigational Site #0010496 Brooklyn New York
New York Neurology Associates, Merz Investigational Site #0010500 New York New York
True North Neurology, Merz Investigational Site #0010508 Port Jefferson Station New York
Rochester Clinical Research, Merz Investigational Site #0010512 Rochester New York
Upstate Clinical Research Associates, Merz Investigational Site #0010485 Williamsville New York
Dayton Center for Neurological Disorders, Merz Investigational Site #0010531 Centerville Ohio
Headache Center of Hope, Merz Investigational Site #0010528 Cincinnati Ohio
University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491 Cleveland Ohio
Tekton Research, Merz Investigational Site #0010494 Edmond Oklahoma
Thomas Jefferson University, Merz Investigational Site #0010354 Philadelphia Pennsylvania

+ 70 more sites — see the full list on the official registry below.

More Merz Therapeutics GmbH trials in France

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 NCT07018700 on ClinicalTrials.gov ↗ ← All trials in France