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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

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.

ArizonaTrialSphere Corp, Merz Investigational Site #0010513, Chandler
Arizona Neuroscience Research, Merz Investigational Site #0010521, Phoenix
ArkansasBaptist Health Medical Center, Merz Investigational Site #0010520, Little Rock
CaliforniaChemidox 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
ConnecticutHasbani 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
FloridaNorthwest 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
GeorgiaAccel Research - NeuroStudies, Merz Investigational Site #0010523, Decatur
HawaiiHawaii Pacific Neuroscience, Merz Investigational Site #0010510, Honolulu
KansasKansas Institute of Research,, Merz Investigational Site #0010495, Overland Park
LouisianaCrescent City Headache and Neurology Center, Merz Investigational Site #0010517, Chalmette
DelRicht Clinical Research,, Merz Investigational Site #0010518, New Orleans
MarylandSinai Hospital of Baltimore, Merz Investigational Site #0010505, Baltimore
MassachusettsMedVadis Research, Merz Investigational Site #0010524, Waltham
Mass Institute of Clinical Research, Merz Investigational Site #0010506, Westborough
MichiganVida Clinical Studies, Merz Investigational Site #0010498, Dearborn Heights
Quest Research Institute, Merz Investigational Site #0010484, Farmington Hills
MinnesotaMayo Clinic, Merz Investigational Site #0010212, Rochester
MissouriStudyMetrix Research, Merz Investigational Site #0010530, City of Saint Peters
NebraskaQuality Clinical Research, Merz Investigational Site #0010522, Omaha
New YorkDent 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
OhioDayton 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
OklahomaTekton Research, Merz Investigational Site #0010494, Edmond
PennsylvaniaThomas Jefferson University, Merz Investigational Site #0010354, Philadelphia
South CarolinaCoastal Neurology, Merz Investigational Site #0010503, Port Royal
TexasAlina Clinical Trials, Merz Investigational Site #0010511, Dallas
Lone Star Neurology, Merz Investigational Site #0010497, Frisco
VirginiaMedStar Health - Department of Neurology, Merz Investigational Site #0010231, McLean
Gershon Pain Specialists, Merz Investigational Site #0010519, Virginia Beach
WashingtonEvergreenHealth Research Department, Merz Investigational Site #0010516, Kirkland
WisconsinGundersen 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.