Recruiting

Phase 3

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

Sponsor:

Merz Therapeutics GmbH

Code:

NCT07018713

Conditions

Chronic Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xeomin

Placebo

Study Details

Brief 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.

Conditions

Chronic Migraine

Study ID

NCT07018713

Start date

Aug 21, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

780 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Xeomin Dose A

Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)

experimental: Xeomin Dose B

Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)

placebo comparator: Placebo

Placebo-controlled period: Placebo injections at pericranial and cervical points.

Extension period: Xeomin injections at pericranial and cervical points (dose A)

Interventions

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)

Primary outcome measure

Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A [ Time Frame: Baseline to month 6 ]

Central Contacts and Locations

Central contacts

Public Disclosure Manager

+49691503 clinicaltrials@merz.com

Locations

TrialSphere Corp, Merz Investigational Site #0010513

Recruiting

Chandler, Arizona, United States, 85286

Arizona Neuroscience Research, Merz Investigational Site #0010521

Recruiting

Phoenix, Arizona, United States, 85018

Baptist Health Medical Center, Merz Investigational Site #0010520

Recruiting

Little Rock, Arkansas, United States, 72205

Chemidox Clinical Trials Inc, Merz Investigational Site #0010488

Recruiting

Lancaster, California, United States, 93534

Clinical Research Institute, Merz Investigational Site #0010487

Recruiting

Los Angeles, California, United States, 90048

BNL Health, Merz Investigational Site #0010501

Recruiting

Los Angeles, California, United States, 90067

Clinical Trials Management Services, Merz Investigational Site #0010526

Recruiting

Thousand Oaks, California, United States, 91360

Hasbani Neurology, Merz Investigational Site #0010509

Recruiting

New Haven, Connecticut, United States, 06511

Yale Center for Clinical Investigations, Merz Investigational Site #0010527

Recruiting

New Haven, Connecticut, United States, 06519

New England Institute Neurology and Headache, Merz Investigational Site #0010441

Recruiting

Stamford, Connecticut, United States, 06905

Northwest Florida Clinical Research Group, Merz Investigational Site #0010286

Recruiting

Gulf Breeze, Florida, United States, 32561

Nexus Clinical Research Center, Merz Investigational Site #0010514

Recruiting

Homestead, Florida, United States, 33030

Jacksonville Center for Clinical Research, Merz Investigational Site #0010515

Recruiting

Jacksonville, Florida, United States, 32216

Clinical Research of Central Florida, Merz Investigational Site #0010532

Recruiting

Lakeland, Florida, United States, 33805

University of Miami Miller School of Medicine, Merz Investigational Site #0010493

Recruiting

Miami, Florida, United States, 33136

American Research Institute, Merz Investigational Site #0010492

Recruiting

Miami, Florida, United States, 33157

Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499

Recruiting

West Palm Beach, Florida, United States, 33407

Accel Research - NeuroStudies, Merz Investigational Site #0010523

Recruiting

Decatur, Georgia, United States, 30030

Hawaii Pacific Neuroscience, Merz Investigational Site #0010510

Recruiting

Honolulu, Hawaii, United States, 96817

Kansas Institute of Research,, Merz Investigational Site #0010495

Recruiting

Overland Park, Kansas, United States, 66211

Crescent City Headache and Neurology Center, Merz Investigational Site #0010517

Recruiting

Chalmette, Louisiana, United States, 70043

DelRicht Clinical Research, Merz Investigational Site #0010518

Recruiting

New Orleans, Louisiana, United States, 70115

Sinai Hospital of Baltimore, Merz Investigational Site #0010505

Recruiting

Baltimore, Maryland, United States, 21215

MedVadis Research, Merz Investigational Site #0010524

Recruiting

Waltham, Massachusetts, United States, 02451

Mass Institute of Clinical Research, Merz Investigational Site #0010506

Recruiting

Westborough, Massachusetts, United States, 01581

Vida Clinical Studies, Merz Investigational Site #0010498

Recruiting

Dearborn Heights, Michigan, United States, 48127

Quest Research Institute, Merz Investigational Site #0010484

Recruiting

Farmington Hills, Michigan, United States, 48334

Mayo Clinic, Merz Investigational Site #0010212

Recruiting

Rochester, Minnesota, United States, 59505

StudyMetrix Research, Merz Investigational Site #0010530

Recruiting

City of Saint Peters, Missouri, United States, 63303

Quality Clinical Research, Merz Investigational Site #0010522

Recruiting

Omaha, Nebraska, United States, 68114

Dent Neurosciences Research Center, Merz Investigational Site #0010486

Recruiting

Amherst, New York, United States, 14226

Integrative Clinical Trials, Merz Investigational Site #0010496

Recruiting

Brooklyn, New York, United States, 11229

New York Neurology Associates, Merz Investigational Site #0010500

Recruiting

New York, New York, United States, 10003

True North Neurology, Merz Investigational Site #0010508

Recruiting

Port Jefferson Station, New York, United States, 11776

Rochester Clinical Research, Merz Investigational Site #0010512

Recruiting

Rochester, New York, United States, 14609

Upstate Clinical Research Associates, Merz Investigational Site #0010485

Recruiting

Williamsville, New York, United States, 14221

Dayton Center for Neurological Disorders, Merz Investigational Site #0010531

Recruiting

Centerville, Ohio, United States, 45459

Headache Center of Hope, Merz Investigational Site #0010528

Recruiting

Cincinnati, Ohio, United States, 45236

University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491

Recruiting

Cleveland, Ohio, United States, 44106

Tekton Research, Merz Investigational Site #0010494

Recruiting

Edmond, Oklahoma, United States, 73013

Thomas Jefferson University, Merz Investigational Site #0010354

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Coastal Neurology, Merz Investigational Site #0010503

Recruiting

Port Royal, South Carolina, United States, 29935

Alina Clinical Trials, Merz Investigational Site #0010511

Recruiting

Dallas, Texas, United States, 75209

Lone Star Neurology, Merz Investigational Site #0010497

Recruiting

Frisco, Texas, United States, 75035

MedStar Health - Department of Neurology, Merz Investigational Site #0010231

Recruiting

McLean, Virginia, United States, 22101

Gershon Pain Specialists, Merz Investigational Site #0010519

Recruiting

Virginia Beach, Virginia, United States, 23454

EvergreenHealth Research Department, Merz Investigational Site #0010516

Recruiting

Kirkland, Washington, United States, 98034

Gundersen Health System, Merz Investigational Site #0010507

Recruiting

La Crosse, Wisconsin, United States, 54601

Genge Partners Inc., Merz Investigational Site #0010525

Recruiting

Montreal, Canada, H4A 3T2

CaRe Clinic, Merz Investigational Site #0010504

Recruiting

Red Deer, Canada, T4P 1K4

More Information

Sponsor

Merz Therapeutics GmbH

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Merz Therapeutics GmbH on 2026-09-02.