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NCT07018713PHASE3Recruiting

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

Merz Therapeutics GmbH

Start Date

8/21/2025

Completion Date

3/1/2028

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Xeomin

DRUG

Placebo

Interested in This Trial?

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Conditions

Chronic Migraine

Locations

TrialSphere Corp, Merz Investigational Site #0010513

Chandler, Arizona 85286

United States

Arizona Neuroscience Research, Merz Investigational Site #0010521

Phoenix, Arizona 85018

United States

Baptist Health Medical Center, Merz Investigational Site #0010520

Little Rock, Arkansas 72205

United States

Chemidox Clinical Trials Inc, Merz Investigational Site #0010488

Lancaster, California 93534

United States

Clinical Research Institute, Merz Investigational Site #0010487

Los Angeles, California 90048

United States

BNL Health, Merz Investigational Site #0010501

Los Angeles, California 90067

United States

Clinical Trials Management Services, Merz Investigational Site #0010526

Thousand Oaks, California 91360

United States

Hasbani Neurology, Merz Investigational Site #0010509

New Haven, Connecticut 06511

United States

Yale Center for Clinical Investigations, Merz Investigational Site #0010527

New Haven, Connecticut 06519

United States

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

Stamford, Connecticut 06905

United States

Northwest Florida Clinical Research Group, Merz Investigational Site #0010286

Gulf Breeze, Florida 32561

United States

Nexus Clinical Research Center, Merz Investigational Site #0010514

Homestead, Florida 33030

United States

Jacksonville Center for Clinical Research, Merz Investigational Site #0010515

Jacksonville, Florida 32216

United States

Clinical Research of Central Florida, Merz Investigational Site #0010532

Lakeland, Florida 33805

United States

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

Miami, Florida 33136

United States

American Research Institute, Merz Investigational Site #0010492

Miami, Florida 33157

United States

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

West Palm Beach, Florida 33407

United States

Accel Research - NeuroStudies, Merz Investigational Site #0010523

Decatur, Georgia 30030

United States

Hawaii Pacific Neuroscience, Merz Investigational Site #0010510

Honolulu, Hawaii 96817

United States

Kansas Institute of Research,, Merz Investigational Site #0010495

Overland Park, Kansas 66211

United States

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

Chalmette, Louisiana 70043

United States

DelRicht Clinical Research, Merz Investigational Site #0010518

New Orleans, Louisiana 70115

United States

Sinai Hospital of Baltimore, Merz Investigational Site #0010505

Baltimore, Maryland 21215

United States

MedVadis Research, Merz Investigational Site #0010524

Waltham, Massachusetts 02451

United States

Mass Institute of Clinical Research, Merz Investigational Site #0010506

Westborough, Massachusetts 01581

United States

Vida Clinical Studies, Merz Investigational Site #0010498

Dearborn Heights, Michigan 48127

United States

Quest Research Institute, Merz Investigational Site #0010484

Farmington Hills, Michigan 48334

United States

StudyMetrix Research, Merz Investigational Site #0010530

City of Saint Peters, Missouri 63303

United States

Quality Clinical Research, Merz Investigational Site #0010522

Omaha, Nebraska 68114

United States

Dent Neurosciences Research Center, Merz Investigational Site #0010486

Amherst, New York 14226

United States

Integrative Clinical Trials, Merz Investigational Site #0010496

Brooklyn, New York 11229

United States

New York Neurology Associates, Merz Investigational Site #0010500

New York, New York 10003

United States

True North Neurology, Merz Investigational Site #0010508

Port Jefferson Station, New York 11776

United States

Rochester Clinical Research, Merz Investigational Site #0010512

Rochester, New York 14609

United States

Upstate Clinical Research Associates, Merz Investigational Site #0010485

Williamsville, New York 14221

United States

Dayton Center for Neurological Disorders, Merz Investigational Site #0010531

Centerville, Ohio 45459

United States

Headache Center of Hope, Merz Investigational Site #0010528

Cincinnati, Ohio 45236

United States

University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491

Cleveland, Ohio 44106

United States

Tekton Research, Merz Investigational Site #0010494

Edmond, Oklahoma 73013

United States

Thomas Jefferson University, Merz Investigational Site #0010354

Philadelphia, Pennsylvania 19107

United States

Coastal Neurology, Merz Investigational Site #0010503

Port Royal, South Carolina 29935

United States

Alina Clinical Trials, Merz Investigational Site #0010511

Dallas, Texas 75209

United States

Lone Star Neurology, Merz Investigational Site #0010497

Frisco, Texas 75035

United States

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

McLean, Virginia 22101

United States

Gershon Pain Specialists, Merz Investigational Site #0010519

Virginia Beach, Virginia 23454

United States

EvergreenHealth Research Department, Merz Investigational Site #0010516

Kirkland, Washington 98034

United States

Gundersen Health System, Merz Investigational Site #0010507

La Crosse, Wisconsin 54601

United States

Medical University of Innsbruck, Merz Investigational Site #0430043

Innsbruck, 6020

Austria

Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042

Klagenfurt, 9020

Austria

Genge Partners Inc., Merz Investigational Site #0010525

Montreal, H4A 3T2

Canada

CaRe Clinic, Merz Investigational Site #0010504

Red Deer, T4P 1K4

Canada

Pratia Brno, Merz Investigational Site #4200053

Brno, 602 00

Czechia

Fakultní nemocnice Hradec Králové, Merz Investigational Site #4200056

Hradec Králové, 500 05

Czechia

CLINTRIAL, Merz Investigational Site #4200052

Prague, 100 00

Czechia

Axon Clinical, Merz Investigational Site #4200051

Prague, 150 00

Czechia

Neuropsychiatrie, Merz Investigational Site #4200054

Prague, 160 00

Czechia

Rigshospitalet-Glostrup, Merz Investigational Site #0450006

Glostrup Municipality, 2600

Denmark

CHU Clermont Ferrand, Merz Investigational Site #0330026

Clermont-Ferrand, 63000

France

Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069

La Tronche, 38700

France

CHU Nantes, Merz Investigational Site #0330068

Nantes, 44093

France

Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398

Berlin, 10117

Germany

Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394

Frankfurt, 65929

Germany

Universitätsmedizin Greifswald, Merz Investigational Site #0490397

Greifswald, 17475

Germany

Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396

Kassel, 34131

Germany

Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395

Kiel, 24149

Germany

Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023

Florence, 50134

Italy

Ospedale San Raffaele, Merz Investigational Site #0390027

Milan, 20132

Italy

Istituto Auxologico Italiano, Merz Investigational Site #0390024

Milan, 20149

Italy

Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #0390025

Pavia, 27100

Italy

IRCCS San Raffaele Roma, Merz Investigational Site #0390026

Roma, 00166

Italy

Centrum Medyczne Neuromed, Merz Investigational Site #0480117

Bydgoszcz, 85-163

Poland

AthleticoMed, Merz Investigational Site #0480127

Bydgoszcz, 85-752

Poland

ETG Debica, Merz Investigational Site #0480121

Dębica, 39-200

Poland

Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126

Gdynia, 81-338

Poland

Silmedic Sp. z o.o., Merz Investigational Site #0480115

Katowice, 40-282

Poland

Jan Banach Research Spot, Merz Investigational Site #0480059

Krakow, 30-539

Poland

Pratia MCM, Merz Investigational Site #0480087

Krakow, 30-727

Poland

FutureMeds, Merz Investigational Site #0480125

Krakow, 31-501

Poland

Krakowska Akademia Neurologii, Merz Investigational Site #0480031

Krakow, 31-505

Poland

Neurocor, Merz Investigational Site #0480119

Krakow, 31-870

Poland

Clinirem, Merz Investigational Site #0480128

Lublin, 20-064

Poland

ETG Lublin, Merz Investigational Site #0480118

Lublin, 20-412

Poland

Indywidualna Praktyka Lekarska Dr hab. Med. Anna Szczepańska-Szerej, Merz Investigational Site #0480096

Lublin, 20-582

Poland

Instytut Zdrowia dr Boczarska-Jedynak, Merz Investigational Site #0480103

Oświęcim, 32-600

Poland

Solumed Centrum Medyczne, Merz Investigational Site #0480122

Poznan, 60-529

Poland

ETG Neuroscience, Merz Investigational Site #0480116

Warsaw, 02-677

Poland

MIGRE Polskie Centrum Leczenia Migreny, Merz Investigational Site #0480124

Wroclaw, 52-210

Poland

Futuremeds, Merz Investigational Site #0480123

Wroclaw, 53-673

Poland

ETG Zamosc, Merz Investigational Site #0480120

Zamość, 22-400

Poland

MUDr. Beáta Dupejová, neurologická ambulancia, Merz Investigational Site #4210002

Banská Bystrica, 974 04

Slovakia

KONZÍLIUM, Merz Investigational Site #4210011

Dubnica nad Váhom, 018 41

Slovakia

NEURES, Merz Investigational Site #4210006

Krompachy, 053 42

Slovakia

Liptovská nemocnica s poliklinikou, Merz Investigational Site #4210013

Liptovský Mikuláš, 031 23

Slovakia

Hospital Clinic de Barcelona-Hospital Plato, Merz Investigational Site #0340047

Barcelona, 08006

Spain

Hospital Universitari Vall d'Hebron, Merz Investigational Site #0340006

Barcelona, 08035

Spain

Hospital Universitario 12 de Octubre, Merz Investigational Site #0340055

Madrid, 28041

Spain

Hospital Universitario La Paz, Merz Investigational Site #0340007

Madrid, 28046

Spain

Campus Blua Sanitas Valdebebas Hospital, Merz Investigational Site #0340057

Madrid, 28055

Spain

Hospital Regional Universitario de Malaga, Merz Investigational Site #0340050

Málaga, 29010

Spain

Hospital Universitario Virgen de la Victoria, Merz Investigational Site #0340056

Málaga, 29010

Spain

Hospital Vithas Malaga, Merz Investigational Site #0340054

Málaga, 29016

Spain

Hospital Universitario Virgen del Rocio, Merz Investigational Site #0340046

Seville, 41013

Spain

Consorci Sanitari de Terrassa, Merz Investigational Site #0340051

Terrassa, 08227

Spain

Hospital Universitari i Politecnic La Fe de Valencia, Merz Investigational Site #0340049

Valencia, 46026

Spain

Complejo Hospitalario Universitario de Vigo, Merz Investigational Site #0340052

Vigo, 36312

Spain

Hospital Viamed Montecanal, Merz Investigational Site #0340053

Zaragoza, 50012

Spain

Inselspital Bern, Merz Investigational Site #0410003

Bern, 3010

Switzerland

Kopfwehzentrum Hirslanden, Merz Investigational Site #0410017

Zollikon, 8702

Switzerland

Royal Stoke University Hospital, Merz Investigational Site #0440048

Stoke-on-Trent, ST4 6QG

United Kingdom