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A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
Sponsor: Merz Therapeutics GmbH
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.
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 Chronic Migraine
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
780
Start Date
2025-08-21
Completion Date
2028-03
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
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)
Locations (104)
TrialSphere Corp, Merz Investigational Site #0010513
Chandler, Arizona, United States
Arizona Neuroscience Research, Merz Investigational Site #0010521
Phoenix, Arizona, United States
Baptist Health Medical Center, Merz Investigational Site #0010520
Little Rock, Arkansas, United States
Chemidox Clinical Trials Inc, Merz Investigational Site #0010488
Lancaster, California, United States
Clinical Research Institute, Merz Investigational Site #0010487
Los Angeles, California, United States
BNL Health, Merz Investigational Site #0010501
Los Angeles, California, United States
Clinical Trials Management Services, Merz Investigational Site #0010526
Thousand Oaks, California, United States
Hasbani Neurology, Merz Investigational Site #0010509
New Haven, Connecticut, United States
Yale Center for Clinical Investigations, Merz Investigational Site #0010527
New Haven, Connecticut, United States
New England Institute Neurology and Headache, Merz Investigational Site #0010441
Stamford, Connecticut, United States
Northwest Florida Clinical Research Group, Merz Investigational Site #0010286
Gulf Breeze, Florida, United States
Nexus Clinical Research Center, Merz Investigational Site #0010514
Homestead, Florida, United States
Jacksonville Center for Clinical Research, Merz Investigational Site #0010515
Jacksonville, Florida, United States
Clinical Research of Central Florida, Merz Investigational Site #0010532
Lakeland, Florida, United States
American Research Institute, Merz Investigational Site #0010492
Miami, Florida, United States
Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499
West Palm Beach, Florida, United States
Accel Research - NeuroStudies, Merz Investigational Site #0010523
Decatur, Georgia, United States
Hawaii Pacific Neuroscience, Merz Investigational Site #0010510
Honolulu, Hawaii, United States
Kansas Institute of Research,, Merz Investigational Site #0010495
Overland Park, Kansas, United States
Crescent City Headache and Neurology Center, Merz Investigational Site #0010517
Chalmette, Louisiana, United States
DelRicht Clinical Research, Merz Investigational Site #0010518
New Orleans, Louisiana, United States
Sinai Hospital of Baltimore, Merz Investigational Site #0010505
Baltimore, Maryland, United States
MedVadis Research, Merz Investigational Site #0010524
Waltham, Massachusetts, United States
Mass Institute of Clinical Research, Merz Investigational Site #0010506
Westborough, Massachusetts, United States
Vida Clinical Studies, Merz Investigational Site #0010498
Dearborn Heights, Michigan, United States
Quest Research Institute, Merz Investigational Site #0010484
Farmington Hills, Michigan, United States
StudyMetrix Research, Merz Investigational Site #0010530
City of Saint Peters, Missouri, United States
Quality Clinical Research, Merz Investigational Site #0010522
Omaha, Nebraska, United States
Dent Neurosciences Research Center, Merz Investigational Site #0010486
Amherst, New York, United States
Integrative Clinical Trials, Merz Investigational Site #0010496
Brooklyn, New York, United States
New York Neurology Associates, Merz Investigational Site #0010500
New York, New York, United States
True North Neurology, Merz Investigational Site #0010508
Port Jefferson Station, New York, United States
Rochester Clinical Research, Merz Investigational Site #0010512
Rochester, New York, United States
Upstate Clinical Research Associates, Merz Investigational Site #0010485
Williamsville, New York, United States
Dayton Center for Neurological Disorders, Merz Investigational Site #0010531
Centerville, Ohio, United States
Headache Center of Hope, Merz Investigational Site #0010528
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491
Cleveland, Ohio, United States
Tekton Research, Merz Investigational Site #0010494
Edmond, Oklahoma, United States
Coastal Neurology, Merz Investigational Site #0010503
Port Royal, South Carolina, United States
Alina Clinical Trials, Merz Investigational Site #0010511
Dallas, Texas, United States
Lone Star Neurology, Merz Investigational Site #0010497
Frisco, Texas, United States
MedStar Health - Department of Neurology, Merz Investigational Site #0010231
McLean, Virginia, United States
Gershon Pain Specialists, Merz Investigational Site #0010519
Virginia Beach, Virginia, United States
Gundersen Health System, Merz Investigational Site #0010507
La Crosse, Wisconsin, United States
Medical University of Innsbruck, Merz Investigational Site #0430043
Innsbruck, Austria
Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042
Klagenfurt, Austria
Genge Partners Inc., Merz Investigational Site #0010525
Montreal, Canada
CaRe Clinic, Merz Investigational Site #0010504
Red Deer, Canada
Pratia Brno, Merz Investigational Site #4200053
Brno, Czechia
CLINTRIAL, Merz Investigational Site #4200052
Prague, Czechia
Axon Clinical, Merz Investigational Site #4200051
Prague, Czechia
Neuropsychiatrie, Merz Investigational Site #4200054
Prague, Czechia
Rigshospitalet-Glostrup, Merz Investigational Site #0450006
Glostrup Municipality, Denmark
CHU Clermont Ferrand, Merz Investigational Site #0330026
Clermont-Ferrand, France
Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069
La Tronche, France
CHU Nantes, Merz Investigational Site #0330068
Nantes, France
Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398
Berlin, Germany
Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394
Frankfurt, Germany
Universitätsmedizin Greifswald, Merz Investigational Site #0490397
Greifswald, Germany
Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396
Kassel, Germany
Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395
Kiel, Germany
Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023
Florence, Italy
Ospedale San Raffaele, Merz Investigational Site #0390027
Milan, Italy
Istituto Auxologico Italiano, Merz Investigational Site #0390024
Milan, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #0390025
Pavia, Italy
IRCCS San Raffaele Roma, Merz Investigational Site #0390026
Roma, Italy
Centrum Medyczne Neuromed, Merz Investigational Site #0480117
Bydgoszcz, Poland
AthleticoMed, Merz Investigational Site #0480127
Bydgoszcz, Poland
ETG Debica, Merz Investigational Site #0480121
Dębica, Poland
Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126
Gdynia, Poland
Silmedic Sp. z o.o., Merz Investigational Site #0480115
Katowice, Poland
Jan Banach Research Spot, Merz Investigational Site #0480059
Krakow, Poland
Pratia MCM, Merz Investigational Site #0480087
Krakow, Poland
FutureMeds, Merz Investigational Site #0480125
Krakow, Poland
Krakowska Akademia Neurologii, Merz Investigational Site #0480031
Krakow, Poland
Neurocor, Merz Investigational Site #0480119
Krakow, Poland
Clinirem, Merz Investigational Site #0480128
Lublin, Poland
ETG Lublin, Merz Investigational Site #0480118
Lublin, Poland
Indywidualna Praktyka Lekarska Dr hab. Med. Anna Szczepańska-Szerej, Merz Investigational Site #0480096
Lublin, Poland
Instytut Zdrowia dr Boczarska-Jedynak, Merz Investigational Site #0480103
Oświęcim, Poland
Solumed Centrum Medyczne, Merz Investigational Site #0480122
Poznan, Poland
ETG Neuroscience, Merz Investigational Site #0480116
Warsaw, Poland
MIGRE Polskie Centrum Leczenia Migreny, Merz Investigational Site #0480124
Wroclaw, Poland
Futuremeds, Merz Investigational Site #0480123
Wroclaw, Poland
ETG Zamosc, Merz Investigational Site #0480120
Zamość, Poland
MUDr. Beáta Dupejová, neurologická ambulancia, Merz Investigational Site #4210002
Banská Bystrica, Slovakia
KONZÍLIUM, Merz Investigational Site #4210011
Dubnica nad Váhom, Slovakia
NEURES, Merz Investigational Site #4210006
Krompachy, Slovakia
Liptovská nemocnica s poliklinikou, Merz Investigational Site #4210013
Liptovský Mikuláš, Slovakia
Hospital Clinic de Barcelona-Hospital Plato, Merz Investigational Site #0340047
Barcelona, Spain
Hospital Universitari Vall d'Hebron, Merz Investigational Site #0340006
Barcelona, Spain
Hospital Universitario 12 de Octubre, Merz Investigational Site #0340055
Madrid, Spain
Hospital Universitario La Paz, Merz Investigational Site #0340007
Madrid, Spain
Campus Blua Sanitas Valdebebas Hospital, Merz Investigational Site #0340057
Madrid, Spain
Hospital Regional Universitario de Malaga, Merz Investigational Site #0340050
Málaga, Spain
Hospital Universitario Virgen de la Victoria, Merz Investigational Site #0340056
Málaga, Spain
Hospital Vithas Malaga, Merz Investigational Site #0340054
Málaga, Spain
Hospital Universitario Virgen del Rocio, Merz Investigational Site #0340046
Seville, Spain
Consorci Sanitari de Terrassa, Merz Investigational Site #0340051
Terrassa, Spain
Hospital Universitari i Politecnic La Fe de Valencia, Merz Investigational Site #0340049
Valencia, Spain
Complejo Hospitalario Universitario de Vigo, Merz Investigational Site #0340052
Vigo, Spain
Hospital Viamed Montecanal, Merz Investigational Site #0340053
Zaragoza, Spain
Kopfwehzentrum Hirslanden, Merz Investigational Site #0410017
Zollikon, Switzerland
Royal Stoke University Hospital, Merz Investigational Site #0440048
Stoke-on-Trent, United Kingdom