A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
NCT ID: NCT07018713
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
780 participants
INTERVENTIONAL
2025-08-21
2028-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Xeomin Dose A
Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)
Xeomin
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Xeomin Dose B
Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)
Xeomin
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Placebo
Placebo-controlled period: Placebo injections at pericranial and cervical points.
Extension period: Xeomin injections at pericranial and cervical points (dose A)
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Merz Therapeutics GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Therapeutics
Locations
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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
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
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
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
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
Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042
Klagenfurt, , Austria
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
Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023
Florence, , Italy
Istituto Auxologico Italiano, Merz Investigational Site #0390024
Milan, , Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #0390025
Pavia, , 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
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
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
KONZÍLIUM, Merz Investigational Site #4210011
Dubnica nad Váhom, , Slovakia
NEURES, Merz Investigational Site #4210006
Krompachy, , 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
Countries
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Central Contacts
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Other Identifiers
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2024-515682-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
M602011084
Identifier Type: -
Identifier Source: org_study_id
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