Chronic MigrainePhase 3MINT-CNCT07018713
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
A Phase 3 study testing Xeomin in people with Chronic Migraine, run by Merz Therapeutics GmbH at 111 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Xeomin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 808 participants
- Where
- 111 sitesin 13 countries
- Study dates
- 21 Aug 2025to Sep 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
111 sites in 13 countries.
111 sites in 13 countries
United States48 sites
Dent Neurosciences Research Center, Merz Investigational Site #0010486
Amherst, New York, 14226
Sinai Hospital of Baltimore, Merz Investigational Site #0010505
Baltimore, Maryland, 21215
Integrative Clinical Trials, Merz Investigational Site #0010496
Brooklyn, New York, 11229
Dayton Center for Neurological Disorders, Merz Investigational Site #0010531
Centerville, Ohio, 45459
Crescent City Headache and Neurology Center, Merz Investigational Site #0010517
Chalmette, Louisiana, 70043
TrialSphere Corp, Merz Investigational Site #0010513
Chandler, Arizona, 85286
Headache Center of Hope, Merz Investigational Site #0010528
Cincinnati, Ohio, 45236
StudyMetrix Research, Merz Investigational Site #0010530
City of Saint Peters, Missouri, 63303
University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491
Cleveland, Ohio, 44106
Alina Clinical Trials, Merz Investigational Site #0010511
Dallas, Texas, 75209
Vida Clinical Studies, Merz Investigational Site #0010498
Dearborn Heights, Michigan, 48127
Accel Research - NeuroStudies, Merz Investigational Site #0010523
Decatur, Georgia, 30030
Tekton Research, Merz Investigational Site #0010494
Edmond, Oklahoma, 73013
Quest Research Institute, Merz Investigational Site #0010484
Farmington Hills, Michigan, 48334
Lone Star Neurology, Merz Investigational Site #0010497
Frisco, Texas, 75035
Northwest Florida Clinical Research Group, Merz Investigational Site #0010286
Gulf Breeze, Florida, 32561
Nexus Clinical Research Center, Merz Investigational Site #0010514
Homestead, Florida, 33030
Hawaii Pacific Neuroscience, Merz Investigational Site #0010510
Honolulu, Hawaii, 96817
Jacksonville Center for Clinical Research, Merz Investigational Site #0010515
Jacksonville, Florida, 32216
EvergreenHealth Research Department, Merz Investigational Site #0010516
Kirkland, Washington, 98034
Gundersen Health System, Merz Investigational Site #0010507
La Crosse, Wisconsin, 54601
Clinical Research of Central Florida, Merz Investigational Site #0010532
Lakeland, Florida, 33805
Chemidox Clinical Trials Inc, Merz Investigational Site #0010488
Lancaster, California, 93534
Baptist Health Medical Center, Merz Investigational Site #0010520
Little Rock, Arkansas, 72205
Clinical Research Institute, Merz Investigational Site #0010487
Los Angeles, California, 90048
BNL Health, Merz Investigational Site #0010501
Los Angeles, California, 90067
MedStar Health - Department of Neurology, Merz Investigational Site #0010231
McLean, Virginia, 22101
University of Miami Miller School of Medicine, Merz Investigational Site #0010493
Miami, Florida, 33136
American Research Institute, Merz Investigational Site #0010492
Miami, Florida, 33157
Hasbani Neurology, Merz Investigational Site #0010509
New Haven, Connecticut, 06511
Yale Center for Clinical Investigations, Merz Investigational Site #0010527
New Haven, Connecticut, 06519
DelRicht Clinical Research, Merz Investigational Site #0010518
New Orleans, Louisiana, 70115
New York Neurology Associates, Merz Investigational Site #0010500
New York, New York, 10003
Quality Clinical Research, Merz Investigational Site #0010522
Omaha, Nebraska, 68114
Kansas Institute of Research,, Merz Investigational Site #0010495
Overland Park, Kansas, 66211
Thomas Jefferson University, Merz Investigational Site #0010354
Philadelphia, Pennsylvania, 19107
Arizona Neuroscience Research, Merz Investigational Site #0010521
Phoenix, Arizona, 85018
True North Neurology, Merz Investigational Site #0010508
Port Jefferson Station, New York, 11776
Coastal Neurology, Merz Investigational Site #0010503
Port Royal, South Carolina, 29935
Mayo Clinic, Merz Investigational Site #0010212
Rochester, Minnesota, 59505
Rochester Clinical Research, Merz Investigational Site #0010512
Rochester, New York, 14609
New England Institute Neurology and Headache, Merz Investigational Site #0010441
Stamford, Connecticut, 06905
Clinical Trials Management Services, Merz Investigational Site #0010526
Thousand Oaks, California, 91360
Gershon Pain Specialists, Merz Investigational Site #0010519
Virginia Beach, Virginia, 23454
MedVadis Research, Merz Investigational Site #0010524
Waltham, Massachusetts, 02451
Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499
West Palm Beach, Florida, 33407
Mass Institute of Clinical Research, Merz Investigational Site #0010506
Westborough, Massachusetts, 01581
Upstate Clinical Research Associates, Merz Investigational Site #0010485
Williamsville, New York, 14221
Poland20 sites
Centrum Medyczne Neuromed, Merz Investigational Site #0480117
Bydgoszcz, 85-163
AthleticoMed, Merz Investigational Site #0480127
Bydgoszcz, 85-752
ETG Debica, Merz Investigational Site #0480121
Dębica, 39-200
Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126
Gdynia, 81-338
Silmedic Sp. z o.o., Merz Investigational Site #0480115
Katowice, 40-282
Jan Banach Research Spot, Merz Investigational Site #0480059
Krakow, 30-539
Pratia MCM, Merz Investigational Site #0480087
Krakow, 30-727
FutureMeds, Merz Investigational Site #0480125
Krakow, 31-501
Krakowska Akademia Neurologii, Merz Investigational Site #0480031
Krakow, 31-505
Neurocor, Merz Investigational Site #0480119
Krakow, 31-870
Clinirem, Merz Investigational Site #0480128
Lublin, 20-064
ETG Lublin, Merz Investigational Site #0480118
Lublin, 20-412
Indywidualna Praktyka Lekarska Dr hab. Med. Anna Szczepańska-Szerej, Merz Investigational Site #0480096
Lublin, 20-582
Instytut Zdrowia dr Boczarska-Jedynak, Merz Investigational Site #0480103
Oświęcim, 32-600
Solumed Centrum Medyczne, Merz Investigational Site #0480122
Poznan, 60-529
ETG Neuroscience, Merz Investigational Site #0480116
Warsaw, 02-677
MIGRE Polskie Centrum Leczenia Migreny, Merz Investigational Site #0480124
Wroclaw, 52-210
Futuremeds, Merz Investigational Site #0480123
Wroclaw, 53-673
ETG Zamosc, Merz Investigational Site #0480120
Zamość, 22-400
ProNeuro Centrum Medyczne Neurokard, Merz Investigational Site #0480129
Żory, 44-240
Spain13 sites
Hospital Clinic de Barcelona-Hospital Plato, Merz Investigational Site #0340047
Barcelona, 08006
Hospital Universitari Vall d'Hebron, Merz Investigational Site #0340006
Barcelona, 08035
Hospital Universitario 12 de Octubre, Merz Investigational Site #0340055
Madrid, 28041
Hospital Universitario La Paz, Merz Investigational Site #0340007
Madrid, 28046
Campus Blua Sanitas Valdebebas Hospital, Merz Investigational Site #0340057
Madrid, 28055
Hospital Regional Universitario de Malaga, Merz Investigational Site #0340050
Málaga, 29010
Hospital Universitario Virgen de la Victoria, Merz Investigational Site #0340056
Málaga, 29010
Hospital Vithas Malaga, Merz Investigational Site #0340054
Málaga, 29016
Hospital Universitario Virgen del Rocio, Merz Investigational Site #0340046
Seville, 41013
Consorci Sanitari de Terrassa, Merz Investigational Site #0340051
Terrassa, 08227
Hospital Universitari i Politecnic La Fe de Valencia, Merz Investigational Site #0340049
Valencia, 46026
Complejo Hospitalario Universitario de Vigo, Merz Investigational Site #0340052
Vigo, 36312
Hospital Viamed Montecanal, Merz Investigational Site #0340053
Zaragoza, 50012
Czechia5 sites
Pratia Brno, Merz Investigational Site #4200053
Brno, 602 00
Fakultní nemocnice Hradec Králové, Merz Investigational Site #4200056
Hradec Králové, 500 05
CLINTRIAL, Merz Investigational Site #4200052
Prague, 100 00
Axon Clinical, Merz Investigational Site #4200051
Prague, 150 00
Neuropsychiatrie, Merz Investigational Site #4200054
Prague, 160 00
Germany5 sites
Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398
Berlin, 10117
Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394
Frankfurt, 65929
Universitätsmedizin Greifswald, Merz Investigational Site #0490397
Greifswald, 17475
Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396
Kassel, 34131
Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395
Kiel, 24149
Italy5 sites
Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023
Florence, 50134
Ospedale San Raffaele, Merz Investigational Site #0390027
Milan, 20132
Istituto Auxologico Italiano, Merz Investigational Site #0390024
Milan, 20149
Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #0390025
Pavia, 27100
IRCCS San Raffaele Roma, Merz Investigational Site #0390026
Roma, 00166
Slovakia4 sites
MUDr. Beáta Dupejová, neurologická ambulancia, Merz Investigational Site #4210002
Banská Bystrica, 974 04
KONZÍLIUM, Merz Investigational Site #4210011
Dubnica nad Váhom, 018 41
NEURES, Merz Investigational Site #4210006
Krompachy, 053 42
Liptovská nemocnica s poliklinikou, Merz Investigational Site #4210013
Liptovský Mikuláš, 031 23
France3 sites
CHU Clermont Ferrand, Merz Investigational Site #0330026
Clermont-Ferrand, 63000
Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069
La Tronche, 38700
CHU Nantes, Merz Investigational Site #0330068
Nantes, 44093
Austria2 sites
Medical University of Innsbruck, Merz Investigational Site #0430043
Innsbruck, 6020
Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042
Klagenfurt, 9020
Canada2 sites
Genge Partners Inc., Merz Investigational Site #0010525
Montreal, H4A 3T2
CaRe Clinic, Merz Investigational Site #0010504
Red Deer, T4P 1K4
Switzerland2 sites
Inselspital Bern, Merz Investigational Site #0410003
Bern, 3010
Kopfwehzentrum Hirslanden, Merz Investigational Site #0410017
Zollikon, 8702
Denmark1 site
Rigshospitalet-Glostrup, Merz Investigational Site #0450006
Glostrup Municipality, 2600
United Kingdom1 site
Royal Stoke University Hospital, Merz Investigational Site #0440048
Stoke-on-Trent, ST4 6QG
About this study
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
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
- Being tested
- Xeomin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XeominDrug
Also called IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
PlaceboDrug
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
| Study group | Role | What they receive |
|---|---|---|
| Xeomin Dose A | Experimental | Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A) Receives: Drug: Xeomin |
| Xeomin Dose B | Experimental | Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B) Receives: Drug: Xeomin |
| Placebo | Placebo comparator | Placebo-controlled period: Placebo injections at pericranial and cervical points.
Extension period: Xeomin injections at pericranial and cervical points (dose A) Receives: Drug: Xeomin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
Measured: Baseline to month 6
Secondary outcomes (8)
Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B
Measured: Baseline to month 6
Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
Measured: Baseline to month 6
Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B
Measured: Baseline to month 6
Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
Measured: Baseline to month 6
Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B
Measured: Baseline to month 6
Change in frequency of migraine days from baseline (baseline monthly migraine days divided by 2) to two-week end-of-cycle periods (weeks 11 and 12 of Cycle 1 to 4)
Measured: Baseline up to month 11
Percentage of participants who reported at least a 50% reduction in mean monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection)
Measured: Baseline to month 6
Incidence of treatment-emergent adverse events (TEAEs) related to treatment as assessed by the investigator in the placebo-controlled period
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start21 Aug 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 808 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018713
- Sponsor's protocol ID
- M602011084
- Other IDs
- 2024-515682-34-00
- Acronym
- MINT-C
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No