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Episodic MigrainePhase 3MINT-ENCT07018700

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

A Phase 3 study testing Xeomin in people with Episodic Migraine, run by Merz Therapeutics GmbH at 110 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

In this clinical trial, participants with episodic 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
Episodic 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
997 participants
Where
110 sitesin 13 countries
Study dates
21 Aug 2025to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) 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 ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and
  • During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary.

Who cannot join

  • Diagnosis of chronic migraine;
  • 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

110 sites in 13 countries.

110 sites in 13 countries

United States47 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

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

    McLean, Virginia, 22101

  • 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

  • BNL Health Inc., Merz Investigational Site #0010489

    Torrance, California, 90505

  • 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

Other trials in United States

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

Other trials in Poland

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

Other trials in Spain

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

Other trials in Czechia

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

Other trials in Germany

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

Other trials in Italy

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

Other trials in Slovakia

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

Other trials in France

Austria2 sites

  • Medical University of Innsbruck, Merz Investigational Site #0430043

    Innsbruck, 6020

  • Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042

    Klagenfurt, 9020

Other trials in Austria

Canada2 sites

  • Genge Partners Inc., Merz Investigational Site #0010525

    Montreal, H4A 3T2

  • CaRe Clinic, Merz Investigational Site #0010504

    Red Deer, T4P 1K4

Other trials in Canada

Switzerland2 sites

  • Inselspital Bern, Merz Investigational Site #0410003

    Bern, 3010

  • Kopfwehzentrum Hirslanden, Merz Investigational Site #0410017

    Zollikon, 8702

Other trials in Switzerland

Denmark1 site

  • Rigshospitalet-Glostrup, Merz Investigational Site #0450006

    Glostrup Municipality, 2600

Other trials in Denmark

United Kingdom1 site

  • Royal Stoke University Hospital, Merz Investigational Site #0440048

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

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 Episodic Migraine

In this clinical trial, participants with episodic 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.
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 groups in NCT07018700
Study groupRoleWhat they receive
Xeomin Dose AExperimentalPlacebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)
Receives: Drug: Xeomin
Xeomin Dose BExperimentalPlacebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)
Receives: Drug: Xeomin
PlaceboPlacebo comparatorPlacebo-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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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 12 months

  7. 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

  8. 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.

  1. First posted12 Jun 2025
  2. Study start21 Aug 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
997 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07018700
Sponsor's protocol ID
M602011085
Other IDs
2024-515715-22-00
Acronym
MINT-E
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xeomin in people with Episodic Migraine, run by Merz Therapeutics GmbH at 110 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Poland, Spain, Czechia, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07018700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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