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

NCT07018713 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: M6020110842024-515682-34-00
• Study Type: interventional
• Target: 780
• Locations: 13 countries
• Sites: 106

Brief 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.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (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

  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

  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

  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

  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

  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

  Baseline to month 6

Study Arms (3)

Xeomin Dose A

EXPERIMENTAL

Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)

Drug: Xeomin

Xeomin Dose B

EXPERIMENTAL

Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)

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)

Drug: Xeomin; Drug: Placebo

Interventions

Xeomin DRUG

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

Also known as: IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Placebo; Xeomin Dose A; Xeomin Dose B

Placebo DRUG

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Therapeutics GmbH: lead

Study Sites (106)

TrialSphere Corp, Merz Investigational Site #0010513

Chandler, Arizona, 85286, United States

RECRUITING

Arizona Neuroscience Research, Merz Investigational Site #0010521

Phoenix, Arizona, 85018, United States

RECRUITING

Baptist Health Medical Center, Merz Investigational Site #0010520

Little Rock, Arkansas, 72205, United States

RECRUITING

Chemidox Clinical Trials Inc, Merz Investigational Site #0010488

Lancaster, California, 93534, United States

RECRUITING

Clinical Research Institute, Merz Investigational Site #0010487

Los Angeles, California, 90048, United States

RECRUITING

BNL Health, Merz Investigational Site #0010501

Los Angeles, California, 90067, United States

RECRUITING

Clinical Trials Management Services, Merz Investigational Site #0010526

Thousand Oaks, California, 91360, United States

RECRUITING

Hasbani Neurology, Merz Investigational Site #0010509

New Haven, Connecticut, 06511, United States

RECRUITING

Yale Center for Clinical Investigations, Merz Investigational Site #0010527

New Haven, Connecticut, 06519, United States

RECRUITING

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

Stamford, Connecticut, 06905, United States

RECRUITING

Northwest Florida Clinical Research Group, Merz Investigational Site #0010286

Gulf Breeze, Florida, 32561, United States

RECRUITING

Nexus Clinical Research Center, Merz Investigational Site #0010514

Homestead, Florida, 33030, United States

RECRUITING

Jacksonville Center for Clinical Research, Merz Investigational Site #0010515

Jacksonville, Florida, 32216, United States

RECRUITING

Clinical Research of Central Florida, Merz Investigational Site #0010532

Lakeland, Florida, 33805, United States

RECRUITING

American Research Institute, Merz Investigational Site #0010492

Miami, Florida, 33157, United States

RECRUITING

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

West Palm Beach, Florida, 33407, United States

RECRUITING

Accel Research - NeuroStudies, Merz Investigational Site #0010523

Decatur, Georgia, 30030, United States

RECRUITING

Hawaii Pacific Neuroscience, Merz Investigational Site #0010510

Honolulu, Hawaii, 96817, United States

RECRUITING

Kansas Institute of Research,, Merz Investigational Site #0010495

Overland Park, Kansas, 66211, United States

RECRUITING

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

Chalmette, Louisiana, 70043, United States

RECRUITING

DelRicht Clinical Research, Merz Investigational Site #0010518

New Orleans, Louisiana, 70115, United States

RECRUITING

Sinai Hospital of Baltimore, Merz Investigational Site #0010505

Baltimore, Maryland, 21215, United States

RECRUITING

MedVadis Research, Merz Investigational Site #0010524

Waltham, Massachusetts, 02451, United States

RECRUITING

Mass Institute of Clinical Research, Merz Investigational Site #0010506

Westborough, Massachusetts, 01581, United States

RECRUITING

Vida Clinical Studies, Merz Investigational Site #0010498

Dearborn Heights, Michigan, 48127, United States

RECRUITING

Quest Research Institute, Merz Investigational Site #0010484

Farmington Hills, Michigan, 48334, United States

RECRUITING

StudyMetrix Research, Merz Investigational Site #0010530

City of Saint Peters, Missouri, 63303, United States

RECRUITING

Quality Clinical Research, Merz Investigational Site #0010522

Omaha, Nebraska, 68114, United States

RECRUITING

Dent Neurosciences Research Center, Merz Investigational Site #0010486

Amherst, New York, 14226, United States

RECRUITING

Integrative Clinical Trials, Merz Investigational Site #0010496

Brooklyn, New York, 11229, United States

RECRUITING

New York Neurology Associates, Merz Investigational Site #0010500

New York, New York, 10003, United States

RECRUITING

True North Neurology, Merz Investigational Site #0010508

Port Jefferson Station, New York, 11776, United States

RECRUITING

Rochester Clinical Research, Merz Investigational Site #0010512

Rochester, New York, 14609, United States

RECRUITING

Upstate Clinical Research Associates, Merz Investigational Site #0010485

Williamsville, New York, 14221, United States

RECRUITING

Dayton Center for Neurological Disorders, Merz Investigational Site #0010531

Centerville, Ohio, 45459, United States

RECRUITING

Headache Center of Hope, Merz Investigational Site #0010528

Cincinnati, Ohio, 45236, United States

RECRUITING

University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491

Cleveland, Ohio, 44106, United States

RECRUITING

Tekton Research, Merz Investigational Site #0010494

Edmond, Oklahoma, 73013, United States

RECRUITING

Coastal Neurology, Merz Investigational Site #0010503

Port Royal, South Carolina, 29935, United States

RECRUITING

Alina Clinical Trials, Merz Investigational Site #0010511

Dallas, Texas, 75209, United States

RECRUITING

Lone Star Neurology, Merz Investigational Site #0010497

Frisco, Texas, 75035, United States

RECRUITING

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

McLean, Virginia, 22101, United States

RECRUITING

Gershon Pain Specialists, Merz Investigational Site #0010519

Virginia Beach, Virginia, 23454, United States

RECRUITING

EvergreenHealth Research Department, Merz Investigational Site #0010516

Kirkland, Washington, 98034, United States

RECRUITING

Gundersen Health System, Merz Investigational Site #0010507

La Crosse, Wisconsin, 54601, United States

RECRUITING

Medical University of Innsbruck, Merz Investigational Site #0430043

Innsbruck, 6020, Austria

RECRUITING

Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042

Klagenfurt, 9020, Austria

RECRUITING

Genge Partners Inc., Merz Investigational Site #0010525

Montreal, H4A 3T2, Canada

RECRUITING

CaRe Clinic, Merz Investigational Site #0010504

Red Deer, T4P 1K4, Canada

RECRUITING

Pratia Brno, Merz Investigational Site #4200053

Brno, 602 00, Czechia

RECRUITING

Fakultní nemocnice Hradec Králové, Merz Investigational Site #4200056

Hradec Králové, 500 05, Czechia

RECRUITING

CLINTRIAL, Merz Investigational Site #4200052

Prague, 100 00, Czechia

RECRUITING

Axon Clinical, Merz Investigational Site #4200051

Prague, 150 00, Czechia

RECRUITING

Neuropsychiatrie, Merz Investigational Site #4200054

Prague, 160 00, Czechia

RECRUITING

Rigshospitalet-Glostrup, Merz Investigational Site #0450006

Glostrup Municipality, 2600, Denmark

RECRUITING

CHU Clermont Ferrand, Merz Investigational Site #0330026

Clermont-Ferrand, 63000, France

RECRUITING

Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069

La Tronche, 38700, France

RECRUITING

CHU Nantes, Merz Investigational Site #0330068

Nantes, 44093, France

RECRUITING

Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398

Berlin, 10117, Germany

RECRUITING

Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394

Frankfurt, 65929, Germany

RECRUITING

Universitätsmedizin Greifswald, Merz Investigational Site #0490397

Greifswald, 17475, Germany

RECRUITING

Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396

Kassel, 34131, Germany

RECRUITING

Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395

Kiel, 24149, Germany

RECRUITING

Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023

Florence, 50134, Italy

RECRUITING

Ospedale San Raffaele, Merz Investigational Site #0390027

Milan, 20132, Italy

RECRUITING

Istituto Auxologico Italiano, Merz Investigational Site #0390024

Milan, 20149, Italy

RECRUITING

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

Pavia, 27100, Italy

RECRUITING

IRCCS San Raffaele Roma, Merz Investigational Site #0390026

Roma, 00166, Italy

RECRUITING

Centrum Medyczne Neuromed, Merz Investigational Site #0480117

Bydgoszcz, 85-163, Poland

RECRUITING

AthleticoMed, Merz Investigational Site #0480127

Bydgoszcz, 85-752, Poland

RECRUITING

ETG Debica, Merz Investigational Site #0480121

Dębica, 39-200, Poland

RECRUITING

Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126

Gdynia, 81-338, Poland

RECRUITING

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

Katowice, 40-282, Poland

RECRUITING

Jan Banach Research Spot, Merz Investigational Site #0480059

Krakow, 30-539, Poland

RECRUITING

Pratia MCM, Merz Investigational Site #0480087

Krakow, 30-727, Poland

RECRUITING

FutureMeds, Merz Investigational Site #0480125

Krakow, 31-501, Poland

RECRUITING

Krakowska Akademia Neurologii, Merz Investigational Site #0480031

Krakow, 31-505, Poland

RECRUITING

Neurocor, Merz Investigational Site #0480119

Krakow, 31-870, Poland

RECRUITING

Clinirem, Merz Investigational Site #0480128

Lublin, 20-064, Poland

RECRUITING

ETG Lublin, Merz Investigational Site #0480118

Lublin, 20-412, Poland

RECRUITING

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

Lublin, 20-582, Poland

RECRUITING

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

Oświęcim, 32-600, Poland

RECRUITING

Solumed Centrum Medyczne, Merz Investigational Site #0480122

Poznan, 60-529, Poland

RECRUITING

ETG Neuroscience, Merz Investigational Site #0480116

Warsaw, 02-677, Poland

RECRUITING

MIGRE Polskie Centrum Leczenia Migreny, Merz Investigational Site #0480124

Wroclaw, 52-210, Poland

RECRUITING

Futuremeds, Merz Investigational Site #0480123

Wroclaw, 53-673, Poland

RECRUITING

ETG Zamosc, Merz Investigational Site #0480120

Zamość, 22-400, Poland

RECRUITING

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

Banská Bystrica, 974 04, Slovakia

RECRUITING

KONZÍLIUM, Merz Investigational Site #4210011

Dubnica nad Váhom, 018 41, Slovakia

RECRUITING

NEURES, Merz Investigational Site #4210006

Krompachy, 053 42, Slovakia

RECRUITING

Liptovská nemocnica s poliklinikou, Merz Investigational Site #4210013

Liptovský Mikuláš, 031 23, Slovakia

RECRUITING

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

Barcelona, 08006, Spain

RECRUITING

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

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre, Merz Investigational Site #0340055

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz, Merz Investigational Site #0340007

Madrid, 28046, Spain

RECRUITING

Campus Blua Sanitas Valdebebas Hospital, Merz Investigational Site #0340057

Madrid, 28055, Spain

RECRUITING

Hospital Regional Universitario de Malaga, Merz Investigational Site #0340050

Málaga, 29010, Spain

RECRUITING

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

Málaga, 29010, Spain

RECRUITING

Hospital Vithas Malaga, Merz Investigational Site #0340054

Málaga, 29016, Spain

RECRUITING

Hospital Universitario Virgen del Rocio, Merz Investigational Site #0340046

Seville, 41013, Spain

RECRUITING

Consorci Sanitari de Terrassa, Merz Investigational Site #0340051

Terrassa, 08227, Spain

RECRUITING

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

Valencia, 46026, Spain

RECRUITING

Complejo Hospitalario Universitario de Vigo, Merz Investigational Site #0340052

Vigo, 36312, Spain

RECRUITING

Hospital Viamed Montecanal, Merz Investigational Site #0340053

Zaragoza, 50012, Spain

RECRUITING

Kopfwehzentrum Hirslanden, Merz Investigational Site #0410017

Zollikon, 8702, Switzerland

RECRUITING

Royal Stoke University Hospital, Merz Investigational Site #0440048

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Merz Medical Expert

  Merz Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Public Disclosure Manager

CONTACT

+49691503; clinicaltrials@merz.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5); GB (1); CH (1); IT (5); FR (3); PL (19); AU (2); SL (4); ES (13); DK (1); CA (2); US (45); DE (5)