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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-21

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Xeomin Dose A

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

Group Type EXPERIMENTAL

Xeomin

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

Xeomin

Intervention Type DRUG

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)

Group Type PLACEBO_COMPARATOR

Xeomin

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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)

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz Therapeutics GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Baptist Health Medical Center, Merz Investigational Site #0010520

Little Rock, Arkansas, United States

Site Status RECRUITING

Chemidox Clinical Trials Inc, Merz Investigational Site #0010488

Lancaster, California, United States

Site Status RECRUITING

Clinical Research Institute, Merz Investigational Site #0010487

Los Angeles, California, United States

Site Status RECRUITING

BNL Health, Merz Investigational Site #0010501

Los Angeles, California, United States

Site Status RECRUITING

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

Stamford, Connecticut, United States

Site Status RECRUITING

Northwest Florida Clinical Research Group, Merz Investigational Site #0010286

Gulf Breeze, Florida, United States

Site Status RECRUITING

Nexus Clinical Research Center, Merz Investigational Site #0010514

Homestead, Florida, United States

Site Status RECRUITING

Jacksonville Center for Clinical Research, Merz Investigational Site #0010515

Jacksonville, Florida, United States

Site Status RECRUITING

Clinical Research of Central Florida, Merz Investigational Site #0010532

Lakeland, Florida, United States

Site Status RECRUITING

American Research Institute, Merz Investigational Site #0010492

Miami, Florida, United States

Site Status RECRUITING

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

West Palm Beach, Florida, United States

Site Status RECRUITING

Accel Research - NeuroStudies, Merz Investigational Site #0010523

Decatur, Georgia, United States

Site Status RECRUITING

Hawaii Pacific Neuroscience, Merz Investigational Site #0010510

Honolulu, Hawaii, United States

Site Status RECRUITING

Kansas Institute of Research,, Merz Investigational Site #0010495

Overland Park, Kansas, United States

Site Status RECRUITING

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

Chalmette, Louisiana, United States

Site Status RECRUITING

DelRicht Clinical Research, Merz Investigational Site #0010518

New Orleans, Louisiana, United States

Site Status RECRUITING

Sinai Hospital of Baltimore, Merz Investigational Site #0010505

Baltimore, Maryland, United States

Site Status RECRUITING

Mass Institute of Clinical Research, Merz Investigational Site #0010506

Westborough, Massachusetts, United States

Site Status RECRUITING

Vida Clinical Studies, Merz Investigational Site #0010498

Dearborn Heights, Michigan, United States

Site Status RECRUITING

Quest Research Institute, Merz Investigational Site #0010484

Farmington Hills, Michigan, United States

Site Status RECRUITING

StudyMetrix Research, Merz Investigational Site #0010530

City of Saint Peters, Missouri, United States

Site Status RECRUITING

Quality Clinical Research, Merz Investigational Site #0010522

Omaha, Nebraska, United States

Site Status RECRUITING

Dent Neurosciences Research Center, Merz Investigational Site #0010486

Amherst, New York, United States

Site Status RECRUITING

Integrative Clinical Trials, Merz Investigational Site #0010496

Brooklyn, New York, United States

Site Status RECRUITING

True North Neurology, Merz Investigational Site #0010508

Port Jefferson Station, New York, United States

Site Status RECRUITING

Rochester Clinical Research, Merz Investigational Site #0010512

Rochester, New York, United States

Site Status RECRUITING

Upstate Clinical Research Associates, Merz Investigational Site #0010485

Williamsville, New York, United States

Site Status RECRUITING

Dayton Center for Neurological Disorders, Merz Investigational Site #0010531

Centerville, Ohio, United States

Site Status RECRUITING

Headache Center of Hope, Merz Investigational Site #0010528

Cincinnati, Ohio, United States

Site Status RECRUITING

Tekton Research, Merz Investigational Site #0010494

Edmond, Oklahoma, United States

Site Status RECRUITING

Coastal Neurology, Merz Investigational Site #0010503

Port Royal, South Carolina, United States

Site Status RECRUITING

Alina Clinical Trials, Merz Investigational Site #0010511

Dallas, Texas, United States

Site Status RECRUITING

Lone Star Neurology, Merz Investigational Site #0010497

Frisco, Texas, United States

Site Status RECRUITING

Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042

Klagenfurt, , Austria

Site Status RECRUITING

CHU Nantes, Merz Investigational Site #0330068

Nantes, , France

Site Status RECRUITING

Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398

Berlin, , Germany

Site Status RECRUITING

Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394

Frankfurt, , Germany

Site Status RECRUITING

Universitätsmedizin Greifswald, Merz Investigational Site #0490397

Greifswald, , Germany

Site Status RECRUITING

Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396

Kassel, , Germany

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023

Florence, , Italy

Site Status RECRUITING

Istituto Auxologico Italiano, Merz Investigational Site #0390024

Milan, , Italy

Site Status RECRUITING

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

Pavia, , Italy

Site Status RECRUITING

Centrum Medyczne Neuromed, Merz Investigational Site #0480117

Bydgoszcz, , Poland

Site Status RECRUITING

AthleticoMed, Merz Investigational Site #0480127

Bydgoszcz, , Poland

Site Status RECRUITING

ETG Debica, Merz Investigational Site #0480121

Dębica, , Poland

Site Status RECRUITING

Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126

Gdynia, , Poland

Site Status RECRUITING

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

Katowice, , Poland

Site Status RECRUITING

Pratia MCM, Merz Investigational Site #0480087

Krakow, , Poland

Site Status RECRUITING

FutureMeds, Merz Investigational Site #0480125

Krakow, , Poland

Site Status RECRUITING

Krakowska Akademia Neurologii, Merz Investigational Site #0480031

Krakow, , Poland

Site Status RECRUITING

Neurocor, Merz Investigational Site #0480119

Krakow, , Poland

Site Status RECRUITING

ETG Lublin, Merz Investigational Site #0480118

Lublin, , Poland

Site Status RECRUITING

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

Lublin, , Poland

Site Status RECRUITING

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

Oświęcim, , Poland

Site Status RECRUITING

Solumed Centrum Medyczne, Merz Investigational Site #0480122

Poznan, , Poland

Site Status RECRUITING

ETG Neuroscience, Merz Investigational Site #0480116

Warsaw, , Poland

Site Status RECRUITING

MIGRE Polskie Centrum Leczenia Migreny, Merz Investigational Site #0480124

Wroclaw, , Poland

Site Status RECRUITING

Futuremeds, Merz Investigational Site #0480123

Wroclaw, , Poland

Site Status RECRUITING

ETG Zamosc, Merz Investigational Site #0480120

Zamość, , Poland

Site Status RECRUITING

KONZÍLIUM, Merz Investigational Site #4210011

Dubnica nad Váhom, , Slovakia

Site Status RECRUITING

NEURES, Merz Investigational Site #4210006

Krompachy, , Slovakia

Site Status RECRUITING

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

Barcelona, , Spain

Site Status RECRUITING

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

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre, Merz Investigational Site #0340055

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz, Merz Investigational Site #0340007

Madrid, , Spain

Site Status RECRUITING

Campus Blua Sanitas Valdebebas Hospital, Merz Investigational Site #0340057

Madrid, , Spain

Site Status RECRUITING

Hospital Regional Universitario de Malaga, Merz Investigational Site #0340050

Málaga, , Spain

Site Status RECRUITING

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

Málaga, , Spain

Site Status RECRUITING

Hospital Vithas Malaga, Merz Investigational Site #0340054

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocio, Merz Investigational Site #0340046

Seville, , Spain

Site Status RECRUITING

Consorci Sanitari de Terrassa, Merz Investigational Site #0340051

Terrassa, , Spain

Site Status RECRUITING

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

Valencia, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Vigo, Merz Investigational Site #0340052

Vigo, , Spain

Site Status RECRUITING

Hospital Viamed Montecanal, Merz Investigational Site #0340053

Zaragoza, , Spain

Site Status RECRUITING

Countries

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United States Austria France Germany Italy Poland Slovakia Spain

Central Contacts

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Public Disclosure Manager

Role: CONTACT

+49691503 ext. 3030

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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