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RECRUITINGPHASE3

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

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

NCT07018713•Merz Therapeutics GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (100)

TrialSphere Corp, Merz Investigational Site #0010513

Chandler, Arizona, United States

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

Clinical Trials Management Services, Merz Investigational Site #0010526

Thousand Oaks, California, United States

Hasbani Neurology, Merz Investigational Site #0010509

New Haven, Connecticut, United States

Yale Center for Clinical Investigations, Merz Investigational Site #0010527

New Haven, Connecticut, United States

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

Stamford, Connecticut, United States

Key Dates

Start Date

August 21, 2025

Primary Completion Date

October 1, 2027

Completion Date

March 1, 2028

Last Updated

March 20, 2026

Enrollment

780

ESTIMATED participants

Conditions

Chronic Migraine

Interventions

Xeomin

DRUG

Placebo

DRUG

Contacts

Public Disclosure Manager

CONTACT

+49691503 clinicaltrials@merz.com

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RECRUITINGPHASE3

A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years

NCT06810505

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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