Xeomin Injections for Chronic Migraine

This clinical trial is studying whether Xeomin injections can help prevent chronic migraine. Xeomin is a drug that works as a monoclonal antibody. Participants with chronic migraine will receive injections of either Xeomin or a placebo (an inactive substance) into muscles in their head and neck. The main goal is to see how much the number of monthly migraine days changes after 6 months of treatment. To join, you must be at least 18 years old, have been diagnosed with chronic migraine for at least 12 months, and have experienced migraine onset before age 50. The study aims to enroll 780 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 780 participants with chronic migraine. Participants will receive either Xeomin or a placebo.
What's involved
You would participate for 52 to 55 weeks, including a 4-5 week screening period and 4 treatments given about 12 weeks apart. There will be 14 visits in total, with 6 on-site and 8 remote (phone/video call).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in migraine days up to Month 6 (weeks 21 to 24) after the first injection.

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NCT07018713

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merz Therapeutics GmbH
~780 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:XeominPlacebo

At a glance

Recruiting sites
110 of 110 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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 over Baseline to month 6
Chronic Migraine
110 sites across 36 states
Poland19
Spain13
Florida7
New York6
Czechia5
Germany5
Italy5
California4
  • Merz Medical Expert · STUDY_DIRECTOR · Merz Therapeutics

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Eligibility criteria

Inclusion

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

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.
  • Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose ABaseline to month 6