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

Launched by MERZ THERAPEUTICS GMBH · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of Xeomin® injections to help prevent chronic migraines. Chronic migraine is when someone has headaches on 15 or more days each month, which can really affect their daily life. In this trial, participants will receive either Xeomin injections or a placebo (a substance with no active ingredients) in the head and neck muscles. The goal is to see if those who receive Xeomin have fewer migraine days than those who receive the placebo.

To be eligible for this trial, participants should be under 50 years old when their migraines started and must have a history of experiencing at least 15 headache days and 8 migraine days each month for several months. During the trial, which lasts about a year, participants will have 14 visits—some in person and some through phone or video calls. This will include four treatment sessions spaced about three months apart. It's important to note that the trial is not yet recruiting participants, so interested individuals will need to wait for that process to begin.

Gender

ALL

Eligibility criteria

• 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.