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

Launched by MERZ THERAPEUTICS GMBH · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of Xeomin® injections in preventing episodic migraines, which are headaches that occur less frequently than chronic migraines. Participants will receive either Xeomin injections or a placebo (a substance with no active medication) in the muscles of their head and neck. The goal is to see if those receiving Xeomin have fewer migraine days each month compared to those receiving the placebo. The trial will last about a year, with participants visiting the clinic for their initial and final appointments, as well as during the four treatment sessions. Other check-ins will be conducted remotely through phone or video calls.

To be eligible for the trial, participants must have a diagnosis of episodic migraine for at least a year and experience between 6 and 14 migraine days a month. They should be under 50 years old when their migraines started and have a history of fewer than 14 headache days each month. It’s important to note that individuals with chronic migraines or certain other types of headaches will not be able to participate. This study is not yet recruiting, but it aims to provide valuable information about how Xeomin may help reduce the frequency of migraines for those who suffer from them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant has a diagnosis of EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) 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 ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and
• • During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary.
• Exclusion Criteria:
• • Diagnosis of chronic migraine;
• • 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.