Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial With Extension to Evaluate Xeomin Injections for Preventing Episodic Migraine
Led by Merz Therapeutics GmbH · Updated on 2026-05-08
990
Participants Needed
108
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Xeomin injections to prevent episodic migraine by comparing its effects to placebo injections. The study focuses on adults with episodic migraine who experience a limited number of migraine and headache days per month. The main goal is to measure changes in the number of monthly migraine days after treatment. Participants receive Xeomin or placebo injections in muscles of the head and neck at specific points. The study includes two Xeomin dose groups and a placebo group, with an extension period where placebo participants may receive Xeomin. Four treatments are given roughly 12 weeks apart during a trial lasting about 52 to 55 weeks. Participants attend 14 visits over the course of the study, with the first, last, and four treatment visits conducted in person. The remaining visits occur remotely via phone or video call. Researchers monitor migraine frequency changes, medication use, and any treatment-related adverse events. The primary outcome is the change in monthly migraine days after six months of treatment.
CONDITIONS
Brief Title
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with episodic migraine with or without aura for at least 12 months
- Able to distinguish migraine headaches from other headache types
- Migraine onset before age 50
- History of 6 to 14 migraine days per month and 14 or fewer headache days per month in the 3 months before screening
- During the last 28 days of screening, experiencing 6 to 14 migraine days and 14 or fewer headache days as recorded in a headache diary
You will not qualify if you...
- Diagnosis of chronic migraine
- Diagnosis of primary headache types other than tension-type headache
- Diagnosis of specific migraine types such as aura without headache, 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
- Taking more than one prescribed drug for preventive migraine treatment
- Stopped anti-CGRP or anti-CGRP receptor antibody treatment less than 5 months before screening
Research Team
P
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