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

What this study is about

In this clinical trial, participants with episodic 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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• 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
• Clinical Trials Management Services, Merz Investigational Site #0010526, Thousand Oaks, California, United States
• BNL Health Inc., Merz Investigational Site #0010489, Torrance, 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
• Northwest Florida Clinical Research Group, Merz Investigational Site #0010286, Gulf Breeze, Florida, United States
• Nexus Clinical Research Center, Merz Investigational Site #0010514, Homestead, Florida, United States

+ 96 more sites.

Who to contact

Public Disclosure Manager · +49691503 · clinicaltrials@merz.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07018700.