A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
Recruiting · NCT07018713 · Interventional (participants receive a specific treatment) · Lead sponsor: Merz Therapeutics GmbH
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboXeomin
What this trial is about
In this clinical trial, participants with chronic 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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 24 US states.
- 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
- BNL Health, Merz Investigational Site #0010501 - Los Angeles, California, United States
- Clinical Trials Management Services, Merz Investigational Site #0010526 - Thousand Oaks, 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
- Jacksonville Center for Clinical Research, Merz Investigational Site #0010515 - Jacksonville, Florida, United States
- Clinical Research of Central Florida, Merz Investigational Site #0010532 - Lakeland, Florida, United States
- University of Miami Miller School of Medicine, Merz Investigational Site #0010493 - Miami, Florida, United States
- American Research Institute, Merz Investigational Site #0010492 - Miami, Florida, United States
- Premiere Research Institute at Palm Beach Neurology, Merz Investigational Site #0010499 - West Palm Beach, Florida, United States
- Accel Research - NeuroStudies, Merz Investigational Site #0010523 - Decatur, Georgia, United States
- Hawaii Pacific Neuroscience, Merz Investigational Site #0010510 - Honolulu, Hawaii, United States
- Kansas Institute of Research,, Merz Investigational Site #0010495 - Overland Park, Kansas, United States
- Crescent City Headache and Neurology Center, Merz Investigational Site #0010517 - Chalmette, Louisiana, United States
- DelRicht Clinical Research, Merz Investigational Site #0010518 - New Orleans, Louisiana, United States
- Sinai Hospital of Baltimore, Merz Investigational Site #0010505 - Baltimore, Maryland, United States
- MedVadis Research, Merz Investigational Site #0010524 - Waltham, Massachusetts, United States
- Mass Institute of Clinical Research, Merz Investigational Site #0010506 - Westborough, Massachusetts, United States
- Vida Clinical Studies, Merz Investigational Site #0010498 - Dearborn Heights, Michigan, United States
- Quest Research Institute, Merz Investigational Site #0010484 - Farmington Hills, Michigan, United States
- Mayo Clinic, Merz Investigational Site #0010212 - Rochester, Minnesota, United States
- StudyMetrix Research, Merz Investigational Site #0010530 - City of Saint Peters, Missouri, United States
- Quality Clinical Research, Merz Investigational Site #0010522 - Omaha, Nebraska, United States
- Dent Neurosciences Research Center, Merz Investigational Site #0010486 - Amherst, New York, United States
- Integrative Clinical Trials, Merz Investigational Site #0010496 - Brooklyn, New York, United States
- New York Neurology Associates, Merz Investigational Site #0010500 - New York, New York, United States
- True North Neurology, Merz Investigational Site #0010508 - Port Jefferson Station, New York, United States
- Rochester Clinical Research, Merz Investigational Site #0010512 - Rochester, New York, United States
- Upstate Clinical Research Associates, Merz Investigational Site #0010485 - Williamsville, New York, United States
- Dayton Center for Neurological Disorders, Merz Investigational Site #0010531 - Centerville, Ohio, United States
- Headache Center of Hope, Merz Investigational Site #0010528 - Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center, Merz Investigational Site #0010491 - Cleveland, Ohio, United States
- Tekton Research, Merz Investigational Site #0010494 - Edmond, Oklahoma, United States
- Thomas Jefferson University, Merz Investigational Site #0010354 - Philadelphia, Pennsylvania, United States
- Coastal Neurology, Merz Investigational Site #0010503 - Port Royal, South Carolina, United States
- Alina Clinical Trials, Merz Investigational Site #0010511 - Dallas, Texas, United States
- Lone Star Neurology, Merz Investigational Site #0010497 - Frisco, Texas, United States
- MedStar Health - Department of Neurology, Merz Investigational Site #0010231 - McLean, Virginia, United States
- Gershon Pain Specialists, Merz Investigational Site #0010519 - Virginia Beach, Virginia, United States
- EvergreenHealth Research Department, Merz Investigational Site #0010516 - Kirkland, Washington, United States
- Gundersen Health System, Merz Investigational Site #0010507 - La Crosse, Wisconsin, United States
- MUDr. Beáta Dupejová, neurologická ambulancia, Merz Investigational Site #4210002 - Banská Bystrica, Slovakia
- Hospital Clinic de Barcelona-Hospital Plato, Merz Investigational Site #0340047 - Barcelona, Spain
- Hospital Universitari Vall d'Hebron, Merz Investigational Site #0340006 - Barcelona, Spain
- Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398 - Berlin, Germany
- Inselspital Bern, Merz Investigational Site #0410003 - Bern, Switzerland
- Pratia Brno, Merz Investigational Site #4200053 - Brno, Czechia
- Centrum Medyczne Neuromed, Merz Investigational Site #0480117 - Bydgoszcz, Poland
- AthleticoMed, Merz Investigational Site #0480127 - Bydgoszcz, Poland
- CHU Clermont Ferrand, Merz Investigational Site #0330026 - Clermont-Ferrand, France
- KONZÍLIUM, Merz Investigational Site #4210011 - Dubnica nad Váhom, Slovakia
- ETG Debica, Merz Investigational Site #0480121 - Dębica, Poland
- Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023 - Florence, Italy
Showing 60 of 111 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →