A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial With Extension Period to Evaluate the Efficacy and Safety of Xeomin® Injections for the Prevention of Chronic Migraine
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Arizona Neuroscience Research, Merz Investigational Site #0010521
RECRUITING
Phoenix
California
Clinical Research Institute, Merz Investigational Site #0010487
RECRUITING
Los Angeles
Georgia
Accel Research - NeuroStudies, Merz Investigational Site #0010523
RECRUITING
Decatur
Louisiana
Crescent City Headache and Neurology Center, Merz Investigational Site #0010517
RECRUITING
Chalmette
DelRicht Clinical Research, Merz Investigational Site #0010518
RECRUITING
New Orleans
Massachusetts
Mass Institute of Clinical Research, Merz Investigational Site #0010506
RECRUITING
Westborough
Michigan
Vida Clinical Studies, Merz Investigational Site #0010498
RECRUITING
Dearborn Heights
Quest Research Institute, Merz Investigational Site #0010484
RECRUITING
Farmington Hills
Texas
Lone Star Neurology, Merz Investigational Site #0010497
RECRUITING
Frisco
Contact Information
Primary
Public Disclosure Manager
clinicaltrials@merz.com
+49691503
Time Frame
Start Date:2025-08-21
Estimated Completion Date:2028-03
Participants
Target number of participants:780
Treatments
Experimental: Xeomin Dose A
Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)
Experimental: Xeomin Dose B
Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)
Placebo_comparator: Placebo
Placebo-controlled period: Placebo injections at pericranial and cervical points.~Extension period: Xeomin injections at pericranial and cervical points (dose A)