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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
780
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Arizona Neuroscience Research, Merz Investigational Site #0010521
Phoenix, Arizona, United States
RECRUITINGBaptist Health Medical Center, Merz Investigational Site #0010520
Little Rock, Arkansas, United States
RECRUITINGChemidox Clinical Trials Inc, Merz Investigational Site #0010488
Lancaster, California, United States
RECRUITINGClinical Research Institute, Merz Investigational Site #0010487
Los Angeles, California, United States
Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
Time frame: Baseline to month 6
Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B
Time frame: Baseline to month 6
Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
Time frame: Baseline to month 6
Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B
Time frame: Baseline to month 6
Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A
Time frame: Baseline to month 6
Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B
Time frame: Baseline to month 6
Change in frequency of migraine days from baseline (baseline monthly migraine days divided by 2) to two-week end-of-cycle periods (weeks 11 and 12 of Cycle 1 to 4)
Time frame: Baseline up to month 11
Percentage of participants who reported at least a 50% reduction in mean monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection)
Time frame: Baseline to month 6
Incidence of treatment-emergent adverse events (TEAEs) related to treatment as assessed by the investigator in the placebo-controlled period
Time frame: Month 6
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BNL Health, Merz Investigational Site #0010501
Los Angeles, California, United States
RECRUITINGClinical Trials Management Services, Merz Investigational Site #0010526
Thousand Oaks, California, United States
RECRUITINGHasbani Neurology, Merz Investigational Site #0010509
New Haven, Connecticut, United States
RECRUITINGNew England Institute Neurology and Headache, Merz Investigational Site #0010441
Stamford, Connecticut, United States
RECRUITINGNorthwest Florida Clinical Research Group, Merz Investigational Site #0010286
Gulf Breeze, Florida, United States
RECRUITINGNexus Clinical Research Center, Merz Investigational Site #0010514
Homestead, Florida, United States
RECRUITING...and 77 more locations