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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Xeomin

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

DRUG

Placebo

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)

Locations (20)

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
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