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

RecruitingPhase 3

Sponsor: Merz Therapeutics GmbH

Conditions: Episodic Migraine

Interventions: Xeomin, Placebo

Countries: United States, Austria, Canada, Czechia, Denmark, France, Germany, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (109)

Chandler, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Lancaster, California, United States
Los Angeles, California, United States
Thousand Oaks, California, United States
Torrance, California, United States
New Haven, Connecticut, United States
New Haven, Connecticut, United States
Stamford, Connecticut, United States
Gulf Breeze, Florida, United States
Homestead, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Decatur, Georgia, United States
Honolulu, Hawaii, United States
Overland Park, Kansas, United States
Chalmette, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Waltham, Massachusetts, United States
Westborough, Massachusetts, United States
Dearborn Heights, Michigan, United States
Farmington Hills, Michigan, United States
Rochester, Minnesota, United States
City of Saint Peters, Missouri, United States
Omaha, Nebraska, United States
Amherst, New York, United States
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