Comparison of BOTOX4 and XEOMIN4 Injections for Treating Chronic Migraine in Adults

What this Trial Is About

Chronic migraine is a disabling condition that affects active duty military personnel and veterans, leading to impaired cognition and reduced quality of life. This study evaluates two treatments for chronic migraine onabotulinumtoxinA BOTOX4 and incobotulinumtoxinA XEOMIN4. The goal is to find an effective treatment that does not require refrigeration, which is important for members deployed in environments with limited storage options. Both treatments are botulinum toxins with comparable strength, and this Phase 3 randomized study compares their effects in adults with chronic migraine. Participants will be randomly assigned to receive either onabotulinumtoxinA or incobotulinumtoxinA. Each treatment involves 31 injections of 5 units each, totaling 155 units, administered in the head and neck at two sessions spaced 12 weeks apart. Injection sites include the forehead, temples, back of the head, upper neck, and shoulder-neck junction. The study measures changes in headache days and impact using validated questionnaires at baseline, 12 weeks, and 24 weeks. Participants will keep an electronic diary to record headache days, severity, and any adverse effects. Assessments include the Headache Impact Test-6 HIT-6 and the Migraine Specific Quality MSQ Questionnaire to evaluate headache impact and quality of life. The primary outcome is the change in headache days between 12 and 24 weeks after treatment. Secondary outcomes include changes in headache impact and health-related quality of life. The study lasts at least 24 weeks, with ongoing monitoring of participant experience and safety.

BOTOX® vs. XEOMIN® for Chronic Migraine