BOTOX® vs. XEOMIN® for Chronic Migraine

Launched by NAVAL MEDICAL CENTER CAMP LEJEUNE · Oct 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two medications, BOTOX® and XEOMIN®, to see which one works better for treating chronic migraine (CM). Chronic migraine is a condition that can cause severe headaches and affects daily life, especially for active duty military personnel and veterans. The trial aims to find out if XEOMIN, which does not need refrigeration, is an effective alternative to BOTOX, which has to be kept cold and may not be accessible in certain situations like deployment.

To be eligible for this study, participants need to be between the ages of 18 and 89 and experience at least 15 headache days each month that last for four hours or longer. They also must have tried two different types of migraine medications without success. Participants will be asked to provide informed consent and complete assessments, and women will need to take a pregnancy test before joining. If you join the trial, you’ll have regular follow-up visits to check on your progress. This research is important because it seeks to provide more treatment options for chronic migraine, especially in challenging situations where access to certain medications is limited.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Between ages of 18-89
• • 15 or more headaches days experienced per month lasting 4 hours or longer
• • Department of Defense (DoD) Beneficiary/TriCare Eligible
• • Failure, contraindication or intolerance to two migraine medications from two different classes.
• • Able to provide informed consent and be able to read and write English.
• • Able to read, comprehend, and complete the assessment and diary
• • Women must provide a negative urine pregnancy test
• Exclusion Criteria:
• • Currently pregnant, breastfeeding, or planning to become pregnant
• • Allergic to botulinum toxin or to any of the ingredients of the medication
• • Has myasthenia gravis, amyotrophic lateral sclerosis, or Eaton Lambert syndrome, mitochondrial disease, fibromyalgia, any temporomandibular disfunction, or any other significant disease that might interfere with neuromuscular function.
• • Uncontrolled epilepsy defined as more than 1 generalized seizure in any month within the 3 months prior to the day 0 visit
• • Those on oral anticoagulation
• • Previous botulinum toxin treatment on the cephalic/upper lumbar region within 6 months for any indication
• • Localized infections on face, neck or on antibiotics for areas in this region
• • Unable to attend study follow up visits for any reason (i.e. Training, deployment, or PCS)
• • Use of any prophylactic headache medication between -4 weeks and week 0 visits
• • Any person taking chronic pain medication for a chronic indication
• • Any diagnosed psychiatric condition which would prohibit a participant from completing the trial in its totality.