BOTOX® vs. XEOMIN® for Chronic Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for chronic migraines in military personnel and their families. The treatment involves injections into the head and neck to reduce the frequency and severity of migraines. This new treatment is particularly aimed at those who have not responded to other treatments.
Will I have to stop taking my current medications?
The trial requires that you stop taking any prophylactic headache medication 4 weeks before the study starts and during the trial. If you are on chronic pain medication for a chronic condition, you may not be eligible to participate.
Is BOTOX® or XEOMIN® safe for treating chronic migraine?
Is the drug XEOMIN® a promising treatment for chronic migraines?
What data supports the effectiveness of the drug for chronic migraine?
Research shows that XEOMIN® (IncobotulinumtoxinA) can significantly reduce the frequency of migraine episodes, headache days, and medication use in patients with chronic migraine. In a study, 73% of patients experienced more than a 50% reduction in migraine episodes, indicating its effectiveness as a preventive treatment.211121314
Who Is on the Research Team?
Jacqueline S Buckley, PharmD
Principal Investigator
Naval Medical Center Camp Lejeune
Are You a Good Fit for This Trial?
This trial is for Department of Defense beneficiaries aged 18-89 with chronic migraines, experiencing at least 15 headache days per month. Participants must have tried and not responded to two different migraine medications, be able to give informed consent in English, and attend follow-up visits. Pregnant or breastfeeding individuals, those allergic to botulinum toxin, on certain medications or with specific medical conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Establish baseline using headache days and questionnaires (HIT-6 and MSQ)
Treatment
Participants receive either onabotulinumtoxinA or incobotulinumtoxinA injections twice, 12 weeks apart
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- IncobotulinumtoxinA (XEOMIN®)
- OnabotulinumtoxinA (BOTOX®)
IncobotulinumtoxinA (XEOMIN®) is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Naval Medical Center Camp Lejeune
Lead Sponsor