BOTOX® vs. XEOMIN® for Chronic Migraine

This study is comparing two approved medications, BOTOX® (onabotulinumtoxinA) and XEOMIN® (incobotulinumtoxinA), to see which is more effective at reducing chronic migraine headaches. Researchers want to find out if one drug leads to fewer headache days per month. You might be able to join if you are between 18 and 89 years old, experience 15 or more headache days per month, and are a Department of Defense (DoD) Beneficiary/TriCare Eligible. You also need to have tried and not responded well to at least two other migraine medications. The study is currently unclear on its recruitment status.

Study design: This study is an interventional trial with 128 participants. Participants will be randomly assigned to receive either BOTOX® or XEOMIN®.
What's involved: You would receive injections of either BOTOX® or XEOMIN® twice, 12 weeks apart. You would also complete an electronic diary to track headache days and side effects, and fill out questionnaires at the beginning, 12 weeks, and 24 weeks into the study.
Compensation: Not stated in the trial record.
Follow-up: Your headache days will be measured at 24 weeks after the start of the study, and questionnaires will be administered at 12 and 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

BOTOX® vs. XEOMIN® for Chronic Migraine

Recruiting

PHASE3Ages 18–89InterventionalTreatment

Naval Medical Center Camp Lejeune

~128 participants

Updated 2026-07-22 on ClinicalTrials.gov

What's tested:IncobotulinumtoxinA (XEOMIN®)OnabotulinumtoxinA (BOTOX®)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Headache days per month

Measured over 24 weeks + Baseline

Conditions

Chronic Migraine

Where it's being run

1 sites across 1 states

North Carolina1

Study leadership

Jacqueline S Buckley, PharmD · PRINCIPAL_INVESTIGATOR · Naval Medical Center Camp Lejeune

Who to contact

Jacqueline S Buckley, PharmD

[email protected]

(910) 443-2783

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Headache days per month24 weeks + Baseline
To compare the difference in headache days per month (incobotulinumtoxinA (XEOMIN®) relative to onabotulinumtoxinA (BOTOX®)) at the end of treatment period (24 weeks).

Trialytics