Comparing BOTOX® and XEOMIN® for treating chronic migraine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy of two botulinum toxin treatments, BOTOX® (onabotulinumtoxinA) and XEOMIN® (incobotulinumtoxinA), in reducing the frequency of chronic migraine headaches among active duty personnel and eligible dependents. A total of 128 participants will be randomly assigned to receive either treatment, with injections administered twice, 12 weeks apart. The primary outcome will be measured by the change in headache days from baseline to 24 weeks post-treatment, alongside assessments of headache severity and quality of life through standardized questionnaires. Participants will maintain an electronic diary to track their headache occurrences and any side effects throughout the study period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Naval Medical Center Camp Lejeune
  Jacksonville, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Jacqueline S Buckley, PharmD — Naval Medical Center Camp Lejeune
• Study coordinator: Jacqueline S Buckley, PharmD
• Email: jacqueline.s.buckley.civ@health.mil
• Phone: (910) 443-2783

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nebulized dexmedetomidine for early chronic migraine

  This study tests whether inhaled dexmedetomidine can lessen central sensitization and help prevent chronification in people with early chronic migraine.

  Recruiting Beni-Suef University · Banī Suwayf · NCT07769255

• i-NEED: New migraine drugs database

  This project will collect real-life data to see how new migraine treatments—anti‑CGRP antibodies, gepants, ditans, and a sumatriptan‑naproxen combo—work and how well adults with episodic or chronic migraine tolerate them.

  Recruiting at 2 sites IRCCS San Raffaele Roma · Milan, Italy and 1 other locations · NCT07103694

• Suppressive Functions of Regulatory T Cells in Migraine

  This study tests whether regulatory T cells can help control migraine-related inflammation in adults with chronic migraine.

  Recruiting University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT07067112

• Comparing sphenopalatine block and BOTOX for chronic migraine relief

  This study is testing whether a nerve block or BOTOX injections can help people with chronic migraines feel better.

  Recruiting Cairo University · Cairo · NCT06974617

• Using Atogepant tablets to prevent migraines in teens aged 12 to 17

  This study is testing if Atogepant tablets can help prevent migraines in teenagers aged 12 to 17.

  Recruiting at 61 sites Phase 3 AbbVie · Huntsville, Alabama and 65 other locations · NCT06810505

• Acceptance and Commitment Therapy to reduce disability in adults with chronic migraine

  This trial will test whether adding Acceptance and Commitment Therapy (ACT) to usual care helps adults with chronic migraine improve daily functioning and reduce headache frequency and pain.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT06795867

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.