RightFit
RecruitingPhase 3

BOTOX® vs. XEOMIN® for Chronic Migraine

A Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Injections of either treatment will occur twice, 12 weeks apart, in the head and neck regions."
  • "These questionnaires will also be administered at weeks 12 and 24 of the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares BOTOX and XEOMIN to help prevent chronic migraine, which causes frequent headaches. XEOMIN does not need to be kept cold. The study is for adults ages 18–89 who qualify for Department of Defense or TRICARE health benefits.

Chronic migraine (CM) is a disabling disorder that sidelines active duty personnel and diminishes their quality of life. It affects 1.3% to 2.4% of the general population. These numbers increase in active duty personnel, especially those returning from deployment, as well as in veterans. Furthermore, these numbers are 4-5 times higher in military members who experienced at least one mild traumatic brain injury. CM leads to impaired cognition and poor decision-making. These impairments on critical active duty tasks could have a significant impact on task readiness and military performance. Therefore, CM presents a challenge for the "return to duty" mission. Currently, onabotulinumtoxinA is the only FDA-approved prophylactic treatment for CM; however, this treatment requires refrigeration, to which there is little access for the forward-deployed members who have limited access to adequate storage for this treatment. Therefore, it is imperative to identify a CM treatment that does not require refrigeration. Furthermore, in light of the ongoing COVID-19 pandemic and resulting international shortages in critical medication production and delivery, it is imperative to identify more than one treatment option for the management of CM. In this study, we will test the efficacy of incobotulinumtoxinA, a neurotoxin that, unlike onabotulinumtoxinA, does not require refrigeration, but is an effective off-label alternative for the treatment of migraine. OnabotulinumtoxinA and incobotulinumtoxinA are comparable in strength, with a conversion ratio of 1:1.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–89 years old.
  • You have headaches on at least 15 days each month, lasting 4 hours or longer.
  • You qualify for Department of Defense or TRICARE health benefits.
  • Two migraine drugs from different groups did not work, were unsafe for you, or caused side effects you could not tolerate.
  • You can read and write English and agree to join after learning about the study.
  • You can read, understand, and complete the study forms and diary.
  • Women must have a negative urine pregnancy test.

Who can't join

  • You are pregnant, breastfeeding, or planning to become pregnant.
  • You are allergic to botulinum toxin, the drug in these treatments, or any of its ingredients.
  • You have myasthenia gravis, ALS, or Eaton-Lambert syndrome (nerve and muscle diseases); mitochondrial disease (a cell energy disorder); fibromyalgia (long-term widespread pain); jaw joint problems; or another serious disease affecting nerve and muscle function.
  • You had more than one generalized seizure, which affects both sides of the brain, in any month during the 3 months before the first study visit.
  • You take blood thinners by mouth, take ongoing pain medicine for a long-term condition, or use headache prevention medicine between the visit 4 weeks before treatment and the week 0 visit.
  • You had botulinum toxin treatment in your head or the upper part of your lower back within the past 6 months.
  • You have an infection in your face or neck, or take antibiotics for an infection in those areas.
  • You cannot attend follow-up visits, or a diagnosed mental health condition would keep you from finishing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NC