BOTOX® vs. XEOMIN® for Chronic Migraine

May 12, 2025 updated by: Naval Medical Center Camp Lejeune

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

One hundred and twenty-eight male and female active duty personnel, adult dependent and retiree patients from the Navy Medical Center at Camp Lejeune who meet the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria of ≥15 headache days per month lasting 4 hours or longer will participate in the trial. Subjects will be group-allocated randomly, 64 to onabotulinumtoxinA and 64 to incobotulinumtoxinA. Injections of either treatment will occur twice, 12 weeks apart, in the head and neck regions. The primary treatment efficacy measurement will be the mean change in headache days 12 to 24 weeks post-treatment. Participants will complete an electronic diary to report headache days, their severity, and adverse effects or unforeseen events. A baseline will be established four weeks prior to the first botulinumtoxinA (Botox or Xeomin) administration using the number of headache days and two questionnaires, Headache Impact Test-6 (HIT-6) and the Migraine Specific Quality (MSQ) Questionnaire, which assess headache impact and Health-Related Quality of Life (HRQOL), respectively. These questionnaires will also be administered at weeks 12 and 24 of the study. The baseline, 12-, and 24-week analysis will be performed using a time vs. treatment repeated measures analysis of variance for headache days. Secondary outcomes (total scores of both the HIT-6 and MSQ) will be analyzed similarly.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Jacksonville, North Carolina, United States, 28547

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OnabotulinumtoxinA (BOTOX®)
OnabotulinumtoxinA (BOTOX®) Group: Administration consists of 31 injections (5 onabotulinumtoxinA (BOTOX®) units per injection, for a total of 155units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections.
Drug: OnabotulinumtoxinA (BOTOX®)
OnabotulinumtoxinA (BOTOX®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.
Other Names:
  • Botox
Experimental: IncobotulinumtoxinA (XEOMIN®)
IncobotulinumtoxinA (XEOMIN®) Group: Administration consists of 31 injections (5 incobotulinumtoxinA (XEOMIN®) units per injection, for a total of 155 units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections.
Drug: IncobotulinumtoxinA (XEOMIN®)
IncobotulinumtoxinA (XEOMIN®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.
Other Names:
  • Xeomin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache days per month
Time Frame: 24 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).
24 weeks + Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in headache impact
Time Frame: 24 weeks vs. Baseline
Assessed using the Headache Impact Test-6 (HIT-6): mean change from baseline will be reported. HIT-6 score ranges between 36 and 78, with larger scores reflecting greater impact.
24 weeks vs. Baseline
Differences in Health-Related Quality of Life
Time Frame: 24 weeks vs. Baseline
Assessed using the Migraine Specific Quality (MSQ) Questionnaire: mean change from baseline will be reported. MSQ score ranges between 0-100 scale, with higher scores signifying better health-related quality of life.
24 weeks vs. Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naval Medical Center Camp Lejeune

Investigators

  • Principal Investigator: Jacqueline S Buckley, PharmD, Naval Medical Center Camp Lejeune

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2023

Primary Completion (Estimated)

February 24, 2026

Study Completion (Estimated)

August 24, 2026

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCCL.2022.0029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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