Single Center Study on the Sustained Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine

ClinicalTrials.gov processed this data on November 14, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified November 2023 by Naval Medical Center Camp Lejeune

Sponsor

Naval Medical Center Camp Lejeune

Information Provided by (Responsible Party)

Naval Medical Center Camp Lejeune

Clinicaltrials.gov Identifier

NCT05598723
Other Study ID Numbers: NMCCL.2022.0029
First Submitted: October 25, 2022
First Posted: October 28, 2022
Last Update Posted: November 15, 2023
Last Verified: November 2023
History of Changes

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.

Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.

Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.

For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.

See also the Web Policies and Notices for the NIH web site.

Study 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.
Condition or Disease Intervention/Treatment
  • Chronic Migraine
  • Drug: IncobotulinumtoxinA (XEOMIN®)
  • Drug: OnabotulinumtoxinA (BOTOX®)

Study Design

Study TypeInterventional
Anticipated Enrollment128 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleSingle Center Study on the Sustained Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine
Study Start DateFebruary 24, 2023
Anticipated Primary Completion DateFebruary 24, 2025
Anticipated Study Completion DateAugust 24, 2025

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • 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®)
    • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Headache days per month [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).

    Secondary Outcome Measures

    1. Differences in headache impact [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.
    2. Differences in Health-Related Quality of Life [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.

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 89 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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.

    Contacts and Locations

    Sponsors and Collaborators Naval Medical Center Camp Lejeune
    Locations
    • Naval Medical Center Camp Lejeune | Jacksonville, North Carolina, United States, 28547
    Investigators
    • Principal Investigator: Kathleen T Tilman, MD, Naval Medical Center Camp Lejeune

    More Information

    Publications

    Additional Relevant MeSH Terms

    • Migraine Disorders
    • Headache Disorders, Primary
    • Headache Disorders
    • Brain Diseases
    • Central Nervous System Diseases
    • Nervous System Diseases