BOTOX® vs. XEOMIN® for Chronic Migraine

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified November 2024 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 24, 2022
First Posted
October 27, 2022
Last Update Posted
May 14, 2025
Last Verified
November 2024

ClinicalTrials.gov processed this data on May 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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 DiseaseIntervention/Treatment
Chronic Migraine
Drug: OnabotulinumtoxinA (BOTOX®)Drug: IncobotulinumtoxinA (XEOMIN®)

Study Design

Study TypeInterventional
Actual Enrollment128 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine
Study Start DateFebruary 23, 2023
Actual Primary Completion DateFebruary 23, 2026
Actual Study Completion Date3mos 1w from now

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®)
OnabotulinumtoxinA (BOTOX®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.
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
    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
    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
    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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 CollaboratorsNaval Medical Center Camp Lejeune
Locations
Naval Medical Center Camp Lejeune | Jacksonville North Carolina, United States, 28547
Investigators
Principal Investigator: Jacqueline S Buckley, PharmD, Naval Medical Center Camp Lejeune