BOTOX® vs. XEOMIN® for Chronic Migraine

NCT05598723 | Recruiting Phase 3 FDA Drug

• 1 other identifier: NMCCL.2022.0029
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Migraine

Keywords

Botox; Xeomin; onabotulinumtoxinA; incobotulinumtoxinA; Botulinum Toxin; refrigeration; HIT-6

Outcome Measures

Primary Outcomes (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).

  24 weeks + Baseline

Secondary Outcomes (2)

• Differences in headache impact

  24 weeks vs. Baseline

• Differences in Health-Related Quality of Life

  24 weeks vs. Baseline

Study Arms (2)

OnabotulinumtoxinA (BOTOX®)

ACTIVE COMPARATOR

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®)

EXPERIMENTAL

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®)

Interventions

IncobotulinumtoxinA (XEOMIN®) DRUG

IncobotulinumtoxinA (XEOMIN®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.

Also known as: Xeomin

IncobotulinumtoxinA (XEOMIN®)

OnabotulinumtoxinA (BOTOX®) DRUG

OnabotulinumtoxinA (BOTOX®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.

Also known as: Botox

OnabotulinumtoxinA (BOTOX®)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between ages of 18-89
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Naval Medical Center Camp Lejeune: lead

Study Sites (1)

Naval Medical Center Camp Lejeune

Jacksonville, North Carolina, 28547, United States

RECRUITING

Related Publications (22)

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MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Jacqueline S Buckley, PharmD

  Naval Medical Center Camp Lejeune

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline S Buckley, PharmD

CONTACT

(910) 443-2783; jacqueline.s.buckley.civ@health.mil

Keely C Klaumann, BS

CONTACT

(252) 732 - 8251; keely.c.klaumann.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: A randomized, double blind, prospective, parallel-group study (non-inferiority trial)

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: February 24, 2023
• Primary Completion: February 24, 2026
• Study Completion (Estimated): August 24, 2026
• Last Updated: May 15, 2025

Record last verified: 2024-12

Locations

US (1)