Actively Recruiting

Phase 3
Age: 18Years - 89Years
All Genders
ID05598723

A Randomized, Double-Blind Study Comparing OnabotulinumtoxinA (BOTOX4) and IncobotulinumtoxinA (XEOMIN4) for Adults With Chronic Migraine

Led by Naval Medical Center Camp Lejeune · Updated on 2025-05-15

128

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic migraine is a disabling condition that affects both the general population and military personnel, especially those who have experienced mild traumatic brain injury. It impairs cognition and decision-making, which can impact military readiness. This trial evaluates two treatments: onabotulinumtoxinA (BOTOX4) and incobotulinumtoxinA (XEOMIN4), focusing on finding a treatment option that does not require refrigeration, which is important for deployed military members and addresses medication shortages during the COVID-19 pandemic. The study randomly assigns 128 participants to receive either onabotulinumtoxinA or incobotulinumtoxinA injections. Each participant will receive 31 injections of 5 units each (totaling 155 units) in the head and neck regions at two sessions spaced 12 weeks apart. Both treatments are administered using a very small, sharp needle at specific sites including the forehead, temples, back of the head, upper neck, and shoulder-neck junction. Participants will keep an electronic diary to track headache days, severity, and any side effects, starting with a 4-week baseline period before treatment. They will complete two questionnaires assessing headache impact and quality of life at baseline, 12 weeks, and 24 weeks. The main outcome measured is the change in headache days between 12 and 24 weeks after treatment. Safety and effectiveness are evaluated through these assessments and regular follow-up over 24 weeks.

CONDITIONS

Brief Title

BOTOX® vs. XEOMIN® for Chronic Migraine

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between ages of 18-89
  • Experiencing 15 or more headache days per month lasting 4 hours or longer
  • Eligible for Department of Defense (DoD) benefits or TriCare
  • Have failed, are intolerant to, or have contraindications for two different migraine medications
  • Able to provide informed consent and read and write English
  • Able to complete headache assessments and diary
  • Women must have a negative urine pregnancy test
Not Eligible

You will not qualify if you...

  • Currently pregnant, breastfeeding, or planning to become pregnant
  • Allergic to botulinum toxin or any ingredients of the medication
  • Have neuromuscular or neurological diseases like myasthenia gravis, amyotrophic lateral sclerosis, Eaton Lambert syndrome, mitochondrial disease, fibromyalgia, or temporomandibular dysfunction
  • Have uncontrolled epilepsy with more than one generalized seizure per month in the past 3 months
  • Taking oral anticoagulants
  • Had botulinum toxin treatment in the head or upper lumbar area within the past 6 months
  • Have localized infections on the face or neck or are on antibiotics for these areas
  • Unable to attend study follow-up visits due to training, deployment, or permanent change of station
  • Taking prophylactic headache medication between 4 weeks before and the start of the study
  • Taking chronic pain medication for a long-term condition
  • Have a diagnosed psychiatric condition that prevents completing the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants receive injections of either OnabotulinumtoxinA (BOTOX®) or IncobotulinumtoxinA (XEOMIN®) in the head and neck regions at two time points, 12 weeks apart.

2 injection visits 12 weeks apart

Follow-up

Duration - 24 weeks from baseline

Participants complete electronic diaries and questionnaires to report headache days, severity, and quality of life at baseline, 12 weeks, and 24 weeks.

3 assessment visits at baseline, 12 weeks, and 24 weeks

Trial Site Locations

Total: 1 location

1

Naval Medical Center Camp Lejeune

Jacksonville, North Carolina, United States, 28547

Actively Recruiting

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Research Team

J

Jacqueline S Buckley, PharmD

K

Keely C Klaumann, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The International Classification of Headache Disorders, 3rd edition (beta version).

Headache Classification Committee of the International Headache Society (IHS)

https://pubmed.ncbi.nlm.nih.gov/23771276

OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial.

S K Aurora, D W Dodick, C C Turkel...

https://pubmed.ncbi.nlm.nih.gov/20647170

OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial.

H C Diener, D W Dodick, S K Aurora...

https://pubmed.ncbi.nlm.nih.gov/20647171