NCT05598723 BOTOX® vs. XEOMIN® for Chronic Migraine
| NCT ID | NCT05598723 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Naval Medical Center Camp Lejeune |
| Condition | Chronic Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2023-02-24 |
| Primary Completion | 2027-02-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 128 participants in total. It began in 2023-02-24 with a primary completion date of 2027-02-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jacqueline S Buckley, PharmD
PRINCIPAL INVESTIGATOR
Naval Medical Center Camp Lejeune
Frequently Asked Questions
Who can join the NCT05598723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Chronic Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05598723 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 128 participants.
Is NCT05598723 currently recruiting?
Yes, NCT05598723 is actively recruiting participants. Contact the research team at jacqueline.s.buckley.civ@health.mil for enrollment information.
Where is the NCT05598723 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT05598723 clinical trial?
NCT05598723 is sponsored by Naval Medical Center Camp Lejeune. The principal investigator is Jacqueline S Buckley, PharmD at Naval Medical Center Camp Lejeune. The trial plans to enroll 128 participants.
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