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NCT05598723 · ClinicalTrials.gov registry record · Phase 3
BOTOX® vs. XEOMIN® for Chronic Migraine
A Phase 3 study of Chronic Migraine, sponsored by Naval Medical Center Camp Lejeune.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 128
- Enrollment target
- 1
- Study location
NCT05598723 is a Phase 3 study of Chronic Migraine that is actively recruiting participants, run by Naval Medical Center Camp Lejeune. The registered enrollment target is 128 participants, below the 336-participant average among 17 other Chronic Migraine trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05598723, a Phase 3 study of Chronic Migraine, is actively recruiting participants, sponsored by Naval Medical Center Camp Lejeune.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 128 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG IncobotulinumtoxinA (XEOMIN®)
- DRUG OnabotulinumtoxinA (BOTOX®)
Study Locations (1)
North Carolina
- Naval Medical Center Camp Lejeune - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2023-02-24 |
| Est. Completion | 2026-08-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05598723
The ClinicalTrials.gov registry entry for NCT05598723 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 336-participant average among 17 other Chronic Migraine trials with a reported enrollment target (62% lower). The listed sponsor is Naval Medical Center Camp Lejeune, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Migraine appearing as the primary indexed condition, and to 2 interventions - of which IncobotulinumtoxinA (XEOMIN®) is the first listed.
NCT05598723 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05598723 about?
NCT05598723 is a clinical study titled "BOTOX® vs. XEOMIN® for Chronic Migraine". 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...
What is the current status of trial NCT05598723?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 128 participants. The study started on 2023-02-24. Estimated completion is 2026-08-24.
What conditions does trial NCT05598723 study?
This clinical trial studies the following conditions: Chronic Migraine.
What interventions are being tested in trial NCT05598723?
The interventions under investigation include: IncobotulinumtoxinA (XEOMIN®) (DRUG), OnabotulinumtoxinA (BOTOX®) (DRUG).
Who is sponsoring clinical trial NCT05598723?
This trial is sponsored by Naval Medical Center Camp Lejeune, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05598723 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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