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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: Recruiting Phase 3 study of Chronic Migraine, sponsored by Naval Medical Center Camp Lejeune.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To compare the difference in headache days per month (incobotulinumtoxinA (XEOMIN®) relative to onabotulinumtoxinA (BOTOX®)) at the end of treatment period (24 weeks).
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 |
What NCT05598723 shows while recruiting
NCT05598723 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 336-participant average among 17 other Chronic Migraine trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05598723's enrollment target sits among peer trials
128 11th of 17 higher than 7 of 17 other Chronic Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
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-
A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
RECRUITING · Phase 3
-
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults
ACTIVE NOT RECRUITING · Phase 3
-
Responding With Evidence and Access for Childhood Headaches
RECRUITING · NA
-
Determining the Utility of a Behavioral Intervention in Chronic Migraine
RECRUITING · NA
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