BOTOX® vs. XEOMIN® for Chronic Migraine

Part of paid clinical trials in Jacksonville, North Carolina.

Sponsor
Naval Medical Center Camp Lejeune
Study ID
NCT05598723
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 24, 2023
Status verified
Dec 2024
Primary completion
Feb 24, 2026
Completion
Aug 24, 2026

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: OnabotulinumtoxinA (BOTOX®)
    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.
  • Experimental: IncobotulinumtoxinA (XEOMIN®)
    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.

Primary Outcome Measure

Headache days per month [ Time Frame: 24 weeks + Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Naval Medical Center Camp LejeuneJacksonvilleNorth Carolina28547
Keely Klaumann, BS
[email protected]
910-226-2258

Find similar trials in Jacksonville, NC

By condition
Migraine
By specialty
Neurology
By research site
Naval Medical Center Camp Lejeune· Jacksonville, NC

Related Studies