Ignite Creation Date:
2024-05-06 @ 6:14 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05598723
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2022-10-25
Brief Title:
BOTOX vs XEOMIN for Chronic Migraine
Sponsor:
Naval Medical Center Camp Lejeune
Organization:
Naval Medical Center Camp Lejeune
Study Overview
Official Title:
Single Center Study on the Sustained Effect of OnabotulinumtoxinA BOTOX vs IncobotulinumtoxinA XEOMIN Botulinum Toxin in Adults With Chronic Migraine
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic migraine CM is a disabling disorder that sidelines active duty personnel and diminishes their quality of life It affects 13 to 24 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 11
Detailed Description:
One hundred and twenty-eight male and female active duty personnel adult dependent and retiree patients from the Navy Medical Center at Camp Lejeune who meet the International Classification of Headache Disorders 3rd Edition ICHD-3 criteria of 15 headache days per month lasting 4 hours or longer will participate in the trial Subjects will be group-allocated randomly 64 to onabotulinumtoxinA and 64 to incobotulinumtoxinA Injections of either treatment will occur twice 12 weeks apart in the head and neck regions The primary treatment efficacy measurement will be the mean change in headache days 12 to 24 weeks post-treatment Participants will complete an electronic diary to report headache days their severity and adverse effects or unforeseen events A baseline will be established four weeks prior to the first botulinumtoxinA Botox or Xeomin administration using the number of headache days and two questionnaires Headache Impact Test-6 HIT-6 and the Migraine Specific Quality MSQ Questionnaire which assess headache impact and Health-Related Quality of Life HRQOL respectively These questionnaires will also be administered at weeks 12 and 24 of the study The baseline 12- and 24-week analysis will be performed using a time vs treatment repeated measures analysis of variance for headache days Secondary outcomes total scores of both the HIT-6 and MSQ will be analyzed similarly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None