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BOTOX® vs. XEOMIN® for Chronic Migraine

Primary Purpose

Chronic Migraine

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

IncobotulinumtoxinA (XEOMIN®)

OnabotulinumtoxinA (BOTOX®)

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring Botox, Xeomin, onabotulinumtoxinA, incobotulinumtoxinA, Botulinum Toxin, refrigeration, HIT-6

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Naval Medical Center Camp LejeuneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

OnabotulinumtoxinA (BOTOX®)

IncobotulinumtoxinA (XEOMIN®)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Headache days per month

To compare the difference in headache days per month (incobotulinumtoxinA (XEOMIN®) relative to onabotulinumtoxinA (BOTOX®)) at the end of treatment period (24 weeks).

Secondary Outcome Measures

Differences in headache impact

Assessed using the Headache Impact Test-6 (HIT-6): mean change from baseline will be reported. HIT-6 score ranges between 36 and 78, with larger scores reflecting greater impact.

Differences in Health-Related Quality of Life

Assessed using the Migraine Specific Quality (MSQ) Questionnaire: mean change from baseline will be reported. MSQ score ranges between 0-100 scale, with higher scores signifying better health-related quality of life.

Full Information

NCT ID

NCT05598723

First Posted

October 25, 2022

Last Updated

March 3, 2023

Sponsor

Naval Medical Center Camp Lejeune

1. Study Identification

Unique Protocol Identification Number

NCT05598723

Brief Title

BOTOX® vs. XEOMIN® for Chronic Migraine

Official Title

Single Center Study on the Sustained Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 24, 2023 (Actual)

Primary Completion Date

February 24, 2025 (Anticipated)

Study Completion Date

August 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Naval Medical Center Camp Lejeune

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Migraine

Keywords

Botox, Xeomin, onabotulinumtoxinA, incobotulinumtoxinA, Botulinum Toxin, refrigeration, HIT-6

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

A randomized, double blind, prospective, parallel-group study (non-inferiority trial)

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OnabotulinumtoxinA (BOTOX®)

Arm Type

Active Comparator

Arm Description

Arm Title

IncobotulinumtoxinA (XEOMIN®)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

IncobotulinumtoxinA (XEOMIN®)

Other Intervention Name(s)

Xeomin

Intervention Description

IncobotulinumtoxinA (XEOMIN®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.

Intervention Type

Drug

Intervention Name(s)

OnabotulinumtoxinA (BOTOX®)

Other Intervention Name(s)

Botox

Intervention Description

OnabotulinumtoxinA (BOTOX®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.

Primary Outcome Measure Information:

Title

Headache days per month

Description

To compare the difference in headache days per month (incobotulinumtoxinA (XEOMIN®) relative to onabotulinumtoxinA (BOTOX®)) at the end of treatment period (24 weeks).

Time Frame

24 weeks + Baseline

Secondary Outcome Measure Information:

Title

Differences in headache impact

Description

Assessed using the Headache Impact Test-6 (HIT-6): mean change from baseline will be reported. HIT-6 score ranges between 36 and 78, with larger scores reflecting greater impact.

Time Frame

24 weeks vs. Baseline

Title

Differences in Health-Related Quality of Life

Description

Time Frame

24 weeks vs. Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kathleen T Tilman, MD

Phone

‪(910) 226-2258‬

kathleen.t.tilman.mil@health.mil

First Name & Middle Initial & Last Name or Official Title & Degree

Mario G Oyola, PhD

mario.g.oyola.ctr@health.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen T Tilman, MD

Organizational Affiliation

Naval Medical Center Camp Lejeune

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mario G Oyola, PhD

Organizational Affiliation

Naval Medical Center Camp Lejeune

Official's Role

Study Director

Facility Information:

Facility Name

Naval Medical Center Camp Lejeune

City

Jacksonville

State/Province

North Carolina

ZIP/Postal Code

28547

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shannon Y Kelly, BS

Phone

910-226-2258

shannon.y.kelly.ctr@health.mil

12. IPD Sharing Statement

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BOTOX® vs. XEOMIN® for Chronic Migraine

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