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Neurotoxin

BOTOX® vs. XEOMIN® for Chronic Migraine

Phase 3

Recruiting

Led By Kathleen T Tilman, MD

Research Sponsored by Naval Medical Center Camp Lejeune

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks + baseline

Awards & highlights

Study Summary

This trial studies an alternative treatment for Chronic Migraine that does not require refrigeration and is comparable in strength to the current treatment. This could benefit active duty personnel, veterans and those impacted by the COVID-19 pandemic.

Who is the study for?

This trial is for Department of Defense beneficiaries aged 18-89 with chronic migraines, experiencing at least 15 headache days per month. Participants must have tried and not responded to two different migraine medications, be able to give informed consent in English, and attend follow-up visits. Pregnant or breastfeeding individuals, those allergic to botulinum toxin, on certain medications or with specific medical conditions are excluded.Check my eligibility

What is being tested?

The study compares BOTOX® (onabotulinumtoxinA), an FDA-approved treatment requiring refrigeration, with XEOMIN® (incobotulinumtoxinA), which doesn't need cooling and is effective off-label for migraines. The goal is to find a viable treatment option that's easier to store especially for military personnel in the field.See study design

What are the potential side effects?

Potential side effects from both treatments may include localized pain at injection sites, muscle weakness near where the medicine was injected, drooping eyelids, skin tightness or paresthesia ('pins and needles' sensation). Rarely more serious reactions can occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks + baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks + baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks + baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Headache

Secondary outcome measures

Differences in Health-Related Quality of Life

Headache

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IncobotulinumtoxinA (XEOMIN®)Experimental Treatment1 Intervention

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.

Group II: OnabotulinumtoxinA (BOTOX®)Active Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Naval Medical Center Camp LejeuneLead Sponsor

1 Previous Clinical Trials

2 Total Patients Enrolled

Mario G Oyola, PhDStudy DirectorNaval Medical Center Camp Lejeune

Kathleen T Tilman, MDPrincipal InvestigatorNaval Medical Center Camp Lejeune

Media Library

IncobotulinumtoxinA (XEOMIN®) (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05598723 — Phase 3

Migraine Research Study Groups: OnabotulinumtoxinA (BOTOX®), IncobotulinumtoxinA (XEOMIN®)

Migraine Clinical Trial 2023: IncobotulinumtoxinA (XEOMIN®) Highlights & Side Effects. Trial Name: NCT05598723 — Phase 3

IncobotulinumtoxinA (XEOMIN®) (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05598723 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who are over 30 years old able to participate in this research?

"This trial is specifically for patients that are between 18-89 years old. There are 33 other studies being conducted for patients under 18 and 114 for patients over 65."

Answered by AI

Could you please list the possible dangers of IncobotulinumtoxinA (XEOMIN®)?

"There is pre-existing clinical evidence to support the efficacy of IncobotulinumtoxinA as well as its safety, thus it received a score of 3."

Answered by AI

Do I fit the bill to take part in this research?

"To participate in this migraine study, patients must be aged 18-89 and have experienced 15 or more headache days per month, lasting 4 or more hours each, for at least the past 3 months. Additionally, women must provide a negative urine pregnancy test, patients must be eligible for Department of Defense benefits or TriCare, and they must be able to read and write English fluently in order to understand and complete the assessment and diary. Lastly, patients must have failed, contraindicated, or demonstrated intolerance to two different medications from two separate classes used to treat migraines."

Answered by AI