128 Participants Needed

BOTOX® vs. XEOMIN® for Chronic Migraine

KY
MG
KT
JS
KC
Overseen ByKeely C Klaumann, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for chronic migraines in military personnel and their families. The treatment involves injections into the head and neck to reduce the frequency and severity of migraines. This new treatment is particularly aimed at those who have not responded to other treatments.

Will I have to stop taking my current medications?

The trial requires that you stop taking any prophylactic headache medication 4 weeks before the study starts and during the trial. If you are on chronic pain medication for a chronic condition, you may not be eligible to participate.

Is BOTOX® or XEOMIN® safe for treating chronic migraine?

Research shows that both BOTOX® (OnabotulinumtoxinA) and XEOMIN® (IncobotulinumtoxinA) have a good safety profile for treating chronic migraine, with studies demonstrating their safety over long-term use.12345

Is the drug XEOMIN® a promising treatment for chronic migraines?

Yes, XEOMIN® is considered a promising treatment for chronic migraines.678910

What data supports the effectiveness of the drug for chronic migraine?

Research shows that XEOMIN® (IncobotulinumtoxinA) can significantly reduce the frequency of migraine episodes, headache days, and medication use in patients with chronic migraine. In a study, 73% of patients experienced more than a 50% reduction in migraine episodes, indicating its effectiveness as a preventive treatment.211121314

Who Is on the Research Team?

JS

Jacqueline S Buckley, PharmD

Principal Investigator

Naval Medical Center Camp Lejeune

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Department of Defense (DoD) Beneficiary/TriCare Eligible
I experience 15 or more headache days each month, each lasting 4 hours or more.
Able to read, comprehend, and complete the assessment and diary
See 3 more

Exclusion Criteria

I am on long-term pain medication for a chronic condition.
I have a condition that could affect my muscle function.
I am taking blood thinners in pill form.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Baseline

Establish baseline using headache days and questionnaires (HIT-6 and MSQ)

4 weeks
1 visit (in-person)

Treatment

Participants receive either onabotulinumtoxinA or incobotulinumtoxinA injections twice, 12 weeks apart

24 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • IncobotulinumtoxinA (XEOMIN®)
  • OnabotulinumtoxinA (BOTOX®)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: IncobotulinumtoxinA (XEOMIN®)Experimental Treatment1 Intervention
Group II: OnabotulinumtoxinA (BOTOX®)Active Control1 Intervention

IncobotulinumtoxinA (XEOMIN®) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as XEOMIN for:
🇪🇺
Approved in European Union as XEOMIN for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Naval Medical Center Camp Lejeune

Lead Sponsor

Trials
3
Recruited
170+

Published Research Related to This Trial

In a study of 175 patients with chronic migraine, increasing the dose of onabotulinumtoxinA from 150 units to 200 units significantly reduced the number of headache days and severe headache days, indicating improved efficacy with higher doses.
The higher dose of onabotulinumtoxinA also led to a decrease in the duration of 'wearing off' periods, suggesting that patients experienced more consistent relief from migraines.
OnabotulinumtoxinA in chronic migraine: is the response dose dependent?Zandieh, A., Cutrer, FM.[2022]
In a study of 61 patients with refractory chronic migraine, XEOMIN® (Incobotulinumtoxin A) injections led to over 50% reductions in migraine frequency for 73% of participants, demonstrating its efficacy as a prophylactic treatment.
The treatment showed sustained benefits over an average duration of 21 months, with significant reductions in headache days and medication intake, indicating that XEOMIN® can be a reliable option for patients unresponsive to other treatments.
Monocentric Prospective Study into the Sustained Effect of Incobotulinumtoxin A (XEOMIN®) Botulinum Toxin in Chronic Refractory Migraine.Ion, I., Renard, D., Le Floch, A., et al.[2019]
OnabotulinumtoxinA has been approved for preventing chronic migraines, showing effectiveness in two large controlled trials.
Pragmatic studies in real-life settings have provided valuable insights for managing patients with chronic migraines, highlighting its importance in clinical practice.
Botulinum toxin for chronic migraine: Clinical trials and technical aspects.Tassorelli, C., Sances, G., Avenali, M., et al.[2018]

Citations

OnabotulinumtoxinA in chronic migraine: is the response dose dependent? [2022]
Monocentric Prospective Study into the Sustained Effect of Incobotulinumtoxin A (XEOMIN®) Botulinum Toxin in Chronic Refractory Migraine. [2019]
Botulinum toxin for chronic migraine: Clinical trials and technical aspects. [2018]
The Effect of OnabotulinumtoxinA on Aura Frequency and Severity in Patients With Hemiplegic Migraine: Case Series of 11 Patients. [2019]
OnabotulinumtoxinA in chronic migraine: predictors of response. A prospective multicentre descriptive study. [2019]
Sustained onabotulinumtoxinA therapeutic benefits in patients with chronic migraine over 3 years of treatment. [2022]
Long-term study of the efficacy and safety of OnabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. [2018]
Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders. [2018]
A two years open-label prospective study of OnabotulinumtoxinA 195 U in medication overuse headache: a real-world experience. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Bannwarth's syndrome (lymphocytic meningoradiculitis) in Sweden. [2018]
[Erythema chronicum migrans with Bannwarth syndrome (Garin-Bujadoux-Bannwarth meningopolyneuritis)]. [2006]
[Clinical characteristics and perplexities in the treatment of chronic Lyme borreliosis]. [2015]
13.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and Safety of Antibiotic Therapy in Early Cutaneous Lyme Borreliosis: A Network Meta-analysis. [2019]
CXCL13 concentrations in cerebrospinal fluid of patients with Lyme neuroborreliosis and other neurological disorders determined by Luminex and ELISA. [2019]
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