Xeomin for Migraine

(MINT-E Trial)

Recruiting at 55 trial locations

Overseen By Public Disclosure Manager

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merz Therapeutics GmbH

Must not be taking: Anti-CGRP, others

Disqualifiers: Chronic migraine, other primary headaches, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 48 weeks

990 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Xeomin injections can reduce the number of migraine days each month for individuals with episodic migraines. Participants will receive injections in the head and neck with either Xeomin or a placebo to determine which is more effective. The trial lasts one year, including four in-person treatments and follow-up calls. It may suit individuals who have experienced episodic migraines for over a year, with 6 to 14 migraine days per month, and can distinguish their migraines from other headaches. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new migraine treatment to market.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be taking more than one prescribed drug for migraine prevention. If you recently stopped anti-CGRP treatments, it must have been at least 5 months before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Xeomin, a type of botulinum toxin, is generally well-tolerated. Some studies found that side effects from the injection, such as neck pain, are usually mild and temporary, rarely causing people to stop treatment. However, serious side effects, including trouble swallowing, speaking, or breathing, have been reported and can occur within hours to weeks after treatment.

Xeomin is already FDA-approved for other uses, indicating general safety. However, like any treatment, it carries risks, and these should be considered when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Xeomin is unique because it offers a potential new approach to treating migraines by using botulinum toxin type A, similar to Botox, but with a purified formulation that might reduce the risk of developing antibodies. Unlike standard treatments like triptans, which work by narrowing blood vessels to relieve pain, Xeomin targets muscle activity at specific pericranial and cervical points, potentially reducing the frequency and severity of migraines. Researchers are excited about Xeomin because it could provide a longer-lasting and more focused treatment option with fewer side effects compared to existing migraine medications.

What evidence suggests that this trial's treatments could be effective for migraines?

Studies have shown that Xeomin can greatly reduce migraine frequency. In one study, 73% of patients experienced a reduction in migraine frequency by more than half. Another report found that about 81.8% of patients had fewer and less severe headaches after using Xeomin. These findings suggest that Xeomin might effectively manage migraines by reducing headache days. In this trial, participants will receive either Xeomin at different doses or a placebo. Although research is ongoing to confirm these results, the initial data appears promising. ^{3 6 7 8 9}

Who Is on the Research Team?

Merz Medical Expert

Principal Investigator

Merz Therapeutics

Are You a Good Fit for This Trial?

This trial is for individuals who experience episodic migraines. Participants should be available for a year-long study with on-site and remote visits. Specific inclusion and exclusion criteria details are not provided, but typically involve meeting diagnostic criteria for the condition being studied.

Inclusion Criteria

In the last 28 days, I had up to 14 headache days and 6-14 migraine days.

My migraines started before I turned 50.

I have been diagnosed with episodic migraines for over a year and can tell them apart from other headaches.

Exclusion Criteria

I am taking more than one medication to prevent migraines.

I have been diagnosed with chronic migraine.

I have been diagnosed with a type of secondary headache, but medication overuse headache is allowed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 to 5 weeks

1 visit (in-person)

Treatment

Participants receive Xeomin or Placebo injections into muscles of the head and neck, with 4 treatments approximately 12 weeks apart

48 weeks

6 visits (in-person), 8 visits (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Extension

Participants may continue to receive Xeomin injections at pericranial and cervical points

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Xeomin

Trial Overview The trial is testing Xeomin injections versus Placebo to see if Xeomin can reduce the number of migraine days per month. The treatment involves four injection sessions spread over a year, with follow-up visits every four weeks.

How Is the Trial Designed?

Group I: Xeomin Dose B Experimental Treatment 1 Intervention

Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical point (dose B)

Group II: Xeomin Dose A Experimental Treatment 1 Intervention

Placebo-controlled period + extension period: Xeomin injections at pericranial and cervical points (dose A)

Group III: Placebo Placebo Group 2 Interventions

Placebo-controlled period: Placebo injections at pericranial and cervical points. Extension period: Xeomin injections at pericranial and cervical points (dose A)

Who Is Running the Clinical Trial?

Merz Therapeutics GmbH

Lead Sponsor

Trials

4

Recruited

510+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6024863/

Monocentric Prospective Study into the Sustained Effect of ... From baseline to first injection, 44 patients (73%) had >50% reduction in frequency of migraine episodes, 29 patients (48%) showed >50% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07018713

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® ... The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: Trial duration: 52 ...

3. merztherapeutics.com merztherapeutics.com/us/merz-therapeutics-announces-first-patients-enrolled-in-two-phase-iii-trials-investigating-xeomin-incobotulinumtoxina-for-migraine-prevention/

North America (US) Merz Therapeutics Announces First Patients Enrolled in Two Phase III Trials Investigating XEOMIN® (incobotulinumtoxinA) for Migraine Prevention.

4. clinicaltrial.be clinicaltrial.be/en/details/76727?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

BOTOX® vs. XEOMIN® for Chronic Migraine Changes in chronic migraine frequency and duration are recorded and compared. Primary outcomes. 1. Headache days per month. To compare the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291815008516

IncobotulinumtoxinA for Migraine: A Retrospective Case ... Most patients experienced an improvement in headache frequency and/or intensity (81.8%). The duration of action for these patients averaged 81.9 ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/125360s078lbl.pdf

XEOMIN (incobotulinumtoxinA) - accessdata.fda.gov Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established for lower limb spasticity, sialorrhea, cervical dystonia, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07018700

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® ... The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: Trial duration: 52 ...

8. hcp.xeomin.com hcp.xeomin.com/healthcare-professionals/

XEOMIN® Information For HCPs - Dosing, Efficacy & Safety Designed with Purity in mind, XEOMIN contains only the active neurotoxin. Over time, repeated exposure to therapeutic proteins can contribute to a decrease ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5367647/

Botulinum toxin in the management of chronic migraine Injection-related AEs are usually mild and transient and rarely lead to abortion of therapy. Among the reported AEs in the PREEMPT studies, neck pain (4.3%), ...