Xeomin Injections for Migraine

(MINT-C Trial)

Recruiting at 56 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 antibodies

Disqualifiers: Other primary headaches, Secondary 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: 6

Duration: 48 weeks

780 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Xeomin injections might reduce migraines in individuals with chronic migraine headaches. Participants will receive either Xeomin (a type of botulinum toxin injection) or a placebo injection into the head and neck muscles to assess changes in the number of migraine days each month. The trial spans about a year, with visits occurring mostly every four weeks. Individuals who have experienced chronic migraines (headaches lasting 15 or more days per month) for at least a year and can distinguish their migraines from other headaches might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking migraine treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot be taking more than one prescribed drug for migraine prevention. If you recently stopped a specific migraine treatment (anti-CGRP), it must have been at least 5 months ago.

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

Research has shown that Xeomin has been tested for various uses, such as treating muscle issues and reducing wrinkles. Studies indicate it is generally safe, though some side effects can occur. After receiving Xeomin injections, some individuals might experience muscle weakness, blurred vision, or drooping eyelids. These side effects may appear within hours to weeks after treatment.

The FDA has already approved Xeomin for other uses, indicating its safety is well-documented. However, serious side effects can occur, such as the toxin spreading to other areas, causing symptoms like trouble swallowing or breathing.

In preclinical tests, Xeomin did not show unexpected risks to people, meaning it didn't cause harm in those early studies. Overall, while Xeomin is usually well-tolerated, it's important to consider these possible risks when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Xeomin injections for migraines because, unlike traditional treatments like oral medications and Botox, Xeomin is a uniquely purified form of botulinum toxin type A. This purification process removes accessory proteins that aren't needed for treatment, potentially reducing the risk of immune responses and increasing effectiveness over time. By targeting pericranial and cervical points, Xeomin aims to disrupt pain pathways more precisely, offering migraine relief with potentially fewer side effects.

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

Research has shown that Xeomin injections can reduce the frequency of migraines. One study found that 73% of patients experienced a reduction in migraine episodes by more than half after receiving Xeomin. Another study reported that most patients had fewer and less severe headaches, with benefits lasting about 82 days on average. This trial will test different doses of Xeomin, with some participants receiving Xeomin Dose A and others receiving Xeomin Dose B. Other findings suggest that increasing the dose of similar treatments can reduce headache days by about two days each month. These results offer hope that Xeomin could greatly benefit those with chronic migraines. ^{4 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 with chronic migraine. Participants will be involved in the study for about a year, need to attend on-site visits for initial and final assessments as well as treatments, and agree to remote check-ins.

Inclusion Criteria

I've had over 15 headache days and at least 8 were migraines in the last month.

I've had at least 15 headache days and 8 migraine days each month for the last 3 months.

I have been diagnosed with chronic migraine for over a year and can tell it apart from other headaches.

Exclusion Criteria

I have been diagnosed with a headache type, but it's not tension-type.

I am currently taking more than one medication to prevent migraines.

I stopped my anti-CGRP treatment less than 5 months ago.

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

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

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person), 1 visit (remote)

Extension

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

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Xeomin

Trial Overview The trial is testing Xeomin injections against a placebo to see if they can reduce the number of migraine days each month. Patients receive four treatments over the course of a year with follow-up 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/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 ...

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. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-022-02742-x

OnabotulinumtoxinA in chronic migraine: is the response dose ... Interestingly, our results showed that increase in the onabotulinumtoxinA dose improves the number of headache days by around 2 days. This value ...

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/2018/125360s073lbl.pdf

Xeomin - accessdata.fda.gov XEOMIN is contraindicated in the presence of infection at the proposed injection site(s). 5. WARNINGS AND PRECAUTIONS. 5.1 Spread of Toxin Effect. Postmarketing ...

7. xeominaesthetic.com xeominaesthetic.com/wp-content/uploads/2025/10/xeomin-pi-med-guide.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION The safety profile of XEOMIN during the open-label extension period was similar to that observed in the double-blind phase of the placebo-controlled pediatric ...

8. xeomin.com xeomin.com/?m

XEOMIN may cause serious side effects that can be life ... XEOMIN may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking XEOMIN.

9. medsafe.govt.nz medsafe.govt.nz/profs/Datasheet/x/Xeomininj.pdf

Xeomin (powder for injection) Non-clinical data revealed no special hazard for humans based on conventional studies of cardiovascular safety pharmacology. The findings from repeat-dose ...