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Study of incobotulinumtoxinA injections for prevention of chronic migraine in adult patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates the use of Xeomin (a type of botulinum toxin A) for people with chronic migraine. Chronic migraine is a condition where a person experiences headaches on 15 or more days per month, with at least 8 of these being migraine headaches, for more than 3 months. The study aims to determine if Xeomin injections are effective in reducing the number of days patients experience migraines compared to placebo.

The study medication will be given through intramuscular injections, meaning the medicine is injected directly into muscles. Participants will receive either Xeomin or placebo injections over a period of 6 months. The treatment involves multiple injection sessions, with the medication being administered at specific intervals throughout the study period.

During the trial, participants will need to keep track of their headaches and migraine days using a headache diary. The study will monitor how the treatment affects the frequency of migraine days, headache days, and the use of other migraine medications. The researchers will also track any side effects that may occur during the treatment period. The total study duration for each participant will be approximately 36 weeks.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The study focuses on evaluating Xeomin® injections for preventing chronic migraine

    Your eligibility will be confirmed based on your migraine history over the past 3 months

    You must have experienced at least 15 headache days per month and at least 8 migraine days per month

  2. Step 2

    Baseline period

    For 28 days before starting treatment, you will need to keep a headache diary

    The diary will help track your headache and migraine days

    You must record at least 15 headache days and 8 migraine days during this period to continue in the study

  3. Step 3

    Treatment phase

    You will receive either Xeomin® (at one of two doses) or a placebo through muscle injections

    The treatment will be given in cycles over 24 weeks (6 months)

    Neither you nor your doctor will know which treatment you are receiving

  4. Step 4

    Monitoring period

    You will continue keeping a headache diary throughout the study

    The main assessment will occur at Month 6 (weeks 21-24 after first injection)

    Your migraine days, headache days, and use of acute migraine medications will be tracked

    Any side effects related to the treatment will be monitored

  5. Step 5

    Final evaluation

    The study will evaluate changes in your monthly migraine days compared to the baseline period

    The effectiveness of the treatment will be measured by a reduction in migraine frequency

    Success will be determined if you experience at least a 50% reduction in monthly migraine days

Who can join the trial?

7 criteria

  • Must be at least 18 years old when signing the consent form
  • Must have been diagnosed with chronic migraine (with or without aura) for at least 12 months and be able to tell the difference between migraine headaches and other types of headaches
  • Must have first experienced migraines before the age of 50 years old
  • Must have experienced in each of the last 3 months:
    • At least 15 headache days per month
    • At least 8 migraine days per month
    • During the last 28 days of the screening period, must have:
      • At least 15 headache days
      • At least 8 migraine days recorded in the headache diary

Who cannot join the trial?

13 criteria

  • Age below 18 or above 65 years
  • Pregnant or breastfeeding women
  • History of botulinum toxin (a protein that can temporarily reduce muscle activity) treatment in the past 6 months
  • Known allergies or hypersensitivity to botulinum toxin or any components of the study medication
  • Current use of medications that could interact with botulinum toxin
  • Presence of any neuromuscular junction disorders (conditions affecting nerve and muscle connections)
  • Active infection at potential injection sites
  • History of facial surgery that could affect the study results
  • Participation in another clinical trial within the past 30 days
  • Any medical condition that could interfere with the evaluation of the study medication
  • Unable to follow study procedures or attend scheduled visits
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could affect the ability to provide informed consent
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Investigated drugs

Xeomin is a type of botulinum toxin medication that is injected into specific areas. It works by temporarily blocking nerve signals that cause muscle contractions. In this trial, it is being studied for preventing chronic migraine headaches. The medication is injected into various points around the head and neck area to help reduce the frequency and severity of migraine headaches. This treatment is typically administered by a healthcare professional in a medical setting.

What is already known about the treatment

Xeomin - A prescription medication administered through targeted intramuscular injections, containing botulinum toxin type A as its active ingredient. This neurotoxin works by temporarily blocking nerve signals that trigger muscle contractions and pain pathways, making it effective in preventing chronic migraine headaches. Xeomin belongs to the pharmacological class of neuromuscular blocking agents and has gained significant recognition in medical literature for its therapeutic use in various neurological conditions. The medication's precise mechanism of action involves inhibiting the release of acetylcholine at nerve endings, which helps reduce muscle tension and neurogenic inflammation associated with chronic migraines.

Investigated diseases

Chronic Migraine - A neurological condition characterized by headaches occurring on 15 or more days per month for more than three months, with at least eight of these headaches being migraines. The pain typically affects one or both sides of the head and is often accompanied by nausea, sensitivity to light and sound, and visual disturbances. Episodes can last from several hours to days, significantly impacting daily activities. The condition tends to develop gradually, often evolving from episodic migraines. Patients may experience varying intensity of symptoms, with some days having more severe headaches than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515682-34-00Protocol codeM602011084Estimated enrolment780 patientsSponsorMerz Therapeutics GmbH

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