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Study of IncobotulinumtoxinA injections compared to placebo for prevention of episodic migraine attacks

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What is this trial about?

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

This clinical trial studies the effectiveness of Xeomin injections in preventing episodic migraine. Episodic migraine is a condition where a person experiences headaches with specific features, occurring between 6 to 14 days per month. The study uses Clostridium Botulinum neurotoxin type A, also known as incobotulinumtoxinA, which is administered through intramuscular injection.

The main purpose of this research is to determine if Xeomin is more effective than placebo in reducing the number of monthly migraine days. The study involves different doses of the medication, with participants receiving either Xeomin or placebo injections. The treatment period lasts for 6 months, during which participants will receive multiple injections.

The medication being tested, Xeomin, is a purified form of botulinum toxin that is free from complexing proteins. The study will monitor how the treatment affects the frequency of migraine days, headache days, and the use of acute migraine medications. Throughout the study, participants will need to keep track of their migraine episodes and any changes in their condition.

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 trial evaluates Xeomin® injections for preventing episodic migraine

    You will need to confirm having 6-14 migraine days per month for the past 3 months

    You will need to keep a headache diary for 28 days before starting treatment

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either Xeomin® or a placebo (inactive substance)

    Neither you nor your doctor will know which treatment you receive

    The medication will be given through intramuscular injections (into the muscle)

  3. Step 3

    Treatment period

    The main study period lasts 6 months

    You will receive multiple treatment cycles

    You will need to continue keeping your headache diary throughout the study

    Your migraine days will be monitored every two weeks during weeks 11-12 of each treatment cycle

  4. Step 4

    Final evaluation

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

    Changes in your monthly migraine days will be compared to your starting point

    The number of days you needed migraine medication will be evaluated

    Any side effects that occurred during treatment will be assessed

  5. Step 5

    Extension period

    After the main study period, there will be an extension period

    The total study duration may continue until June 2028

    Your participation will be monitored for safety throughout the entire study period

Who can join the trial?

7 criteria

  • Must be at least 18 years old when signing the consent form
  • Must have been diagnosed with episodic migraine (with or without aura) for 12 months or longer and be able to tell the difference between migraine headaches and other types of headaches
  • Must have had first migraine symptoms before age 50
  • In the 3 months before screening, must have:
    • No more than 14 headache days per month
    • Between 6 to 14 migraine days per month
    • During the last 28 days of screening period, must have:
      • No more than 14 headache days
      • Between 6 to 14 migraine days

Who cannot join the trial?

14 criteria

  • History of chronic migraine (15 or more headache days per month)
  • Current use of preventive migraine medications (drugs taken regularly to reduce frequency of migraines)
  • Previous treatment with botulinum toxin in the past 6 months
  • Presence of other types of headaches that could interfere with the assessment of migraines
  • Pregnancy or breastfeeding
  • Known allergic reactions to botulinum toxin products
  • Active neurological conditions (diseases affecting brain, nerves, or spinal cord)
  • History of neuromuscular junction disorders (conditions affecting nerve-muscle connections)
  • Use of medications that could interact with the study treatment
  • Participation in another clinical trial within the past 30 days
  • Presence of severe psychiatric disorders (mental health conditions requiring ongoing treatment)
  • Uncontrolled medical conditions that could affect study participation
  • History of substance abuse within the past year
  • Inability to follow study procedures or attend scheduled visits
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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 migraine prevention, it helps reduce the frequency and severity of headaches by relaxing muscles and potentially blocking pain signals. The treatment involves a series of small injections in specific points around the head and neck area. This medication is already approved for various medical conditions, including chronic migraine, and is now being studied for episodic migraine prevention.

What is already known about the treatment

Xeomin - A prescription medication administered through injections, containing botulinum toxin type A as its active ingredient. This neurotoxin-based medication works by blocking nerve signals that cause muscle contractions, effectively reducing muscle activity in targeted areas. Currently approved for various medical conditions, it is being studied in clinical trials for the prevention of episodic migraine, where it may help reduce the frequency of migraine attacks by targeting specific muscle groups and nerve endings involved in migraine pathways. As a neuromuscular blocking agent, it belongs to the pharmacological class of neurotoxins used therapeutically, and its effects typically last several months before requiring repeat treatment.

Investigated diseases

Episodic Migraine - A neurological condition characterized by recurring headache attacks that occur between 4 and 14 days per month. These headaches typically cause moderate to severe throbbing pain, often on one side of the head, and can last from 4 to 72 hours if untreated. During migraine episodes, patients commonly experience sensitivity to light, sound, and movement, and may also have nausea or vomiting. Between migraine attacks, patients typically return to their normal state without headache symptoms. The condition tends to run in families and can be influenced by various environmental and hormonal triggers.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515715-22-00Protocol codeM602011085Estimated enrolment990 patientsSponsorMerz Therapeutics GmbH

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