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Study on Botulinum Toxin Type A for Preventing Episodic Migraine in Adults

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What is this trial about?

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

This clinical trial is focused on studying the effectiveness and safety of a treatment called Dysport for preventing episodic migraine in adults. Episodic migraine is a type of headache that occurs less frequently than chronic migraine but can still significantly impact daily life. The treatment being tested is a form of Botulinum Toxin Type A, which is commonly used in various medical and cosmetic procedures. In this study, participants will receive either the Dysport treatment or a placebo, which is an inactive substance, to compare the effects.

The purpose of the study is to evaluate how well Dysport can reduce the number of migraine days each month for those who experience episodic migraines. Participants will be randomly assigned to receive either the Dysport treatment or the placebo. The study will be conducted over several months, with regular check-ins to monitor the number of migraine days and any changes in symptoms. Participants will also be asked to keep a diary of their migraine occurrences and any medications they take for acute migraine relief.

Throughout the study, the safety of the treatment will be closely monitored, and any side effects will be recorded. The study aims to provide valuable information on whether Dysport can be an effective option for reducing the frequency of migraines in adults who suffer from episodic migraines. The results will help determine if Dysport can improve the quality of life for individuals affected by this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is required to provide informed consent and complete privacy and data protection documentation.

    Eligibility is confirmed based on criteria such as age, migraine diagnosis, and baseline headache and migraine days.

  2. Step 2

    Randomization and initial assessment

    Participants are randomly assigned to receive either the Botulinum Toxin Type A or a placebo.

    Initial assessments are conducted to establish baseline data, including the number of monthly migraine days (MMD) and headache days (MHD).

  3. Step 3

    Treatment phase

    Participants receive Botulinum Toxin Type A via intramuscular injection. The dosage is either 500 units or 300 units, depending on the group assignment.

    Injections are administered at specified intervals throughout the study period.

  4. Step 4

    Monitoring and data collection

    Participants are required to maintain an electronic diary (eDiary) to record daily headache and migraine occurrences.

    Data is collected every 4 weeks to monitor changes in MMD and MHD, as well as the use of acute migraine medication.

  5. Step 5

    Evaluation of effectiveness and safety

    The primary goal is to assess the change in monthly migraine days from baseline over a 24-week period.

    Secondary evaluations include the reduction in migraine days by 50% or 75%, changes in headache intensity, and the impact on quality of life.

  6. Step 6

    Extension phase

    Participants may enter an extension phase to continue receiving treatment and monitoring.

    Further assessments are conducted to evaluate long-term effectiveness and safety.

  7. Step 7

    Completion and final assessment

    Upon completion of the study, a final assessment is conducted to evaluate overall outcomes.

    Participants are monitored for any treatment-emergent adverse events and changes in vital signs or laboratory parameters.

Who can join the trial?

5 criteria

  • Participant must be at least 18 years old at the time of signing the informed consent and privacy/data protection documents.
  • Participant must have been diagnosed with migraine for more than 12 months before the screening visit. This includes migraines with aura (visual or sensory disturbances) or without aura, based on the International Classification of Headache Disorders.
  • The participant's migraines must have started before they turned 50 years old.
  • Participant must have fewer than 15 headache days per month and at least 6 migraine days per month, based on data collected using an electronic diary during the 4 weeks closest to the start of the study.
  • Participant must have at least 22 valid diary days recorded during the 4 weeks closest to the start of the study.

Who cannot join the trial?

8 criteria

  • Having any other type of headache disorder besides episodic migraine. Episodic migraine means having migraine headaches on some days, but not every day.
  • Using certain medications that might interfere with the study. This includes drugs that affect the nervous system or those used to prevent migraines.
  • Having a history of certain medical conditions that could affect the study results, such as severe heart problems or uncontrolled high blood pressure.
  • Being pregnant or planning to become pregnant during the study period.
  • Having a known allergy or sensitivity to the study medication or similar products.
  • Participating in another clinical trial at the same time.
  • Having a history of drug or alcohol abuse within the past year.
  • Being unable to comply with the study requirements, such as attending scheduled visits or following study instructions.
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Investigated drugs

Dysport is a medication used in this clinical trial to help prevent episodic migraines in adults. It is being tested to see how effective it is in reducing the number of migraine days each month. Dysport is administered to participants to assess its safety and efficacy compared to a placebo.

What is already known about the treatment

Dysport – Dysport is administered through injections, typically given by a healthcare professional. It is currently being studied in clinical trials for its effectiveness in preventing episodic migraines in adults. The main therapeutic indication for Dysport in this context is the reduction of monthly migraine days. At the molecular level, Dysport works by blocking the release of certain chemicals in the nervous system that are involved in muscle contraction, which may help in reducing migraine frequency. It is classified pharmacologically as a botulinum toxin type A product.

Investigated diseases

Episodic Migraine – Episodic migraine is a type of headache disorder characterized by recurrent headaches that occur less frequently than chronic migraines. These headaches are typically moderate to severe in intensity and can last from a few hours to several days. They are often accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. The frequency of these headaches can vary, but they generally occur on fewer than 15 days per month. The progression of episodic migraines can sometimes lead to an increase in frequency, potentially developing into chronic migraines if not managed effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504839-40-00Protocol codeCLIN-52120-464Estimated enrolment1 227 patientsSponsorIpsen Innovation

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