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Study on Botulinum Toxin Type A for Preventing Chronic 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 prevention of chronic migraine in adults. Chronic migraine is a condition characterized by frequent and severe headache episodes. The treatment being tested in this study is called Dysport, which contains an active ingredient known as Botulinum Toxin Type A. This substance is commonly used in various medical treatments and is administered as an injection.

The purpose of the study is to evaluate how effective and safe Dysport is in reducing the number of migraine days each month for those who suffer from chronic migraines. Participants in the study will receive either Dysport or a placebo, which is a substance with no active medication. The study will follow participants over a period of time to observe changes in their migraine patterns and any side effects they may experience.

Throughout the study, participants will receive regular injections and will be monitored for any changes in their migraine frequency and severity. The study aims to provide valuable information on whether Dysport can help reduce the burden of chronic migraines and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 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 sign informed consent and privacy documentation.

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

  2. Step 2

    Randomization and initial assessment

    Participants are randomly assigned to receive either Dysport or a placebo.

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

  3. Step 3

    Treatment phase

    Participants receive injections of either Botulinum Toxin Type A (300 or 500 units) or a placebo.

    Injections are administered as a solution for injection at specified intervals.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for changes in MMD and MHD every four weeks, from Week 4 to Week 24.

    Additional assessments include the use of acute migraine medication and any treatment-emergent adverse events.

  5. Step 5

    Evaluation of outcomes

    Primary and secondary outcomes are evaluated, including changes in MMD and MHD, and the impact on quality of life.

    The study aims to determine the efficacy of Dysport in reducing migraine days compared to placebo.

  6. Step 6

    Extension phase

    Participants may enter an extension phase to further evaluate the long-term effects and safety of the treatment.

    Continued monitoring and assessments are conducted during this phase.

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 has been diagnosed with chronic migraine for more than 12 months before the screening visit. Chronic migraine is a type of headache disorder.
  • The participant's migraines started before they were 50 years old.
  • Participant has at least 15 headache days per month and at least 8 migraine days per month, based on data collected using an electronic diary during the 4 weeks before the start of the study.
  • Participant has at least 22 valid diary days recorded during the 4 weeks before the start of the study.

Who cannot join the trial?

4 criteria

  • Participants who do not have chronic migraine. Chronic migraine means having headaches on 15 or more days each month, with at least 8 of those days being migraines.
  • Participants who are not adults. This study is for adults only.
  • Participants who are not within the specified age range for the study.
  • Participants who are part of a vulnerable population. This means people who might need special protection or care.
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Investigated drugs

Dysport is a medication used in this clinical trial to help prevent chronic 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 how well it works compared to not receiving any active treatment.

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 chronic migraines. The main therapeutic indication for Dysport in this context is the reduction of monthly migraine days in adults. At the molecular level, Dysport works by blocking the release of certain neurotransmitters that are involved in muscle contraction, which can help alleviate migraine symptoms. It is classified pharmacologically as a botulinum toxin type A product.

Investigated diseases

Chronic Migraine – Chronic migraine is a neurological condition characterized by experiencing headaches on 15 or more days per month, with at least 8 of those days involving migraines. These migraines are often accompanied by symptoms such as nausea, vomiting, and sensitivity to light or sound. The condition can significantly impact daily life, leading to difficulties in work, social activities, and overall quality of life. Over time, the frequency and severity of migraine attacks may increase, making management challenging. Chronic migraine can develop from episodic migraines, where the frequency of attacks gradually rises. The exact cause of chronic migraine is not fully understood, but it is believed to involve a combination of genetic, environmental, and neurological factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504827-17-00Protocol codeCLIN-52120-463Estimated enrolment1 227 patientsSponsorIpsen Innovation

sourced from the EU Clinical Trials Register and site verification

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