Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Lu AG09222 for Preventing Migraines in Adults Unresponsive to Previous Treatments

Fast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 migraine, a common type of headache that can cause severe pain, nausea, and sensitivity to light and sound. The study will test a new treatment called Lu AG09222, which is given as a solution for injection. Participants in the trial will receive either the new treatment or a placebo, which is a substance with no active medication, to compare the effects.

The purpose of the study is to evaluate how effective Lu AG09222 is in preventing migraines in adults who have not found relief from previous preventive treatments. The study will involve participants with both episodic and chronic forms of migraine. During the trial, participants will be randomly assigned to different groups, and neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This approach helps ensure that the results are unbiased.

Participants will be monitored over a period of time to track changes in their migraine frequency and severity. The study will also assess the safety of Lu AG09222 by checking for any side effects and changes in health indicators such as vital signs and laboratory test results. The trial aims to provide valuable information on whether this new treatment can offer a new option for people suffering from migraines.

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

    Joining the study

    Upon joining the study, the participant is confirmed to have a diagnosis of migraine as defined by specific guidelines. This includes either migraine without aura, migraine with typical aura, or chronic migraine.

    The participant must have experienced migraines for at least 12 months before joining the study and must be between 18 and 65 years old.

  2. Step 2

    Screening period

    During the first 28 days, the participant uses an electronic diary (eDiary) to record migraine occurrences. This helps confirm the frequency of migraines and headaches.

    For episodic migraine, migraines should occur on at least 4 days, and headaches on less than 15 days. For chronic migraine, migraines should occur on at least 8 days, and headaches on 15 to 26 days.

  3. Step 3

    Treatment phase

    The participant receives either the investigational medication Lu AG09222 or a placebo. The medication is administered as a solution for injection under the skin (subcutaneous).

    The trial is designed to find the appropriate dose for preventing migraines in those who have not been helped by previous treatments.

  4. Step 4

    Monitoring and evaluation

    The participant continues to use the eDiary to track migraines and headaches over a 12-week period.

    The primary goal is to observe changes in the frequency of migraines from the start of the study. Secondary goals include assessing the response to the medication and monitoring any side effects.

  5. Step 5

    Completion of the study

    The study is expected to conclude by June 30, 2026. The participant's data will contribute to understanding the effectiveness and safety of Lu AG09222 for migraine prevention.

Who can join the trial?

15 criteria

  • The participant must have a diagnosis of migraine as defined by specific guidelines, confirmed at the Screening Visit.
  • The participant must have had migraines starting at least 12 months before the Screening Visit.
  • The participant must have started having migraines at or before the age of 50.
  • The participant must have experienced at least 4 migraine days per month for each of the past 3 months before the Screening Visit.
  • The participant must meet specific criteria for EM (Episodic Migraine) or CM (Chronic Migraine) based on information collected in an electronic diary during the first 28 days of the Screening Period:
    • For EM: migraines on at least 4 days and headaches on less than 15 days.
    • For CM: migraines on at least 8 days and headaches on 15 to 26 days.
    • The participant must have used the electronic diary to enter data for at least 24 out of the 28 days following the Screening Visit.
    • The participant must have had treatment failure in the past 10 years with at least 2 to 4 different migraine preventive medications, with at least one failure due to inadequate effectiveness. These medications include:
      • Propranolol or Metoprolol
      • Topiramate
      • Amitriptyline
      • Flunarizine or Lomerizine
      • Candesartan
      • Valproate or Divalproex
      • Botulinum toxin (if used for Chronic Migraine)
      • The participant must be between 18 and 65 years old at the Screening Visit.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of headache that is not a migraine cannot participate. A migraine is a type of headache that often comes with nausea and sensitivity to light and sound.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who have any other medical conditions that might interfere with the study cannot participate. This is to ensure the safety and accuracy of the study results.
  • Patients who are currently taking medications that might affect the study cannot participate. This is to prevent any interference with the study's findings.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Lu AG09222 is a medication being studied for its potential to prevent migraines. It is being tested in a clinical trial to see how well it works for people who experience both episodic and chronic migraines. The trial aims to find the right dose that can effectively reduce the frequency and severity of migraine attacks.

What is already known about the treatment

Lu AG09222 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in preventing migraines. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for Lu AG09222 is the prevention of both episodic and chronic migraines. At the molecular level, it works by targeting specific pathways involved in migraine development, potentially reducing the frequency and severity of migraine attacks. It is classified pharmacologically as a migraine prevention agent.

Investigated diseases

Migraine – A migraine is a type of headache characterized by intense, throbbing pain, usually on one side of the head. It often comes with other symptoms like nausea, vomiting, and sensitivity to light and sound. Migraines can last for hours or even days and may be preceded by warning symptoms known as an aura, which can include visual disturbances or tingling sensations. The frequency and severity of migraines can vary widely among individuals. Some people experience migraines occasionally, while others may have them frequently, impacting daily activities. The exact cause of migraines is not fully understood, but they are believed to involve changes in brain chemicals and nerve pathways.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508821-28-00Protocol code20297AEstimated enrolment1 036 patientsSponsorH. Lundbeck A/S

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.