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Study on the Safety and Effectiveness of Atogepant for Preventing Episodic Migraine in Children and Teens Aged 6 to 17

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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 effects of a medication called Atogepant for the treatment of episodic migraine in children and teenagers aged 6 to 17 years. Episodic migraine is a type of headache that occurs less frequently than chronic migraine, typically with fewer than 15 headache days per month. The study aims to evaluate the safety and effectiveness of two different doses of Atogepant, which is taken in tablet form.

The purpose of the study is to assess how well Atogepant works in reducing the number of migraine days each month over a 12-week period. Participants will be randomly assigned to receive either Atogepant or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the trial.

Throughout the study, participants will take the medication daily and will be monitored for any changes in their migraine symptoms and overall health. The study will also track any side effects that may occur. By the end of the 12-week period, researchers hope to gather valuable information on the potential benefits and safety of Atogepant for young people with episodic migraine.

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, participants will be informed about the purpose and procedures involved in the trial. The study aims to evaluate the safety and effectiveness of two doses of atogepant for treating episodic migraine in children and teenagers aged 6 to 17 years.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes checking weight, which must be between 20 kg (44 lbs) and 135 kg (298 lbs), and reviewing the history of episodic migraine, which should be consistent with a diagnosis for at least 6 months.

  3. Step 3

    Baseline period

    Participants will record their migraine and headache days over a 28-day baseline period using an electronic diary. This helps establish a baseline for comparison during the treatment phase.

  4. Step 4

    Treatment phase

    Participants will be randomly assigned to receive either a low or high dose of atogepant or a placebo. The medication is taken orally in tablet form once daily for 12 weeks.

    The low dose is 10 mg, and the high dose is 60 mg. The placebo tablets are designed to look like the atogepant tablets but do not contain the active ingredient.

  5. Step 5

    Ongoing monitoring

    Throughout the 12-week treatment period, participants will continue to record their migraine and headache days, as well as any use of acute medication, in their electronic diary.

    Regular check-ins with the study team will occur to monitor health and any side effects.

  6. Step 6

    Final assessment

    At the end of the 12-week period, participants will undergo a final assessment. This includes evaluating changes in migraine and headache days, medication use, and quality of life scores.

    The study aims to determine if there is a significant reduction in migraine days and improvement in quality of life.

Who can join the trial?

4 criteria

  • Participant must weigh between 20 kg (44 lbs) and 135 kg (298 lbs).
  • Participant must have a history of episodic migraine for at least 6 months. Episodic migraine means having migraine attacks that occur on some days but not every day.
  • Participant must have had 4 to 14 migraine days and less than 15 headache days in the last 28 days, as recorded in an electronic diary (eDiary).
  • To join a specific part of the study, called the PK substudy, participants must be between 6 to 11 years old and have a history of migraine. The doctor must also agree that preventive treatment for migraine is suitable for them.

Who cannot join the trial?

7 criteria

  • Patients who have a history of **allergic reactions** to the study medication or similar medications cannot participate. An allergic reaction is when your body reacts badly to something, like a rash or trouble breathing.
  • Patients who are currently taking other medications that might interfere with the study medication are not eligible. This means if you are taking certain drugs that could affect how the study drug works, you cannot join.
  • Patients with **serious health conditions** that could affect their safety during the study cannot participate. Serious health conditions are illnesses that can make you very sick or need a lot of medical care.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible. This means if you were part of another study recently, you need to wait before joining this one.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who have a history of **substance abuse** are not eligible. Substance abuse means using drugs or alcohol in a way that is harmful to your health.
  • Patients who have a **mental health condition** that might interfere with their ability to follow study instructions cannot participate. This means if you have a mental illness that makes it hard to understand or remember things, you might not be able to join.
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Investigated drugs

Atogepant is a medication being studied for its ability to prevent migraines in children and teenagers aged 6 to 17. Migraines are severe headaches that can cause intense pain, nausea, and sensitivity to light and sound. Atogepant works by blocking a specific protein in the brain that is involved in the development of migraines. By doing this, it aims to reduce the frequency and severity of migraine attacks, helping young patients experience fewer headaches and improve their quality of life. The study is testing the safety and effectiveness of atogepant when taken daily.

What is already known about the treatment

Atogepant – Atogepant is a medication taken orally, typically in the form of a pill, and is used for the preventive treatment of episodic migraines, particularly in children and teenagers aged 6 to 17. It is currently being studied in clinical trials to assess its safety and effectiveness for this purpose. Atogepant works by blocking certain receptors in the brain that are involved in the development of migraines, helping to reduce the frequency of these headaches. It belongs to a class of drugs known as CGRP receptor antagonists, which are designed to prevent migraines by targeting specific pathways in the brain.

Investigated diseases

Episodic Migraine – Episodic migraine is a neurological condition characterized by recurrent headaches that occur on fewer than 15 days per month. These headaches are often moderate to severe in intensity and can be accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. The progression of episodic migraine involves the occurrence of headache attacks that can last from a few hours to several days. The frequency and severity of these attacks can vary widely among individuals. Over time, some individuals may experience changes in the pattern or frequency of their migraine episodes. The condition is distinct from chronic migraine, which involves headaches on 15 or more days per month.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501100-94-00Protocol codeM21-201Estimated enrolment450 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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