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Study on Long-term Safety and Tolerability of Atogepant for Children and Teens (Ages 6-17) with Migraine

Verified siteInvestigationalNo placebo
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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 long-term safety and tolerability of a medication called Atogepant in children and teenagers aged 6 to 17 who experience Migraine. Migraines are severe headaches that can cause intense throbbing or pulsing in one area of the head, often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. The purpose of this study is to understand how safe and tolerable Atogepant is when used over a long period to prevent migraines in young people.

Participants in the study will take Atogepant in the form of a tablet, which is taken orally. The study will monitor participants for any side effects or adverse events, which are unexpected medical problems that occur during treatment. This includes regular checks on their health through laboratory tests, heart monitoring using an Electrocardiogram (ECG), and assessments of vital signs like blood pressure and heart rate. The study will also look at any changes in mood or behavior, especially any thoughts of self-harm, using a tool called the Columbia-Suicide Severity Rating Scale.

The study is designed to last for a significant period, allowing researchers to gather comprehensive data on the long-term effects of Atogepant. Participants will be closely monitored throughout the study to ensure their safety and well-being. This research aims to provide valuable insights into the use of Atogepant for preventing migraines in children and teenagers, potentially offering a new option for managing this challenging 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

    Initial visit

    Upon joining the study, you will have an initial visit. During this visit, your eligibility will be confirmed based on your age, weight, and migraine history.

    You will be asked about your medical history and any previous participation in related studies.

  2. Step 2

    Medication administration

    You will begin taking the medication atogepant in the form of a tablet. This medication is taken orally.

    The dosage and frequency will be determined by the study team and will be explained to you during the initial visit.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication.

    These check-ups will include assessments such as blood tests, heart monitoring (ECG), and vital sign measurements.

  4. Step 4

    Adverse event monitoring

    You will be monitored for any adverse events, which are unexpected medical issues that may occur during the study.

    If you experience any adverse events, you should report them to the study team immediately.

  5. Step 5

    Behavioral assessments

    You will undergo behavioral assessments to evaluate any changes in your behavior or mood.

    These assessments will include tools like the Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF2).

  6. Step 6

    Menstrual cycle assessments

    If applicable, menstrual cycle assessments will be conducted to monitor any changes related to the medication.

  7. Step 7

    Study completion

    The study is expected to continue until November 2029. Upon completion, you will have a final visit to assess your overall health and any long-term effects of the medication.

Who can join the trial?

5 criteria

  • Participants must be between 6 and 17 years of age (inclusive).
  • Participants must have a history of episodic or chronic migraine. Episodic migraine means having migraine attacks on some days, while chronic migraine means having them on many days each month.
  • Participants must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712. Pharmacokinetic refers to how the body absorbs, distributes, and gets rid of a drug.
  • Participants must weigh at least 20 kg (44 lbs) and less than 135 kg (298 lbs).
  • Participants must have a history of migraine with or without aura for at least 6 months. Aura refers to visual or sensory disturbances that can occur before a migraine attack.

Who cannot join the trial?

9 criteria

  • Participants who are not between the ages of 6 and 17 years old.
  • Participants who do not have a diagnosis of migraine.
  • Participants who are unable to comply with the study procedures.
  • Participants who have any other medical condition that the study doctors think might make it unsafe for them to participate.
  • Participants who are currently taking part in another clinical trial.
  • Participants who have a history of allergic reactions to the study medication or similar medications.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a history of drug or alcohol abuse.
  • Participants who have a significant psychiatric disorder that is not well controlled.
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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 pain, nausea, and sensitivity to light and sound. Atogepant works by blocking certain signals in the brain that are thought to contribute to migraines. This study aims to see if atogepant is safe and well-tolerated when used over a long period. Participants in the trial will take atogepant regularly to help reduce the frequency and severity of their migraine attacks.

What is already known about the treatment

Atogepant – Atogepant is administered orally in the form of tablets and is currently being studied for its long-term safety and tolerability in children and teenagers aged 6 to 17 who suffer from migraines. It is not yet widely used in medicine, as it is still under investigation in clinical trials. The main therapeutic use of atogepant is to prevent migraines, which are severe headaches often accompanied by nausea and sensitivity to light and sound. At the molecular level, atogepant works by blocking a specific receptor in the brain that is involved in the development of migraines, helping to reduce their frequency and severity. It is classified as a calcitonin gene-related peptide (CGRP) receptor antagonist, a type of medication that targets the pathways involved in migraine attacks.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last for hours to days and may vary in frequency and intensity. Some individuals experience warning symptoms known as aura, which can include visual disturbances or tingling sensations. The progression of migraine can involve different phases, including the prodrome, aura, headache, and postdrome phases. Over time, migraines can become more frequent or severe, affecting daily activities and quality of life.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501099-24-00Protocol codeM21-199Estimated enrolment586 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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