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Study on Atogepant for Treating Migraine in Patients: Evaluating Effectiveness and Safety

Fast replyInvestigationalNo 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 effects of a medication called Atogepant for the treatment of Migraine. Migraines are severe headaches that can cause intense throbbing or pulsing in one area of the head and are often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. The study will compare the effectiveness of Atogepant, which is taken as a tablet, to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how well Atogepant works in treating a single migraine attack. Participants will be randomly assigned to receive either Atogepant or a placebo. 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 initial phase. This helps ensure that the results are not influenced by expectations about the treatment. After this phase, there will be an "open-label extension," where all participants will have the opportunity to receive Atogepant.

Throughout the study, participants will take the medication when they experience a migraine attack and will be monitored for their response to the treatment. The study will assess various outcomes, such as the relief of headache pain and the ability to return to normal activities. The trial aims to provide valuable information about the safety and effectiveness of Atogepant for people who suffer 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

    Randomization

    Upon joining the study, you will be randomly assigned to receive either the atogepant tablet or a placebo. This process is double-blind, meaning neither you nor the researchers will know which one you are receiving.

  2. Step 2

    Treatment period

    During the treatment period, you will take a single dose of the assigned tablet orally when you experience a migraine attack. The tablet is 60 mg, and it is important to take it as soon as the migraine begins.

  3. Step 3

    Monitoring and assessment

    After taking the tablet, your response to the treatment will be monitored. Key assessments include pain relief and the ability to function normally at various time points, such as 2 hours and 8 hours after taking the dose.

    You will be asked to record your symptoms and any side effects in an electronic diary (eDiary). This information helps evaluate the effectiveness and safety of the treatment.

  4. Step 4

    Open-label extension

    Following the initial treatment period, there is an open-label extension phase. In this phase, all participants will receive the atogepant tablet, allowing further evaluation of its long-term effects.

  5. Step 5

    Completion

    The study is expected to conclude by November 23, 2025. Upon completion, the collected data will be analyzed to determine the overall efficacy and safety of atogepant for treating migraine attacks.

Who can join the trial?

13 criteria

  • You must agree to participate by signing a consent form before any study procedures begin.
  • You should have a history of migraines that last between 4 to 72 hours if not treated or if treatment fails, with at least 48 hours of no headache pain between episodes.
  • You should have experienced 2 to 8 migraine attacks per month with moderate to severe pain in each of the 3 months before the first study visit.
  • If you are a female, you must not be pregnant or breastfeeding, and you should not plan to become pregnant or donate eggs during the study and for about 30 days after the last dose of the study drug.
  • If you are a female who can have children, you must have a negative pregnancy test at the first visit and another negative test at the second visit. If the test results are unclear, further testing is required, and you cannot participate if the result is positive.
  • If you are a female who can have children, you must use at least one approved method of birth control from 30 days before the second visit until 30 days after the last dose of the study drug. If you cannot have children, birth control is not needed.
  • You should have used medication, either prescribed or over-the-counter, for treating migraines in the past.
  • If you are taking oral or injectable medications to prevent migraines, the treatment must be stable for at least 3 months before the second visit and should not change during the study.
  • If you are part of the Triptan-Unsuitable substudy, you must meet all the main study criteria and not meet any exclusion criteria. You must also be considered "triptan-unsuitable," meaning you either cannot use triptans due to medical reasons or have tried at least two different triptans without achieving pain relief.
  • You must be able and willing to read, understand, and complete study questionnaires and an electronic diary.
  • You must be between 18 to 75 years old at the first visit and meet the legal age of adulthood according to local laws.
  • You should have a history of migraines, with or without aura, for at least 12 months before the first visit.
  • Your migraines should have started before you turned 50 years old.

Who cannot join the trial?

8 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.
  • Individuals with **serious health conditions** that might interfere with the study results are excluded. Serious health conditions are illnesses that can affect your overall health significantly.
  • Participants who are currently taking other medications that might interact with the study drug are not allowed. Some medications can change how other drugs work in your body.
  • Women who are pregnant or breastfeeding cannot join the study. Pregnancy and breastfeeding involve changes in the body that could affect the study.
  • People who have participated in another clinical trial recently are not eligible. This is to ensure that previous treatments do not affect the study results.
  • Individuals with a history of **substance abuse** are excluded. 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 affect their ability to follow study instructions are not allowed. Mental health conditions can include things like depression or anxiety.
  • Anyone who cannot commit to attending all study visits or follow the study procedures is excluded. This is important to ensure accurate and complete study results.
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Investigated drugs

Atogepant is a medication being studied for its effectiveness in treating migraine attacks. It is taken as a single dose to see how well it can relieve the symptoms of a migraine. The trial aims to determine if atogepant can effectively treat a migraine attack compared to not taking any active medication.

What is already known about the treatment

Atogepant – Atogepant is administered orally and is currently being studied in clinical trials for its effectiveness in treating migraines. It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indication for atogepant is the acute treatment of migraine attacks. At the molecular level, atogepant works by blocking the activity of a protein called calcitonin gene-related peptide (CGRP), which is involved in the development of migraine headaches. It is classified pharmacologically as a CGRP receptor antagonist.

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 from a few hours to several days and may vary in frequency and intensity. Some individuals experience warning symptoms, known as aura, before the onset of a migraine. The exact cause of migraines is not fully understood, but they are believed to involve genetic and environmental factors. Triggers can include stress, certain foods, hormonal changes, and sensory stimuli.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506029-12-00Protocol codeM24-305Estimated enrolment1 785 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).