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Study on Long-Term Safety of Atogepant for Preventing Migraine in Patients with Chronic or Episodic 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 prevention of migraine, a condition characterized by severe headaches that can be accompanied by symptoms like nausea and sensitivity to light. The study includes participants who experience either chronic migraine or episodic migraine. Chronic migraine involves headaches on 15 or more days per month, while episodic migraine occurs less frequently. The treatment being tested is a medication called Atogepant, which is taken orally in the form of a tablet.

The purpose of this study is to evaluate the long-term safety and tolerability of Atogepant when used over a period of 156 weeks. Participants will take a 60 mg dose of Atogepant once daily. The study is designed to observe how well participants tolerate the medication over this extended period and to monitor any side effects that may arise. This is an open-label study, meaning that both the researchers and participants know which treatment is being administered.

Throughout the study, participants will be regularly monitored for any adverse events, which are any unwanted effects that occur during the trial. The study will also assess any significant changes in laboratory test results, heart function as measured by electrocardiograms (ECGs), and vital signs such as blood pressure and heart rate. The goal is to ensure that Atogepant is safe for long-term use in preventing migraines in those who suffer from this condition.

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, you will be informed about the purpose and procedures involved. This study aims to evaluate the long-term safety and tolerability of the medication atogepant for preventing migraines.

    You will be required to have completed specific visits from previous related studies without significant issues or adverse events.

  2. Step 2

    Medication administration

    You will take an oral tablet of atogepant at a dose of 60 mg once daily. This medication is intended to help prevent migraines.

    The duration of this medication administration is planned for up to 156 weeks.

  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 of laboratory values, electrocardiograms (ECGs), and vital signs to ensure your safety.

  4. Step 4

    Reporting side effects

    You are encouraged to report any side effects or unusual symptoms you experience during the study.

    The primary focus is on identifying any treatment-emergent adverse events, which are side effects that occur after starting the medication.

  5. Step 5

    Completion of the study

    The study is expected to conclude by October 2025. Upon completion, your participation will help in understanding the long-term safety of atogepant for migraine prevention.

    Your contribution is valuable in assessing the medication's effects over an extended period.

Who can join the trial?

5 criteria

  • You must have completed Visit 7, and Visit 8 if needed, of Study 3101-303-002 or Study 3101-304-002 without any major issues following the study rules.
  • You must not have had any serious side effects that could mean the treatment is not safe for you.
  • You must be diagnosed with Chronic or Episodic Migraine. This includes migraines with or without aura, or chronic migraines. An aura is a visual or sensory disturbance that can happen before a migraine.
  • Both men and women can participate in the study.
  • The study includes people who might be considered part of a vulnerable population. This means groups of people who might need special protection or care.

Who cannot join the trial?

9 criteria

  • Participants cannot join if they have any other serious health conditions that might interfere with the study.
  • Individuals who are currently participating in another clinical trial are not eligible.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Participants who have had a recent surgery or plan to have surgery during the study period are excluded.
  • People with a history of drug or alcohol abuse in the past year are not allowed to participate.
  • Individuals who have an allergy or sensitivity to the study medication or similar drugs cannot join.
  • Participants who are unable to comply with the study procedures or follow-up visits are not eligible.
  • Anyone with a history of certain mental health disorders that are not well controlled is excluded.
  • Individuals who have used certain medications that might interfere with the study drug within a specified time frame before the study starts are not eligible.
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Investigated drugs

Atogepant is a medication being studied for its ability to prevent migraines. It is taken by mouth and works by blocking a specific protein in the brain that is involved in the development of migraines. This study is looking at how safe and well-tolerated atogepant is when used over a long period, specifically for people who experience chronic or episodic migraines. The goal is to see if it can help reduce the frequency and severity of migraine attacks over time.

What is already known about the treatment

Atogepant – Atogepant is an oral medication taken once daily, designed to prevent migraines in people who experience them either chronically or episodically. It is currently being studied in a long-term clinical trial to assess its safety and tolerability over a period of 156 weeks. Atogepant works by blocking a specific receptor in the brain that is involved in the development of migraines, helping to reduce their frequency. It belongs to a class of drugs known as CGRP receptor antagonists, which are used to prevent migraine attacks.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. It can occur with or without aura, which are sensory disturbances that can include visual changes or tingling sensations. Migraine attacks can last from a few hours to several days and may vary in frequency from episodic to chronic. Chronic migraine is defined as having headaches on 15 or more days per month for more than three months, with migraine features on at least eight of those days. The progression of migraine can involve an increase in the frequency and severity of attacks over time. Factors such as stress, hormonal changes, and certain foods or drinks can trigger or worsen migraine episodes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507096-21-00Protocol code3101-312-002Estimated enrolment596 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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