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Study Comparing Atogepant and Topiramate for Preventive Treatment in Adults with Migraine

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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 effectiveness and safety of two medications, Atogepant and Topiramate, for the preventive treatment of migraine. Migraines are severe headaches that can cause intense throbbing or pulsing sensations, often accompanied by nausea, vomiting, and sensitivity to light and sound. The purpose of the study is to compare how well these medications work and how safe they are for people who need to prevent migraines.

Participants in the study will be randomly assigned to receive either Atogepant, Topiramate, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drugs. The study will last for several weeks, during which participants will take the assigned medication and report any side effects or changes in their migraine symptoms. The study aims to find out if Atogepant is as effective and safe as Topiramate, which is already used for migraine prevention.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their migraine patterns. The study will also include an open-label extension, where all participants may have the opportunity to receive Atogepant to further assess its long-term safety and effectiveness. This trial is an important step in understanding how these medications can help people who suffer from migraines and improve their quality of life.

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, eligibility is confirmed based on a documented history of migraine for at least 12 months and experiencing at least 4 migraine days per month.

  2. Step 2

    Randomization and initial treatment

    Participants are randomly assigned to receive either atogepant or topiramate as preventive treatment for migraines.

    Atogepant is administered orally in tablet form, while topiramate is also administered orally.

  3. Step 3

    Double-blind treatment period

    The double-blind treatment period lasts for 24 weeks. During this time, neither the participants nor the researchers know which medication is being administered.

    The primary goal is to assess treatment discontinuation due to adverse events.

  4. Step 4

    Evaluation of treatment effectiveness

    Effectiveness is evaluated by measuring the reduction in the average number of migraine days per month during months 4 to 6.

    Additional assessments include changes in headache impact and quality of life scores at week 24.

  5. Step 5

    Open-label safety extension

    After the double-blind period, participants may enter an open-label extension to further evaluate the safety of the treatments.

    In this phase, all participants receive the same treatment, and both participants and researchers know which medication is being administered.

Who can join the trial?

4 criteria

  • Must have a documented history of **migraine** (with or without **aura**) for at least 12 months before the first screening visit. A **migraine** is a type of headache that can cause severe pain, and **aura** refers to visual or sensory disturbances that some people experience before a migraine.
  • Must have a history of at least 4 migraine days per month and need preventive treatment for migraines. Preventive treatment is used to reduce the frequency and severity of migraines.
  • Both males and females are eligible to participate.
  • Participants from vulnerable populations are eligible. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.

Who cannot join the trial?

10 criteria

  • Participants who are not able to follow the study instructions or procedures.
  • Individuals with a history of severe allergic reactions to any of the study medications.
  • People who have used other migraine prevention treatments recently.
  • Participants with certain medical conditions that might interfere with the study.
  • Women who are pregnant or breastfeeding.
  • Individuals who are currently participating in another clinical trial.
  • People with a history of drug or alcohol abuse.
  • Participants who have had recent surgery or plan to have surgery during the study.
  • Individuals with uncontrolled high blood pressure.
  • People with certain heart conditions that might affect their safety in the study.
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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 certain receptors in the brain that are involved in the development of migraines. The trial aims to see how well people tolerate this medication and how safe it is for long-term use.

  • Topiramate

    is a medication commonly used to prevent migraines. It is also taken by mouth and works by calming overactive nerve cells in the brain. In this trial, it is used as a comparison to evaluate the effectiveness and safety of atogepant. The study looks at how well participants tolerate the highest dose of topiramate that they can handle.

What is already known about the treatment

  • Atogepant

    Atogepant is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in preventing migraines. It is a relatively new medication in the field of migraine prevention, with ongoing research to establish its safety and tolerability. Atogepant is primarily indicated for the prevention of chronic and episodic migraines. It works by blocking the activity of a protein called calcitonin gene-related peptide (CGRP), which is involved in the transmission of pain and the development of migraines. Atogepant belongs to the pharmacological class of CGRP receptor antagonists.

  • Topiramate

    Topiramate is available in oral tablet and capsule forms and is widely used in medicine for the prevention of migraines and the treatment of epilepsy. It is a well-established medication with extensive literature supporting its use for these conditions. Topiramate is indicated for the prevention of chronic and episodic migraines. It works by stabilizing electrical activity in the brain and reducing the frequency of migraine attacks. Topiramate is classified as an anticonvulsant or antiepileptic drug.

Investigated diseases

Chronic and Episodic Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. Chronic migraine involves headaches occurring on 15 or more days per month for more than three months, with at least eight days having migraine features. Episodic migraine, on the other hand, occurs less frequently, typically fewer than 15 days per month. The progression of migraines can vary, with some individuals experiencing an increase in frequency and severity over time. Migraine attacks can last from a few hours to several days and may be preceded by sensory disturbances known as aura. The condition can significantly impact daily activities and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501172-25-00Protocol codeM22-061Estimated enrolment520 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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