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Study on Atogepant for Preventing Menstrual Migraine in Women

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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, safety, and tolerability of a medication called Atogepant for the preventive treatment of Menstrual Migraine. Menstrual Migraine is a type of headache that occurs in connection with a woman's menstrual cycle. The study aims to see how well Atogepant works in preventing these migraines compared to a placebo, which is a substance with no active medication.

Participants in the study 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 main part of the study. This helps ensure that the results are not biased. The study will also include an "open-label extension," where all participants may receive Atogepant after the initial phase, allowing researchers to gather more information about the medication's long-term effects.

The main goal of the study is to evaluate how Atogepant, taken for seven consecutive days, affects the number of migraine days during the perimenstrual period, which is the time around the start of menstruation. The study will look at changes in the number of migraine days over three menstrual cycles. Participants will be monitored for any side effects and how well they tolerate the medication. The study is expected to continue until 2027, providing valuable insights into the potential benefits of Atogepant for those suffering from Menstrual Migraine.

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

    Introduction to the study

    Upon joining the study, the participant will be informed about the purpose of the trial, which is to evaluate the effectiveness, safety, and tolerability of atogepant for preventing menstrual migraines.

    The participant will be briefed on the study's design, which includes a double-blind phase where neither the participant nor the researchers know who receives the actual medication or a placebo.

  2. Step 2

    Medication administration

    The participant will receive either atogepant or a placebo in the form of a tablet. The medication is taken orally.

    The participant will take the medication consecutively for 7 days during each menstrual cycle.

  3. Step 3

    Monitoring and recording

    Throughout the study, the participant will use an electronic diary to record migraine occurrences, including the number of migraine days and the severity of headaches.

    The participant will document any use of acute medication for migraines and any disability or impairment experienced during the perimenstrual period.

  4. Step 4

    Evaluation of results

    The primary goal is to assess the change in the number of migraine days during the perimenstrual period over three menstrual cycles.

    Secondary evaluations include the reduction in migraine days, the use of acute medication, and the level of disability or impairment experienced.

  5. Step 5

    Completion of the study

    The study is expected to conclude by August 2027, with the participant's involvement ending after the completion of the trial phases.

    The participant will be informed of the study's findings and any potential implications for the treatment of menstrual migraines.

Who can join the trial?

6 criteria

  • Participants must be adult individuals who are at least 18 years old.
  • Participants must have regular menstrual cycles that last between 21 to 35 days. A menstrual cycle is the time from the start of one period to the day before the next period starts.
  • Participants must have a history of migraine (with or without aura) for at least 12 months before the first visit or screening. A migraine is a type of headache that can cause severe pain, often accompanied by nausea and sensitivity to light or sound. An aura is a visual or sensory disturbance that some people experience before a migraine.
  • The first migraine must have started before the participant was 50 years old.
  • Participants must meet the criteria for pure menstrual migraine or menstrually-related migraine with or without aura. This means that in at least 2 out of 3 menstrual cycles, the participant experiences migraine attacks starting from two days before to three days after the onset of menstruation, as determined by the study investigator.
  • During the screening period, participants must record 3 perimenstrual periods (PMPs) in an electronic diary. A PMP is the time around the start of menstruation. In at least 2 out of 3 PMPs, participants must experience and record a migraine attack in the diary, with at least one day being a migraine day.

Who cannot join the trial?

8 criteria

  • Participants must not have any other type of headache disorder besides Menstrual Migraine.
  • Participants should not be pregnant or planning to become pregnant during the study.
  • Participants must not be breastfeeding.
  • Participants should not have any serious medical conditions that could interfere with the study.
  • Participants must not have a history of drug or alcohol abuse.
  • Participants should not be taking any medications that could interfere with the study treatment.
  • Participants must not have participated in another clinical trial within the last 30 days.
  • Participants should not have any known allergies to the study medication.
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Investigated drugs

Atogepant is a medication being studied for its ability to prevent menstrual migraines. It is taken for a short period, specifically 7 days, to see if it can reduce the frequency or severity of migraines that occur around the menstrual cycle. The study aims to determine how effective, safe, and tolerable this medication is for individuals experiencing these types of migraines.

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 menstrual migraines. It is in the late stages of clinical research, specifically a Phase 3 trial, which indicates it is close to potential approval for medical use. The main therapeutic indication for atogepant is the prevention of menstrual migraines. At the molecular level, atogepant works by blocking the calcitonin gene-related peptide (CGRP) receptor, which is involved in the development of migraine headaches. It is classified pharmacologically as a CGRP receptor antagonist.

Investigated diseases

Menstrual Migraine – Menstrual migraine is a type of headache disorder that occurs in women around the time of their menstrual period. It is characterized by severe, throbbing pain, usually on one side of the head, and can be accompanied by nausea, vomiting, and sensitivity to light and sound. These migraines typically occur in the days leading up to menstruation and may continue into the menstrual period. The hormonal changes associated with the menstrual cycle are believed to trigger these migraines. Unlike other types of migraines, menstrual migraines often do not have an aura, which is a sensory disturbance that can precede the headache. The frequency and severity of menstrual migraines can vary from one menstrual cycle to another.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512946-41-00Protocol codeM24-859Estimated enrolment463 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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