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Study on Rimegepant for Treating Migraine in Adults Who Cannot Use Triptans

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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 a medication called Rimegepant for treating migraine attacks in adults who cannot use another type of medication known as triptans. Migraines are severe headaches that can occur with or without warning signs, known as aura, and can last from a few hours to several days if untreated. The study aims to compare how well Rimegepant works in relieving migraine pain compared to a placebo.

Participants in the study will be randomly assigned to receive either Rimegepant 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. The main goal is to see if Rimegepant can reduce the intensity of migraine pain within two hours after taking the medication. The study will also look at other factors, such as whether participants need additional medication within 24 hours and how the medication affects their ability to function normally during a migraine attack.

The trial will take place over a period of time, and participants will be monitored to assess the medication's impact on their migraine symptoms. The study will help determine if Rimegepant is a suitable option for those who cannot use triptans, providing valuable information on its potential benefits and any side effects. The results will contribute to understanding how Rimegepant can be used in managing migraines effectively.

The research process

The trial runs in 6 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 history of migraine attacks lasting between 4 to 72 hours, occurring 4 to 14 days per month.

    Participants must be at least 18 years old and unsuitable for triptan use.

  2. Step 2

    Baseline visit

    A baseline visit is conducted to ensure all criteria are met, including a negative pregnancy test for women of childbearing potential.

    Participants must comply with restrictions on certain medications.

  3. Step 3

    Randomized treatment phase

    Participants are randomly assigned to receive either Rimegepant 75 mg or a placebo.

    The medication is administered as an oral lyophilisate, which dissolves in the mouth.

  4. Step 4

    Treatment administration

    The medication is taken during a migraine attack, with the goal of assessing headache pain relief at 2 hours post-dose.

    Participants are monitored for headache pain intensity and functional disability levels.

  5. Step 5

    Follow-up assessments

    Participants report their headache pain intensity and any functional disability at various time points up to 48 hours after taking the medication.

    The study measures the percentage of participants with reduced headache pain and improved functional ability.

  6. Step 6

    End of study

    The study is estimated to conclude by July 2025.

    Final assessments are conducted to evaluate the overall efficacy and tolerability of the treatment.

Who can join the trial?

11 criteria

  • Have a documented history of **migraine attacks** (with or without aura) for at least 1 year.
  • Migraine attacks must have started before the age of 50.
  • Migraine attacks should last between 4 to 72 hours if not treated.
  • Experience 4 to 14 migraine days per month on average over the 3 months before the screening visit.
  • Be able to tell the difference between migraine attacks and tension headaches.
  • If taking preventive migraine medication (except for CGRP antagonists), the dose must have been stable for at least 3 months before the screening visit and should not change during the study.
  • Triptan medications are not suitable for the participant.
  • Be at least 18 years old.
  • Meet specific reproductive criteria.
  • Women of childbearing potential must have a negative urine pregnancy test before starting the study drug.
  • Be able to follow the rules about not using certain medications and therapies during the study.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently taking medications that could affect the study results.
  • Patients who have had recent surgery or medical procedures that could impact their participation.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or similar drugs.
  • Patients who have a history of severe allergic reactions.
  • Patients who have certain mental health conditions that could affect their ability to participate.
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Investigated drugs

Rimegepant is a medication being studied for its effectiveness in treating migraine headaches. It is used to relieve the pain associated with migraines in adults who cannot use triptan medications. The trial aims to see how well rimegepant works in reducing migraine pain within two hours after taking the dose.

What is already known about the treatment

Rimegepant – Rimegepant is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating acute migraine attacks, particularly in adults who cannot use triptans. The medication is known for its ability to relieve migraine headache pain within two hours of dosing. Rimegepant works by blocking the receptor for a protein called CGRP, which is involved in the development of migraine headaches. It is classified as a CGRP receptor antagonist.

Investigated diseases

Migraine – A migraine is a type of headache characterized by intense, throbbing pain, often on one side of the head. It can be accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. Some individuals experience an aura, which includes visual disturbances or other sensory changes, before the headache begins. Migraines can last from a few hours to several days and may vary in frequency and intensity. The exact cause of migraines is not fully understood, but they are believed to involve changes in brain chemicals and nerve pathways. Triggers can include stress, certain foods, hormonal changes, and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513269-37-00Protocol codeC4951004/BHV3000-406Estimated enrolment600 patientsSponsorPfizer Inc.

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