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Study on Rimegepant for Preventing Migraines in Adults with Poor Response to Oral Preventive Medications

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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 migraine headaches, which are severe headaches that can occur with or without warning signs known as aura. The study is testing a treatment called Rimegepant, also known by its code name BHV-3000. Rimegepant is taken as an oral lyophilisate, which means it dissolves in the mouth. The purpose of the study is to evaluate how well Rimegepant works and how tolerable it is for preventing migraines in adults who have not had success with other oral preventive medications.

Participants in the study will be randomly assigned to receive either Rimegepant or a placebo, which looks like the medication but does not contain the active ingredient. 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. This helps ensure that the results are not biased. The study will last for several weeks, during which participants will take the medication every other day and report the number of migraine days they experience each month.

The main goal is to see if there is a reduction in the number of migraine days per month compared to before the study started. Additionally, the study will look at whether participants experience fewer days with moderate or severe headache pain and any changes in their ability to perform daily activities. The results will help determine if Rimegepant is an effective option for people who have not found relief with other migraine prevention treatments.

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 history of migraines, with or without aura, and previous inadequate response to oral preventive medications.

    Participants must have experienced migraines for more than one year, with attacks lasting 4 to 72 hours if untreated, and must be able to distinguish these from tension headaches.

  2. Step 2

    Observation phase

    During this phase, the frequency of migraine days is recorded over a 28-day period.

    This phase helps establish a baseline for comparison during the treatment phase.

  3. Step 3

    Double-blind treatment phase

    Participants are randomly assigned to receive either rimegepant 75 mg or a placebo, administered orally every other day.

    This phase lasts for 12 weeks, during which the number of migraine days is monitored.

  4. Step 4

    Evaluation of primary outcomes

    The primary outcome is the change in the number of migraine days per month from the observation phase to the end of the treatment phase.

  5. Step 5

    Evaluation of secondary outcomes

    Secondary outcomes include the proportion of participants with a 50% reduction in migraine days, changes in migraine days during specific weeks, and improvements in quality of life scores.

Who can join the trial?

11 criteria

  • Have a documented history of **migraine headaches** for at least 1 year. Migraines can occur with or without an **aura**, which are visual or sensory disturbances that some people experience before a migraine.
  • Must have had migraine attacks for more than 1 year before the screening visit.
  • The first migraine attack must have occurred before the age of 50.
  • Migraine attacks should last between 4 to 72 hours if not treated.
  • Experience between 4 to 14 migraine days per month on average in the 3 months before the screening visit.
  • Have between 4 to 14 migraine days during the 28-day observation phase of the study.
  • Be able to tell the difference between a migraine and a tension headache.
  • Have had an inadequate response to at least two to four different types of oral migraine-preventive medications in the past 10 years. This means the medications did not work well or caused side effects.
  • Be at least 18 years old.
  • Meet certain reproductive criteria, which will be explained in more detail in the study protocol.
  • If a woman of childbearing potential, must have a negative pregnancy test before starting the study medication.

Who cannot join the trial?

8 criteria

  • Patients who have a history of severe allergic reactions to the study medication or similar medications.
  • Individuals with other significant health conditions that might interfere with the study, such as uncontrolled high blood pressure or heart disease.
  • Women who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Individuals who have used certain medications that might affect the study results within a specific time frame before the study starts.
  • Patients with a history of substance abuse or dependency.
  • Individuals who have had recent surgery or are planning to have surgery during the study period.
  • Patients who are unable to comply with the study procedures or follow-up visits.
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Investigated drugs

Rimegepant is a medication being studied for its ability to prevent migraines in adults who have not had success with other oral preventive treatments. It is being tested to see how well it can reduce the number of migraine days each month.

What is already known about the treatment

Rimegepant – Rimegepant is administered orally and is currently being studied in clinical trials for its effectiveness in preventing migraine headaches, both with and without aura. It is a medication that has shown promise in reducing the number of migraine days in individuals who have not responded well to other oral preventive treatments. Rimegepant works by blocking a specific receptor in the brain known as the CGRP receptor, which is involved in the development of migraine headaches. It is classified as a CGRP receptor antagonist and is being evaluated for its potential to offer relief to those who suffer from frequent migraines.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. These headaches can occur with or without an aura, which are sensory disturbances that can include visual changes or tingling sensations. Migraines typically progress through four stages: prodrome, aura, headache, and postdrome, although not everyone experiences all stages. The frequency and severity of migraines can vary widely among individuals, with some experiencing them occasionally and others having them frequently. 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 environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513270-21-00Protocol codeC4951012/BHV3000-407Estimated enrolment600 patientsSponsorPfizer Inc.

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