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Study on Rimegepant for Preventing Migraines in Children and Teens Aged 6 to 17

Fast replyRegistered drugNo 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 in children and adolescents aged 6 to under 18 years. Migraine is a type of headache that can cause severe pain, often accompanied by nausea, vomiting, and sensitivity to light and sound. The treatment being tested in this study is called Rimegepant, which is taken as an oral lyophilisate, a form that dissolves in the mouth. The study will compare the effects of Rimegepant with a placebo to see how well it works in reducing the number of migraine days each month.

The purpose of the study is to evaluate the effectiveness and safety of Rimegepant in preventing migraines. Participants will be randomly assigned to receive either Rimegepant or a placebo. The study will last for several weeks, during which participants will take the medication and report the number of migraine days they experience. The goal is to see if Rimegepant can significantly reduce the frequency of migraines compared to the placebo.

Throughout the study, participants will be monitored to ensure their safety and to gather information on how the treatment affects their quality of life. The study aims to provide valuable insights into whether Rimegepant can be an effective preventive treatment for migraines in young people, potentially offering a new option for managing this challenging 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, the participant will be assessed to ensure they meet the necessary criteria, such as having a history of migraine and being within the age range of 6 to less than 18 years.

    Participants must have experienced a certain number of migraine days and have a specific score on the Pediatric Migraine Disability Assessment Scale.

  2. Step 2

    Observation period

    During this period, the participant's migraine frequency and severity will be monitored to establish a baseline for comparison during the treatment phase.

  3. Step 3

    Randomization and treatment

    Participants will be randomly assigned to receive either rimegepant or a placebo. Rimegepant is administered as a 75 mg oral lyophilisate, which is a form of medication that dissolves in the mouth.

    The treatment phase lasts for 12 weeks, during which the participant will take the medication as directed.

  4. Step 4

    Monitoring and assessment

    Throughout the treatment phase, the participant's migraine days will be recorded to evaluate the effectiveness of the treatment.

    The primary goal is to observe a reduction in the number of migraine days per month compared to the baseline.

  5. Step 5

    Completion of the study

    At the end of the 12-week treatment phase, the participant's overall experience and any changes in their quality of life will be assessed.

    The study aims to determine if there is a significant improvement in migraine prevention for those taking rimegepant compared to the placebo.

Who can join the trial?

10 criteria

  • The patient must have had migraines for at least 6 months. A migraine is a type of headache that can cause severe pain, often on one side of the head, and may come with other symptoms like nausea or sensitivity to light.
  • The patient should have 14 or fewer headache days per month in the 3 months before the study starts.
  • The patient should have 6 or more migraine days during the observation period of the study.
  • The patient should have 14 or fewer headache days during the observation period.
  • The patient should have a Pediatric Migraine Disability Assessment Scale (PedMIDAS) score between 11 and 50. This score measures how much migraines affect daily activities, with higher scores indicating more disruption.
  • The patient must be able to tell the difference between a migraine and other types of headaches, like tension or cluster headaches.
  • Migraine attacks should last between 4 to 72 hours if not treated.
  • If the patient is taking medication to prevent migraines, the dose must have been stable for at least 3 months before the study and should not change during the study.
  • The patient must be between 6 and less than 18 years old at the time of giving consent to participate.
  • The patient must weigh at least 40 kg (or at least 15 kg for younger children) at the start of the study.

Who cannot join the trial?

8 criteria

  • Patients who are not between the ages of 12 and 17 years old cannot participate.
  • Patients who do not have episodic migraine cannot participate. Episodic migraine means having migraine headaches on some days, but not every day.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have had an allergic reaction to the study medication or similar medications cannot participate.
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Investigated drugs

Rimegepant is a medication being studied for its ability to prevent migraines in children and adolescents aged 6 to 18 years. It is being tested to see if it can reduce the number of migraine days each month. This medication is taken to help manage and prevent the occurrence of migraines, aiming to improve the quality of life for young individuals who experience these headaches frequently.

What is already known about the treatment

Rimegepant – Rimegepant is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in preventing migraines in children and adolescents aged 6 to 18. It is a relatively new medication in the field of migraine treatment, with ongoing research to establish its safety and efficacy. The primary therapeutic indication for rimegepant is the prevention of migraines. At the molecular level, rimegepant 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

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 nausea, vomiting, and sensitivity to light and sound. Migraines can last for hours or even days and may occur with or without an aura, which includes visual disturbances or other sensory changes. The frequency of migraines can vary, with some individuals experiencing them occasionally and others having them more frequently. Over time, migraines can become more predictable in their pattern, but the severity and specific symptoms can differ from one episode to another.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-512382-13-00Protocol codeC4951009Estimated enrolment1 074 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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