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Study of rimegepant for preventing chronic migraine in adolescents aged 12 to 17 years

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on preventing chronic migraine in young people aged 12 to under 18 years. Chronic migraine is a condition where a person experiences headaches on 15 or more days per month, with at least 8 of these being migraine headaches. These migraine attacks typically last between 4 to 72 hours when left untreated and can significantly impact daily life.

The study will test a medication called rimegepant sulfate (also known as PF-07899801), which belongs to a group of medicines called calcitonin gene-related peptide antagonists. This medicine comes as an orodispersible tablet that dissolves in the mouth and is taken by mouth. The purpose is to determine if rimegepant sulfate works better than placebo in preventing migraines in adolescents with chronic migraine.

The study will last several months and will have two parts. In the first part, participants will receive either rimegepant sulfate or placebo without knowing which one they are taking. After this initial phase, there will be an extended period where all participants will receive the active medication. Throughout the study, participants will need to keep track of their headache days and complete questionnaires about how migraines affect their daily activities.

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

    Initial observation phase

    You will enter an observation phase to document your migraine patterns

    During this phase, you will need to record your headache days and migraine days

    The observation will confirm if you experience at least 15 headache days and 8 migraine days per month

  2. Step 2

    Treatment phase begins

    You will be randomly assigned to receive either rimegepant sulfate or a placebo (inactive substance)

    The medication will be taken by mouth

    This double-blind treatment phase will last for 12 weeks, meaning neither you nor the doctor will know which treatment you are receiving

  3. Step 3

    Monitoring during treatment

    Throughout the 12-week period, you will need to track:

    The number of days you experience migraines

    The number of days you use medications for headache relief

    The severity of your headaches (moderate or severe)

    You will complete quality of life questionnaires at the start and at week 12

  4. Step 4

    Open-label extension phase

    After the initial 12-week period, you may enter the open-label extension phase

    During this phase, all participants will receive the actual medication (rimegepant sulfate)

    Your health will continue to be monitored for any side effects or complications

  5. Step 5

    Study completion

    The study is expected to continue until December 2027

    Throughout the study, doctors will monitor your health and any side effects

    Your participation will help evaluate if rimegepant sulfate is effective for preventing migraines in adolescents

Who can join the trial?

11 criteria

  • Must be between 12 and 17 years old at the time of joining the study
  • For participants from EU countries and India only: Must weigh more than 40 kilograms
  • Must have experienced migraines for at least 6 months
  • Must have 15 or more headache days per month in the 3 months before screening
  • Must have 8 or more migraine days per month in the 3 months before screening
  • Must be able to tell the difference between migraine attacks and other types of headaches
  • Typical migraine attacks must last between 4 and 72 hours when not treated
  • Must be able to understand the study information document
  • Parent or legal guardian must be able to read and understand the consent document
  • Must be willing to complete all required questionnaires under supervision of legal representative
  • Both participant and parent/legal guardian must sign the required consent forms before any study procedures begin

Who cannot join the trial?

15 criteria

  • History of any chronic pain condition other than migraine (pain lasting more than 3 months)
  • Previous diagnosis of medication overuse headache (frequent use of pain medications leading to more headaches)
  • Current use of other preventive migraine medications
  • Presence of any severe psychiatric conditions that are not well controlled
  • History of stroke or other serious brain conditions
  • Pregnant or breastfeeding women
  • Active liver disease or abnormal liver function tests
  • History of allergic reactions to similar medications
  • Use of certain medications that might interact with the study drug
  • Participation in another clinical trial within the past 30 days
  • Uncontrolled high blood pressure
  • History of substance abuse within the past year
  • Serious heart conditions or abnormal heart rhythm
  • Unable to follow study procedures or complete headache diary
  • Any condition that, in the investigator's opinion, makes participation unsafe
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Investigated drugs

  • Rimegepant

    is a medication used to prevent migraine headaches. It belongs to a class of drugs called CGRP receptor antagonists. This medication works by blocking specific proteins in the brain that are involved in causing migraine pain. It is being studied as a preventive treatment for chronic migraines in adolescents, which means it's taken regularly to reduce how often migraines occur and how severe they are, rather than just treating migraine attacks when they happen.

  • Placebo

    is an inactive substance that looks exactly like the real medication but contains no active drug. It is used in this study to help determine how effective rimegepant is by comparing the results between patients who receive the actual medication and those who receive the placebo.

What is already known about the treatment

Rimegepant - A novel oral medication specifically designed for the prevention and treatment of chronic migraine in adolescents, belonging to the class of CGRP (calcitonin gene-related peptide) receptor antagonists. The medication works by blocking CGRP receptors in the brain, which play a crucial role in the development of migraine attacks, helping to reduce the frequency and severity of headaches. Administered in tablet form, rimegepant represents a targeted approach to migraine prevention, offering a treatment option for patients aged 12 to 18 years who experience chronic migraines, defined as 15 or more headache days per month. The drug is currently being evaluated in Phase 3 clinical trials to establish its safety and efficacy in adolescent populations.

Investigated diseases

Chronic Migraine - A neurological condition characterized by headaches occurring 15 or more days per month, with at least 8 of those being migraines, for more than three months. The headaches typically cause pulsating or throbbing pain, often on one side of the head. Patients may experience nausea, sensitivity to light and sound, and visual disturbances called auras. The condition can fluctuate in intensity throughout the month, with some headaches being more severe than others. The frequent headaches can significantly impact daily activities and quality of life.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-505601-16-00Protocol codeC4951013Estimated enrolment200 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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