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NCT Number: NCT06616194

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.

Rimegepant is a tablet that dissolves when you put it on or under your tongue.

The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours

In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.

Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.

In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.

Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stollery Children's Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least a 6 month history of migraine (with or without aura)
  • 15 or more headache days/month
  • 8 or more migraine days/month
  • Migraine lasting 4-72 hours if untreated

Exclusion criteria

  • Unrelenting headache
  • Current psychiatric condition uncontrolled or untreated
  • History of suicidal behavior or the subject is at risk of self-harm
  • History of alcohol abuse and/or illicit drug use
  • History of severe drug allergy
  • Use of more than one medication for migraine prevention/prophylaxis
  • Participation in another clinical trial at the same time

Treatment and study plan

Rimegepant

Drug

Rimegepant 75 mg orally disintegrating tablets

Placebo

Drug

Matching placebo oral disintegrating tablets

Primary outcomes

  1. Number of migraine days per month

    Time frame: 12 Weeks

    Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month

Secondary outcomes

  1. Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month

    Time frame: 12 Weeks

    Change in the use of acute migraine-specific medication days per month

  2. Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month

    Time frame: 12 Weeks

    Change in headache days per month

  3. Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month

    Time frame: 12 weeks

    Change in moderate or severe migraine days per month

  4. Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score

    Time frame: 12 Weeks

    Change in the Quality of Life

  5. Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month

    Time frame: 12 Weeks

    Change in headache and migraine rescue medication(s) used

  6. Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall

    Time frame: Up to 15 months

    Safety and tolerability of the study drug

  7. Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken

    Time frame: Up to 15 Months

    Safety monitoring of adverse events of special interest

  8. Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score

    Time frame: 12 Weeks

    Change in the Quality of Life

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 27, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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