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

Last updated: January 21, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Pain

Pain (Pediatric)

Oral Facial Pain

Treatment

Rimegepant

Placebo

Clinical Study ID

NCT06616194
C4951013
BHV3000-320
C4951013
  • Ages 12-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Rimegepant
Phase: 3
Study Start date:
November 15, 2024
Estimated Completion Date:
December 15, 2027

Connect with a study center

  • Konan Medical Center

    Kobe, Hyogo 658-0064
    Japan

    Active - Recruiting

  • Yamaguchi Clinic

    Nishinomiya, Hyōgo 663-8204
    Japan

    Site Not Available

  • Tominaga Clinic

    Osaka-Shi, Osaka 556-0015
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo 151-0051
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Shubuya-ku, Tokyo 151-0051
    Japan

    Site Not Available

  • Nagaseki Headache Clinic

    Kai, Yamanashi 400-0124
    Japan

    Active - Recruiting

  • Tanaka Neurosurgical Clinic

    Kagoshima, 892-0844
    Japan

    Active - Recruiting

  • Tennoji Department of Neurosurgery

    Osaka, 545-0053
    Japan

    Active - Recruiting

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Granger Medical Holladay - Holladay Clinic

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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