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

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Rimegepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06616194

BHV3000-320 (Other Identifier)

C4951013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Rimegepant

Experimental group

Description:

Experimental medicine under study

Treatment:

Drug: Rimegepant

Placebo

Placebo Comparator group

Description:

A placebo does not have any medicine in it but looks just like the medicine being studied.

Treatment:

Drug: Placebo