Image of Michigan Headache & Neurological Institute in Ann Arbor, United States.

Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist

Rimegepant for Migraine

Osaka, Japan

Phase 3

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* At least a 6 month history of migraine (with or without aura)

* 15 or more headache days/month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months

Awards & highlights

Pivotal Trial

Summary

This trial is studying the effects of a medication called rimegepant on teenagers who suffer from frequent migraine attacks. Participants will take either the rimegepant tablet or an inactive tablet every

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Who is the study for?

This trial is for adolescents with frequent migraines, specifically those who have had a history of migraine for at least 6 months, experience headaches on 15 or more days per month, and suffer from migraines on at least 8 of those days. Each migraine should last between 4 to 72 hours if untreated.Check my eligibility

What is being tested?

The study tests Rimegepant, a dissolvable tablet for treating frequent migraines in adolescents. Participants will be randomly divided into two groups: one receiving Rimegepant and the other a placebo every other day for three months. In the second phase lasting one year, all participants receive Rimegepant.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions to oral medications such as digestive discomfort, dizziness or sleepiness. The safety profile will be closely monitored through regular health checks and blood samples.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had migraines for at least 6 months.

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I experience 15 or more headache days each month.

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I experience 8 or more migraine days each month.

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My migraines last between 4 to 72 hours without treatment.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of migraine days per month

Secondary study objectives

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

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

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

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