Daily Rimegepant for Migraine Prevention

Phase 4

Recruiting

Research Sponsored by Biohaven Pharmaceutical Holding Company Ltd.

Eligibility Criteria Checklist

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

Must have

Subject has at least 1 year history of episodic migraine (with or without aura) consistent with

Migraine attacks, on average, lasting 4 -72 hours if untreated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over a 6 month period

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will study the safety of taking rimegepant daily to prevent migraines.

Who is the study for?

This trial is for adults over 18 with a history of episodic migraines, experiencing 4-14 attacks per month. Participants should have had migraines for at least one year and typically last between 4 to 72 hours if untreated. It's not suitable for those who started having migraines before age 50 or use opioids/barbiturates frequently.

What is being tested?

The study tests the long-term safety and tolerability of daily doses of Rimegepant, a medication aimed at preventing episodic migraines. The focus is on understanding how well individuals can handle taking this drug every day over an extended period.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to daily Rimegepant usage which could include typical migraine medication side effects like nausea, dizziness, dry mouth, or sleepiness.

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 1 year.

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My migraines last between 4 to 72 hours without treatment.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over a 6 month period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over a 6 month period

This trial's timeline: 3 weeks for screening, Varies for treatment, and over a 6 month period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety as measures by, adverse Events that occur in at least 5% of subjects by intensity; related serious adverse events (SAEs); and adverse events lead to study drug discontinuation as well as grade 3 and 4 laboratory abnormalities.