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Calcitonin Gene-Related Peptide (CGRP) Antagonist

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

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
Select...
I have had migraines for at least 1 year.
Select...
My migraines last between 4 to 72 hours without treatment.
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I am 18 years old or older.

Timeline

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.

Side effects data

From 2023 Phase 4 trial • 580 Patients • NCT05127486
2%
Covid-19
2%
Nasopharyngitis
1%
Sinusitis
1%
Nausea
1%
Injection site pain
1%
Fatigue
1%
Migraine
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rimegepant
Galcanezumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: RimegepantExperimental Treatment1 Intervention
rimegepant 75 mg ODT daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimegepant
2021
Completed Phase 4
~12660

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceutical Holding Company Ltd.Lead Sponsor
8 Previous Clinical Trials
13,885 Total Patients Enrolled
5 Trials studying Migraine
11,373 Patients Enrolled for Migraine
PfizerLead Sponsor
4,625 Previous Clinical Trials
14,283,909 Total Patients Enrolled
24 Trials studying Migraine
24,683 Patients Enrolled for Migraine
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,485 Total Patients Enrolled
19 Trials studying Migraine
18,210 Patients Enrolled for Migraine

Media Library

Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05207865 — Phase 4
Migraine Research Study Groups: Rimegepant
Migraine Clinical Trial 2023: Rimegepant Highlights & Side Effects. Trial Name: NCT05207865 — Phase 4
Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05207865 — Phase 4
Migraine Patient Testimony for trial: Trial Name: NCT05207865 — Phase 4
~0 spots leftby Oct 2024