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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had migraines for at least 1 year.
Select...
My migraines last between 4 to 72 hours without treatment.
Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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
~12670
Find a Location
Who is running the clinical trial?
Biohaven Pharmaceutical Holding Company Ltd.Lead Sponsor
8 Previous Clinical Trials
13,792 Total Patients Enrolled
5 Trials studying Migraine
11,319 Patients Enrolled for Migraine
PfizerLead Sponsor
4,568 Previous Clinical Trials
10,911,601 Total Patients Enrolled
22 Trials studying Migraine
24,253 Patients Enrolled for Migraine
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,092,769 Total Patients Enrolled
17 Trials studying Migraine
17,780 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had 4-14 migraines a month for the last 3 months.I have had migraines for over a year, with 4-14 attacks a month, starting before I was 50.I have had migraines for at least 1 year.My migraines started before I turned 50.My migraines last between 4 to 72 hours without treatment.Please provide more details for an accurate summary.I am 18 years old or older.I have used opioid or barbiturate medication for 4+ days a month in the last 3 months.I have high blood pressure or diabetes that is not well-managed.
Research Study Groups:
This trial has the following groups:- Group 1: Rimegepant
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Migraine Patient Testimony for trial: Trial Name: NCT05207865 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks have been associated with administering Rimegepant to patients?
"With the completion of Phase 4 trials, Rimegepant has been approved and is thus given a safety rating of 3."
Answered by AI
Could you provide an estimate of the overall cohort size involved in this clinical investigation?
"This medical trial calls for 125 participants that fulfill the established criteria. Patients can find a suitable clinical site at AIM in Hawthorne, California or WR-ClinSearch, LLC. located in Chattanooga, Tennessee."
Answered by AI
Is this research initiative currently seeking participants?
"Absolutely. Clinicaltrials.gov reveals that this research, which was initially posted in March 15th 2022, is still open for enrollment. 125 individuals are required from 19 distinct clinical centres."
Answered by AI
Are there any healthcare facilities conducting this research in North America?
"In addition to AIM in Hawthorne, California, WR-ClinSearch LLC. located in Chattanooga, Tennessee and Chase Medical Research LLC. based out of Waterbury Connecticut are hosting this trial alongside another 19 medical centres across the US."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Other
New Jersey
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Clinical Research Philadelphia, LLC
CVS HealthHUB - Runnemede
Clinical Research Philadelphia
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+
Why did patients apply to this trial?
Migraines are getting worse. To relieve the light sensitivity. Their making me go crazy and very forgetful.
PatientReceived no prior treatments
I need something that will actually help with my migraines. I am currently on Sumatriptan and it only works to relieve my headaches temporarily.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
any compensation for gas travel? I am on other medications for other ailments, is that a deal breaker for doing this study?
PatientReceived 1 prior treatment
How long does the screening period take? Is it constant office visits? What kinda of hours thought out the day are available?
PatientReceived 1 prior treatment
My neurologist wants to start me on Toparate. I am on 29 different meds for different conditions including high BP, HIV, and asthma. Would this prevent me from this trial?
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- Advanced Investigative Medicine, Inc.: < 24 hours
- CVS HealthHUB - Runnemede: < 24 hours
- Clinical Research Philadelphia, LLC: < 48 hours
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