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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Rimegepant for Migraine Prevention

Phase 4
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of onset of migraines prior to 50 years of age
Migraine attacks, on average, lasting 4-72 hours if untreated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months (12 weeks)
Awards & highlights

Study Summary

This trial will compare the migraine-preventing effects of two different doses of rimegepant.

Who is the study for?
This trial is for individuals who have had episodic migraines for at least a year, with onset before age 50. Participants should experience 4-14 migraine attacks per month and not be using any preventive migraine medication or certain painkillers frequently. Women must not be pregnant, breastfeeding, or planning to become pregnant without using contraception.Check my eligibility
What is being tested?
The study aims to test the effectiveness and safety of Rimegepant in preventing episodic migraines when taken daily or every other day compared to a placebo (a substance with no active drug).See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience adverse reactions related to Rimegepant which could include nausea, dizziness, fatigue, dry mouth and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My migraines started before I turned 50.
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My migraines last between 4 to 72 hours without treatment.
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My migraines last between 4 to 72 hours without treatment.
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I have had migraines for at least a year, as per the headache classification.
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I have had 4-14 migraine attacks each month for the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months (12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months (12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function.
Mean change from the Observation Phase
Mean change from the Observation Phase.
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosingExperimental Treatment1 Intervention
Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily Open-Label Extension Phase: Rimegepant 75 mg ODT dosed daily
Group II: Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosingExperimental Treatment1 Intervention
Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
Group III: Placebo comparator dosingPlacebo Group1 Intervention
Double-blind Treatment Phase: matching placebo dosed daily

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,562 Previous Clinical Trials
10,906,460 Total Patients Enrolled
22 Trials studying Migraine
24,161 Patients Enrolled for Migraine
Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,758 Total Patients Enrolled
13 Trials studying Migraine
18,797 Patients Enrolled for Migraine
Biohaven Pharmaceutical Holding Company Ltd.Industry Sponsor
8 Previous Clinical Trials
13,700 Total Patients Enrolled
5 Trials studying Migraine
11,227 Patients Enrolled for Migraine

Media Library

Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05217927 — Phase 4
Migraine Research Study Groups: Placebo comparator dosing, Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing, Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing
Migraine Clinical Trial 2023: Rimegepant Highlights & Side Effects. Trial Name: NCT05217927 — Phase 4
Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217927 — Phase 4
Migraine Patient Testimony for trial: Trial Name: NCT05217927 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals can take part in this research initiative?

"Affirmative. According to clinicaltrials.gov, the medical experiment was first published on March 4th 2022 and has had its most recent update on November 2nd 2022. Moreover, 660 participants are required for this study which is being conducted at 37 distinct venues."

Answered by AI

What potential hazards exist with a daily dosage of Rimegepant 75mg?

"With the Rimegepant 75mg daily dosing receiving a score of 3, our team at Power understands it is safe due to this being a Phase 4 trial and thus already approved for use."

Answered by AI

Is access to this medical experiment available presently?

"According to the official clinicaltrials.gov website, this trial is actively recruiting participants and was initially posted on March 4th 2022 with its last amendment being done on November 2nd 2022."

Answered by AI

What is the current geographic scope of this clinical trial?

"The current trail is running at 37 distinct sites, including nearby locations such as Stouffville, Gurnee and East Greenwich. To minimize travel obligations for participants, it can be advantageous to choose the closest trial site to you when enrolling."

Answered by AI

Who else is applying?

What state do they live in?
California
Rhode Island
New York
How old are they?
18 - 65
What site did they apply to?
California Neuroscience Research Medical Group, Inc.
Neurology Offices of South Florida, PLLC
Montefiore Medical Center; Headache Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

pain releif money for trial. I’ve tried a bunch of different medications and nothing seems to help, I’ve been suffering with migraines since I was 6, and I’m over it. I need some kind of help.
PatientReceived 1 prior treatment
~128 spots leftby Oct 2024