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Calcitonin Gene-Related Peptide (CGRP) Antagonist
Rimegepant for Migraine
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours post-dose
Awards & highlights
Study Summary
This trial is testing a new drug to help people with migraines who can't take triptans.
Who is the study for?
Adults who suffer from migraines lasting 4-72 hours, have fewer than 15 headache days a month, and can't use triptan due to intolerance or contraindications like heart disease. They must be able to tell migraines apart from other headaches and have had migraines for over a year before turning 50.Check my eligibility
What is being tested?
The trial is testing Rimegepant's effectiveness in treating acute migraine attacks compared to a placebo in adults who cannot take triptans. Participants will randomly receive either the medication or placebo to assess relief and tolerability.See study design
What are the potential side effects?
While not specified here, common side effects of migraine medications like Rimegepant may include nausea, drowsiness, dry mouth, and potential allergic reactions. Individual experiences with side effects can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RimegepantExperimental Treatment1 Intervention
Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT)
Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)
Group II: PlaceboPlacebo Group2 Interventions
Placebo - Double-blind (DB) Phase: One dose of matching placebo
Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine
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?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,426 Total Patients Enrolled
22 Trials studying Migraine
23,938 Patients Enrolled for Migraine
Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,535 Total Patients Enrolled
13 Trials studying Migraine
18,574 Patients Enrolled for Migraine
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,621 Total Patients Enrolled
17 Trials studying Migraine
17,465 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on a stable dose of migraine prevention medication (not CGRP antagonists) for at least 3 months.I've had fewer than 15 headache days per month for the last 3 months.Triptan medications are not suitable for me.I have a history of specific severe headaches.I've had fewer than 15 headache days per month for the last 3 months.I have had headaches on 15 or more days each month for the last 3 months.My migraine attacks last from 4 to 72 hours without treatment.I can tell the difference between my migraine and other types of headaches.I have had migraines for over a year, starting before I was 50.I have a long-term pain condition like fibromyalgia.I've had 4 to 14 migraine days each month for the last 3 months.I do not have any major neurological issues other than migraines.I've had 4 to 14 migraine days each month for the last 3 months.I can tell the difference between my migraine and other types of headaches.I have had migraines for over a year, starting before I was 50.My migraines last between 4 to 72 hours without treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Rimegepant
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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: NCT05509400 — 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 participants have been enlisted for this experiment?
"Affirmative. Information hosted on clinicaltrials.gov reveals that this medical investigation, initially posted on October 18th 2022, is actively looking for volunteers. The study seeks to enlist 600 participants from eighteen distinct centres."
Answered by AI
What is the number of healthcare facilities currently conducting this experiment?
"Currently, 18 different sites are participating in this research trial. Bronx, Los Angeles and Tomball are just a few of the locations taking part - it is advisable to pick one closest to you so as to reduce transportation burden if you do decide to enroll."
Answered by AI
Does the age limitation for enrollment of this trial extend beyond 45 years?
"In alignment with the study's entry requirements, applicants must be 18 years or older and younger than 65."
Answered by AI
Is Rimegepant a safe option for medical treatment?
"After careful evaluation, our experts at Power awarded Rimegepant a score of 3 as this is an approved Phase 4 treatment."
Answered by AI
Are there any slots available for this clinical exploration?
"Clinicaltrials.gov confirms that this scientific endeavour, which was first advertised on October 18th 2022 is still recruiting participants. The trial's details have been recently updated on November 2nd 2022."
Answered by AI
Do I meet the prerequisites to participate in this exploration?
"Candidates aged 18 to 65 with documented migraine diagnoses are eligible for this research trial. It is anticipated that 600 participants will be enrolled in total."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
Washington
What site did they apply to?
WR-Mount Vernon Clinical Research, LLC
DM Clinical Research
Other
Clinical Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
What questions have other patients asked about this trial?
How long do screenings take? Is there financial support?
PatientReceived no prior treatments
Why did patients apply to this trial?
I want to find a good solution for migraine that will allow me to feel better, more functional in life.
PatientReceived 2+ prior treatments
I have tried multiple medicines. I currently use triptans but find they are becoming less and less effective.
PatientReceived 2+ prior treatments
My headaches are progressively getting worst. It is uprooting my daily life. Over the counter medications is not working.
PatientReceived 2+ prior treatments
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