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Calcitonin Gene-Related Peptide (CGRP) Antagonist
Rimegepant for Migraine Prevention
Phase 4
Recruiting
Research Sponsored by Biohaven Pharmaceuticals, Inc.
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 week 1 to 12 of dbt phase
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial tests a new migraine prevention medicine to see if it helps people with a history of bad response to other treatments.
Who is the study for?
This trial is for adults who've had migraines for over a year, with onset before age 50, and experience 4-14 migraine days per month. They must have tried and not responded well to 2-4 types of oral migraine-preventive meds in the past decade. Participants should be able to tell their migraines apart from other headaches.
What is being tested?
The study tests Rimegepant's effectiveness in preventing migraines compared to a placebo (a substance with no therapeutic effect). It targets those who haven't found relief with standard oral preventive medications. The goal is to see if Rimegepant can reduce the frequency or severity of migraines.
What are the potential side effects?
While specific side effects are not listed here, 'tolerability' suggests that potential side effects could include typical drug reactions such as nausea, dizziness, fatigue or more specific ones related to migraine treatments like dry mouth or chest tightness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1 to 12 of dbt phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 to 12 of dbt phase
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Compare the efficacy of rimegepant (75 mg) to placebo
Side effects data
From 2023 Phase 4 trial • 580 Patients • NCT051274862%
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
Awards & Highlights
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.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rimegepant 75 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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 Pharmaceuticals, Inc.Lead Sponsor
48 Previous Clinical Trials
36,998 Total Patients Enrolled
13 Trials studying Migraine
18,892 Patients Enrolled for Migraine
PfizerLead Sponsor
4,660 Previous Clinical Trials
17,876,756 Total Patients Enrolled
26 Trials studying Migraine
26,195 Patients Enrolled for Migraine
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,545 Previous Clinical Trials
14,917,921 Total Patients Enrolled
21 Trials studying Migraine
19,722 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My migraines last from 4 to 72 hours without treatment.I have had migraines for over a year, starting before I was 50.My migraines last from 4 to 72 hours without treatment.I've had 4 to 14 migraine days monthly in the last 3 months.I've had fewer than 15 headache days a month for the last 3 months.I've had 15 or more headache days each month for the last 3 months.I have a history of severe types of headaches or migraines.I can tell the difference between my migraine and other types of headaches.I do not have any major neurological issues besides migraines.I've had fewer than 15 headache days per month for the last 3 months.I have had migraines for over a year, starting before I was 50.I've tried 2-4 types of migraine prevention pills in the last 10 years without success.I have had 4 to 14 migraine days each month for the last 3 months.I've tried more than 4 types of migraine prevention pills without success.I can tell my migraine attacks apart from other headaches and have tried 2-4 types of migraine prevention treatments that didn't work well in the last 10 years.I have a long-term pain condition like fibromyalgia.I've had 4 to 14 migraine days each month for the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Rimegepant 75 mg
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: NCT05518123 — Phase 4
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