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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
Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
4 to 14 migraine days per month, on average, across the 3 months prior to the Screening Visit (month is defined as 28-days for the purpose of this protocol).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 to 12 of dbt phase
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had migraines for over a year, starting before I was 50.
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I've had 4 to 14 migraine days each month for the last 3 months.
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I've had fewer than 15 headache days a month for the last 3 months.
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I have had migraines for over a year, starting before I was 50.
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My migraines last from 4 to 72 hours without treatment.
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I have had 4 to 14 migraine days each month for the last 3 months.
Select...
I've had fewer than 15 headache days per month for the last 3 months.
Select...
I can tell the difference between my migraine and other types of headaches.
Select...
I've tried 2-4 types of migraine prevention pills in the last 10 years without success.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 to 12 of dbt phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 to 12 of dbt phase for reporting.

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 (75 mg) to placebo

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
~12670

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,818 Total Patients Enrolled
13 Trials studying Migraine
18,857 Patients Enrolled for Migraine
PfizerLead Sponsor
4,545 Previous Clinical Trials
11,422,228 Total Patients Enrolled
22 Trials studying Migraine
24,221 Patients Enrolled for Migraine
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,457 Previous Clinical Trials
8,603,698 Total Patients Enrolled
17 Trials studying Migraine
17,748 Patients Enrolled for Migraine

Media Library

Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05518123 — Phase 4
Migraine Research Study Groups: Rimegepant 75 mg, Placebo
Migraine Clinical Trial 2023: Rimegepant Highlights & Side Effects. Trial Name: NCT05518123 — Phase 4
Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518123 — Phase 4
Migraine Patient Testimony for trial: Trial Name: NCT05518123 — Phase 4

Frequently Asked Questions

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

What is the current sample size of participants in this research trial?

"The study's sponsor, Biohaven Pharmaceuticals Inc., requires 600 patients who meet their inclusion criteria to conduct the trial. Multiple sites will be employed for this purpose, including DM Clinical Research in Tomball Texas and Northwest Clinical Research Centre in Bellevue Washington."

Answered by AI

Who meets the eligibility criteria for this clinical experiment?

"This clinical trial seeks 600 persons aged 18-65 who are suffering from migraines. For eligibility, applicants must have dealt with migraine episodes for at least one year prior to turning 50 years old; the length of headache bouts should range between 4 and 72 hours if not medicated; on average, there should be between four and fourteen days per month where migraine is experienced in the three months before screening; no more than fifteen headaches a month (migraine or otherwise) during those same three months and throughout the duration of the screening period is allowed; participants need to distinguish their migraine attacks from tension/cluster headaches as well as demonstrate"

Answered by AI

How many settings are being monitored to oversee the progress of this trial?

"This clinical trial is taking place in 18 locations across the country, including Tomball, Bellevue and Miami. To reduce stress on participants, it's recommended to select a nearby center when enrolling."

Answered by AI

What potential adverse effects should be taken into consideration when prescribing Rimegepant 75 mg?

"The safety of Rimegepant 75mg is highly rated, attaining a score of 3 due to its Phase 4 status which confirms the drug's approval."

Answered by AI

Are there vacancies open for participation in this experiment?

"The details on clinicaltrials.gov confirm that the recruitment of this medical trial is currently underway, having been initially posted to the website at the start of November 7th 2022 and subsequently updated a day later."

Answered by AI

Can individuals under the age of 40 partake in this research project?

"Patients should be between 18 and 65 years old to qualify for this clinical trial. There are 32 trials that provide medical treatments specifically designed for minors, while 117 studies focus on patients over the age of seniority."

Answered by AI

Who else is applying?

What state do they live in?
California
Tennessee
What site did they apply to?
California Neuroscience Research, LLC
AppleMed Research Group, LLC
Other
Headache Wellness Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

getting relief for them migraines and the money from the trial. Am always looking for news medications to help when I get a migraine as it is so painful.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How responsive is this trial?

Most responsive sites:
  1. California Neuroscience Research, LLC: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Phone Call
~244 spots leftby Feb 2025