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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
Pivotal Trial
Drug Has Already Been Approved
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
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
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
~12660
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,655 Previous Clinical Trials
17,745,658 Total Patients Enrolled
26 Trials studying Migraine
26,195 Patients Enrolled for Migraine
Biohaven Pharmaceuticals, Inc.Lead Sponsor
48 Previous Clinical Trials
36,998 Total Patients Enrolled
13 Trials studying Migraine
18,892 Patients Enrolled for Migraine
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,542 Previous Clinical Trials
14,916,834 Total Patients Enrolled
21 Trials studying Migraine
19,722 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: Rimegepant
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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
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