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Calcitonin Gene-Related Peptide (CGRP) Antagonist
Rimegepant for Cluster Headache
Phase 2
Recruiting
Led By Carrie Robertson, MD
Research Sponsored by Mayo Clinic
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 baseline, week of treatment (days 1-8)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing rimegepant, a medication that may help prevent cluster headaches. It targets patients who suffer from these severe headaches, especially those who don't respond well to other treatments. Rimegepant works by blocking pain signals in the brain. It was initially approved for treating migraines and is now being studied for preventing them.
Who is the study for?
This trial is for individuals with recurrent cluster headaches not caused by another disorder. Participants must have had MR imaging to rule out other causes, experience specific symptoms like severe unilateral pain and restlessness during attacks, and have a certain frequency of headaches. They can't join if they're near the end of a cluster cycle, have recent serious heart issues or are pregnant. Those on stable doses of certain headache medicines may be eligible.
What is being tested?
The study tests rimegepant's effectiveness as a preventive treatment for cluster headaches. It aims to see if taking rimegepant reduces the frequency or severity of headache episodes in participants who meet strict criteria based on their headache patterns and associated symptoms.
What are the potential side effects?
While not explicitly stated here, common side effects from similar treatments include nausea, dizziness, dry mouth, sleepiness and potential allergic reactions. As this is an investigational study, there may be unknown risks that will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week of treatment (days 1-8)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week of treatment (days 1-8)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in weekly frequency of cluster headache attacks
Secondary study objectives
Change in daily frequency of cluster headache attacks
Change in daily headache severity
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
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cluster Headache SubjectsExperimental Treatment1 Intervention
Subjects with cluster headaches will track their headaches for a one-week baseline headache diary. After establishing the baseline headache frequency, severity, and abortive medicine use, subjects will be asked to start their first dose of rimegepant with their next moderate to severe cluster headache.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rimegepant
2021
Completed Phase 4
~12660
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cluster headache treatments often target the underlying mechanisms of pain and inflammation. Common treatments include triptans, which activate serotonin receptors to constrict blood vessels and reduce inflammation, and oxygen therapy, which increases oxygen levels in the blood to alleviate headache symptoms.
Rimegepant, a CGRP receptor antagonist, works by blocking the calcitonin gene-related peptide (CGRP) receptor, which is involved in the transmission of pain and the dilation of blood vessels. This is particularly important for cluster headache patients as CGRP levels are elevated during attacks, and blocking its action can provide significant relief from the intense pain and frequency of headaches.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,324 Previous Clinical Trials
3,059,369 Total Patients Enrolled
Carrie Robertson, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion requires that a headache is accompanied by at least one of the following:You have been diagnosed with recurrent cluster headaches according to specific guidelines.You have been experiencing cluster headaches that are likely ending within the last 4 weeks.You have had heart problems like a heart attack, heart surgery, or stroke in the past 6 months.You have other pain, mental health issues, memory problems, or serious neurological disorders that could affect the study tests, according to the doctor.You had nerve blocks in certain areas of your body in the month before joining the study.You regularly use opioids or barbiturates for more than 5 days each month.You have taken another medication for migraines in the past month or plan to take it during the study.You have taken CGRP monoclonal antibodies within 3 months before starting the study or during the study.You have cluster headaches caused by a specific problem found in imaging tests like CT or MRI.You have had a bad reaction to CGRP antibodies or another type of CGRP antagonist (gepant) in the past.People with episodic cluster headaches must have had a cluster headache period lasting at least 6 weeks in the past.Redness and tearing in one eye.You have intense, one-sided head or face pain that lasts 15 to 180 minutes when not treated.You had a brain MRI or CT scan after you started having headaches.You must have cluster headaches happening between every other day and eight times a day, with at least four attacks in the past week. If you have episodic cluster headaches, your headache periods must have lasted at least 6 weeks.You have a medical diagnosis of severe, recurring headaches that last between 15 and 180 minutes.Your headache is accompanied by specific symptoms like red eyes, runny nose, or sweating on one side of your face.You have headaches happening every other day up to 8 times a day.Your headaches are not caused by another health problem.You can tell the difference between cluster headaches and other types of headaches like migraines.If you take medicine to prevent headaches, you can still participate if the dose has been the same for at least 2 months (or 6 months for onabotulinumtoxinA injections) and it won't change during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cluster Headache Subjects
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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