What side effects are associated with this type of intervention?

Common treatments for cluster headaches include CGRP receptor antagonists like Rimegepant, triptans, and ergotamine derivatives. CGRP receptor antagonists are generally well-tolerated but can cause side effects such as nausea, fatigue, and constipation. Triptans, another common treatment, may cause dizziness, tingling, and chest discomfort. Ergotamine derivatives can lead to nausea, vomiting, and potential cardiovascular issues. It is important to discuss these options and their side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for cluster headaches, including sumatriptan and zolmitriptan, which are triptans used for acute treatment. Additionally, verapamil is commonly used as a preventive treatment. While Rimegepant, a CGRP receptor antagonist, is being studied for cluster headaches, other CGRP receptor antagonists like galcanezumab have been approved for migraine prevention but not specifically for cluster headaches. The exploration of CGRP receptor antagonists like Rimegepant represents a promising area of research for future cluster headache treatments.

What other types of research exist?

Promising novel alternatives to Rimegepant for cluster headache patients include monoclonal antibodies targeting CGRP, such as Erenumab and Fremanezumab, which have shown efficacy in migraine prevention and may offer benefits for cluster headaches. Additionally, external trigeminal neurostimulation (eTNS) devices have shown potential in acute migraine therapy and could be explored for cluster headache treatment.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week of treatment (days 1-8) for reporting.

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 • NCT05127486

Covid-19

Nasopharyngitis

Sinusitis

Nausea

Injection site pain

Fatigue

Migraine

Influenza

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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.