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Could a migraine drug stop cluster headaches? small study hints at hope

NCT ID NCT05264714

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether rimegepant (Nurtec ODT), a drug already used for migraines, could help prevent cluster headaches. Twenty adults with recurrent cluster headaches took the drug every other day for a week. Researchers measured changes in weekly attack frequency and pain severity to see if it might be a useful preventive option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rimegepant (Nurtec ODT)
What this could lead to
If it works, this could point toward a new preventive treatment for cluster headaches, reducing attack frequency.
What could go wrong
This is a very small pilot study with only 20 people, so results may not apply to everyone. It's early-stage and may not show clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

20 people

The number who actually took part.

Started

Sep 2022

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Having a diagnosis of recurrent cluster headaches, as described by ICHD-3 (International Classification of Headache Disorders-3): * Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes, when untreated. * Headache is accompanied by at least one of the following: * Ipsilateral conjunctival injection and/or lacrimation; * Ipsilateral nasal congestion and/or rhinorrhea; * Ipsilateral eyelid edema; * Ipsilateral forehead and facial sweating; * Ipsilateral miosis and/or ptosis; * A sense of restlessness or agitation. * Headache attacks occur at a frequency between every other day and 8 per day. * Headaches are not attributed to another disorder. * Subjects able to distinguish cluster headache attacks from other headache disorders, such as migraine. * Subjects on prophylactic headache medicines other than verapamil will be permitted to remain on these with possible headache-prophylactic effects if the dose is stable for at least 2 months (onabotulinumtoxinA injections stable for 6 months) prior to the screening visit and the dose is not expected to change during the course of the study. * Prior MR (magnetic resonance) imaging of head (CT if MRI contraindicated) performed after the onset of headaches. * Subjects agree to refrain from starting a new prophylactic cluster headache medicine, including steroids and nerve blocks, during the course of the study. * Subjects are required to have a cluster headache attack fre-quency ranging from one attack every other day to eight attacks per day, with at least four total attacks during the one-week prospective baseline period. Additionally, episodic cluster headache patients are required to have a history of cluster head-ache period lasting at least 6 weeks. Exclusion Criteria: * Subjects with a history of an adverse reaction to CGRP (calcitonin gene-related peptide) antibodies or another CGRP antagonist (gepant). * Subjects with episodic cluster who are felt to be toward the end of their cluster cycle (estimated to be within the last 4 weeks). * Pregnancy (negative serum pregnancy testing at enrollment and use of contraception considered to be effective). * Subjects with a history of uncontrolled, unstable, or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, or transient ischemic attack (TIA) in the 6 months prior to screening. * Subjects with other pain syndromes, psychiatric conditions, dementia or significant neurological disorders that, in the investigator's opinion might interfere with study assessments. * Use of peripheral nerve blocks (e.g., occipital, supraorbital, auriculotemporal, and/or sphenopalatine ganglion nerve blocks) one month prior to enrollment. * Use of opioids or barbiturates more than 5 days per month. * Use of other small molecule CGRP antagonist (gepant) 1 month prior to enrollment or during duration of study * Use of verapamil during the study * Use of CGRP monoclonal antibodies 3 months prior to enrollment or during duration of study. * Subjects with a secondary cluster headache related to an underlying structural etiology identified by imaging (CT or MRI).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.