Cluster HeadachePhase 2NCT05264714
Cluster Headache Treatment With Rimegepant
A Phase 2 study testing Rimegepant in people with Cluster Headache, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to explore the efficacy of rimegepant as a preventative therapy for cluster headache. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Rimegepant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Headache Treatment With Rimegepant-Open Label Pilot Study
The purpose of this research is to explore the efficacy of rimegepant as a preventative therapy for cluster headache.
Read the detailed description
This is a prospective, open-label pilot study to investigate the use of rimegepant for the treatment of cluster headache. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients with cluster headache will start immediately keeping track of their headaches for a one-week baseline. In contrast, patients with episodic cluster headache will be asked to contact the study coordinator at the onset of their next cluster cycle, at which point they will repeat the screening and then start their one-week baseline headache diary. After establishing the baseline headache frequency, severity, and abortive medicine use, patients will be asked to start their first dose of study drug with their next moderate to severe cluster headache. They will rate their pain for this headache on a 5 point severity scale ("no headache," "mild," "moderate," "severe" or "very severe" and rate the pain on a scale of 0 to 10 ("0" is no pain and "10" is most severe pain imaginable) at the time of taking rimegepant and rate the pain again at 15, 30, 45, and 60 minutes after taking the drug. 60 or more minutes after taking the rimegepant, they are allowed to use their usual standard of care for the acute/abortive treatment of acute cluster attacks. After this first dose, they will then take rimegepant on an every other day schedule for a total of 4 doses over 8 days. A final visit for evaluation and collection of headache diaries will be conducted at the end of the study.
- Conditions
- Cluster Headache
- Being tested
- Rimegepant
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Also called Nurtec ODT
150 mg oral disintegrating tablet every other day for one week
| Study group | Role | What they receive |
|---|---|---|
| Cluster Headache Subjects | Experimental | 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. Receives: Drug: Rimegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly frequency of cluster headache attacks
Total number of cluster headache attacks experienced in one week
Measured: Baseline, week of treatment (days 1-7)
Secondary outcomes (2)
Change in daily headache severity
Change from baseline daily headache severity in days 1 through 8 in subjects treated with rimegepant, as measured on a Numeric Pain Rating Scale (NPRS), an 11-point scale from 0 to 10, where "0" indicates no pain and "10" suggests the most severe pain imaginable
Measured: Baseline, week of treatment (days 1-8)
Change in daily frequency of cluster headache attacks
Total number of cluster headaches experienced daily
Measured: Baseline, week of treatment (days 1-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start7 Sep 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie (Beth) E. Robertson, MD, Mayo Clinic
- Investigators
- Carrie Robertson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264714
- Sponsor's protocol ID
- 21-003394
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Headache Treatment With Rimegepant-Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT05264714
- Acronym / sponsor ID
- 21-003394
- Conditions
- Cluster Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to explore the efficacy of rimegepant as a preventative therapy for cluster headache.
Detailed description
This is a prospective, open-label pilot study to investigate the use of rimegepant for the treatment of cluster headache. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients with cluster headache will start immediately keeping track of their headaches for a one-week baseline. In contrast, patients with episodic cluster headache will be asked to contact the study coordinator at the onset of their next cluster cycle, at which point they will repeat the screening and then start their one-week baseline headache diary. After establishing the baseline headache frequency, severity, and abortive medicine use, patients will be asked to start their first dose of study drug with their next moderate to severe cluster headache. They will rate their pain for this headache on a 5 point severity scale ("no headache," "mild," "moderate," "severe" or "very severe" and rate the pain on a scale of 0 to 10 ("0" is no pain and "10" is most severe pain imaginable) at the time of taking rimegepant and rate the pain again at 15, 30, 45, and 60 minutes after taking the drug. 60 or more minutes after taking the rimegepant, they are allowed to use their usual standard of care for the acute/abortive treatment of acute cluster attacks. After this first dose, they will then take rimegepant on an every other day schedule for a total of 4 doses over 8 days. A final visit for evaluation and collection of headache diaries will be conducted at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cluster Headache Subjects | Experimental | Drug: RimegepantSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Having a diagnosis of recurrent cluster headaches, as described by ICHD-3 (International Classification of Headache Disorders-3):
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RimegepantAlso: Nurtec ODT150 mg oral disintegrating tablet every other day for one week | Drug | Cluster Headache Subjects |
Primary outcome
Change in weekly frequency of cluster headache attacks
Time frame: Baseline, week of treatment (days 1-7)
Total number of cluster headache attacks experienced in one week
2 secondary outcomes
Change in daily headache severity
Time frame: Baseline, week of treatment (days 1-8)
Change in daily frequency of cluster headache attacks
Time frame: Baseline, week of treatment (days 1-8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie Robertson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rimegepant in people with Cluster Headache, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weekly frequency of cluster headache attacks (time frame: Baseline, week of treatment (days 1-7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.