Migraine HeadachesPhase 4NCT06985342
Acute Migraine Treatment in the ED With Gepants
A Phase 4 study testing Rimegepant and Zavegepant in people with Migraine Headaches, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headaches
- What is being tested?
- Rimegepant and Zavegepant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 4 Feb 2026
- Phase
- Phase 4
- 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
- At least 18 years of age
- Capacity to provide informed consent (without a Legally Authorized Representative)
- Prior migraine diagnosis (clinical or self-reported)
- Emergency Department presentation for a headache fulfilling International Classification of Headache Disorders (ICHD-3) criteria for migraine with typical aura or without aura, or criteria for probable migraine with typical aura or without aura. Duration of migraines should be ≥ 1 year. It is acceptable if current headache duration is >72 hours. Must have been headache free for >48 hours prior to current attack.
- Willingness to participate in post-discharge telephone or electronic follow-up assessments
Who cannot join
- Suspected secondary headache due to another cause, or primary headache disorder other than migraine or probable migraine
- Prior healthcare encounter for headache within 7 days
- Use of analgesics or abortive headache medications within 2 hours of consent
- Use of intranasal decongestant within 12 hours of consent
- Use of the following drug/food categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors/inducers, 5) NTCP transporter potent inhibitors/inducers
- History of cardiovascular disease, hypertension, or diabetes, recently diagnosed or currently uncontrolled or unstable
Show all 14Show fewer
- History of stroke, peripheral vascular disease, or medically-diagnosed Raynaud's Phenomenon
- History of severe hepatic impairment, as assessed by the investigator or qualified delegate
- History of kidney disease stage 4 (creatinine clearance <30 mL/min or eGFR <35 mL/min/1.73 m2)
- History of nasal condition that may affect zavegepant administration, as assessed by the investigator or qualified delegate
- History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients
- Lifetime use of CGRP-targeting acute or preventive migraine medications
- In custody of law enforcement
- Current pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-Label Study Examining the Use of Rimegepant ODT 75 mg or Zavegepant Nasal Spray 10 mg for Acute Treatment of Migraine in the Emergency Department Setting
This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Although these two calcitonin gene-related peptide receptors (CGRP) receptor antagonists are FDA-approved for the indication of acute migraine treatment, past studies have been limited to the outpatient setting. If these medications are effective in the Emergency Department, their delivery methods alone may have advantages over intravenous medications commonly used for acute migraine in EDs, including quicker time to treatment delivery, faster pain relief, and reduced ED length of stay. This investigation is a pilot study to examine rimegepant and zavegepant in an ED, to gain insight on effectiveness in this setting.
This study will administer rimegepant 75 mg ODT single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments to 100 patients in the Emergency Department. It is a single center, open-label, non-controlled 2-group clinical trial (allocated 1:1 to rimegepant or zavegepant via pseudo-random assignment). The study will enroll adults in the ED meeting ICHD-3 criteria for migraine or probable migraine, with or without aura.
- Conditions
- Migraine Headaches
- Being tested
- Rimegepant, Zavegepant
- Keywords
- Migraine, Emergency Department, Gepants, CGRP antagonists, Rimegepant, Zavegepant
- Medical subject headings
- Migraine Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Rimegepant 75 mg orally disintegrating tablet (ODT), administered as a single dose
ZavegepantDrug
Zavegepant 10 mg nasal spray, administered as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant | Experimental | Participants in this arm will receive a single dose of rimegepant 75 mg orally disintegrating tablet (ODT) for acute migraine treatment during an Emergency Department (ED) encounter. Receives: Drug: Rimegepant |
| Zavegepant | Experimental | Participants in this arm will receive a single dose of zavegepant 10 mg nasal spray for acute migraine treatment during an Emergency Department (ED) encounter. Receives: Drug: Zavegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with pain relief at 2 hours without rescue medication
Percentage of participants reporting pain as 'mild' or 'none' at 2 hours post-study drug administration, without rescue medication. Pain is categorized as none, mild, moderate, or severe.
Measured: 120 minutes (2 hours)
Secondary outcomes (2)
Percentage of participants with pain relief at 2 hours post treatment
Effectiveness of treatment measured as percentage of participants with pain relief achieving "mild" or "none" at 2 hours post-study drug administration. Pain is categorized as none, mild, moderate, or severe.
Measured: 120 minutes (2 hours) post treatment
Percentage of participants with pain relief at 60 minutes post treatment
Effectiveness of treatment measured as percentage of participants with pain relief achieving "mild" or "none" at 60 minutes post-study drug administration. Pain is categorized as none, mild, moderate, or severe.
Measured: 60 minutes post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start5 Jun 2025
- Primary completion6 Jan 2026
- Study completion4 Feb 2026
Why it stopped: Study closing at current site. Study to start as new at different site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadachesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Jonathan Schimmel, Icahn School of Medicine at Mount Sinai
- Investigators
- Jonathan Schimmel, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985342
- Sponsor's protocol ID
- STUDY-24-01677
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan does not include sharing of patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label Study Examining the Use of Rimegepant ODT 75 mg or Zavegepant Nasal Spray 10 mg for Acute Treatment of Migraine in the Emergency Department Setting
- ClinicalTrials.gov ID
- NCT06985342
- Acronym / sponsor ID
- STUDY-24-01677
- Conditions
- Migraine Headaches
- Keywords
- Migraine, Emergency Department, Gepants, CGRP antagonists, Rimegepant, Zavegepant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closing at current site. Study to start as new at different site.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 22 May 2025 (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.
This study evaluates the effectiveness of rimegepant 75 mg orally disintegrating tablet (ODT) single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments during Emergency Department (ED) encounters. Although these two calcitonin gene-related peptide receptors (CGRP) receptor antagonists are FDA-approved for the indication of acute migraine treatment, past studies have been limited to the outpatient setting. If these medications are effective in the Emergency Department, their delivery methods alone may have advantages over intravenous medications commonly used for acute migraine in EDs, including quicker time to treatment delivery, faster pain relief, and reduced ED length of stay. This investigation is a pilot study to examine rimegepant and zavegepant in an ED, to gain insight on effectiveness in this setting.
This study will administer rimegepant 75 mg ODT single-dose or zavegepant 10 mg nasal spray single-dose as acute migraine treatments to 100 patients in the Emergency Department. It is a single center, open-label, non-controlled 2-group clinical trial (allocated 1:1 to rimegepant or zavegepant via pseudo-random assignment). The study will enroll adults in the ED meeting ICHD-3 criteria for migraine or probable migraine, with or without aura.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimegepant | Experimental | Drug: RimegepantParticipants in this arm will receive a single dose of rimegepant 75 mg orally disintegrating tablet (ODT) for acute migraine treatment during an Emergency Department (ED) encounter. |
| Zavegepant | Experimental | Drug: ZavegepantParticipants in this arm will receive a single dose of zavegepant 10 mg nasal spray for acute migraine treatment during an Emergency Department (ED) encounter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Capacity to provide informed consent (without a Legally Authorized Representative)
- Prior migraine diagnosis (clinical or self-reported)
- Emergency Department presentation for a headache fulfilling International Classification of Headache Disorders (ICHD-3) criteria for migraine with typical aura or without aura, or criteria for probable migraine with typical aura or without aura. Duration of migraines should be ≥ 1 year. It is acceptable if current headache duration is >72 hours. Must have been headache free for >48 hours prior to current attack.
- Willingness to participate in post-discharge telephone or electronic follow-up assessments
Key exclusion criteria (14 listed)
- Suspected secondary headache due to another cause, or primary headache disorder other than migraine or probable migraine
- Prior healthcare encounter for headache within 7 days
- Use of analgesics or abortive headache medications within 2 hours of consent
- Use of intranasal decongestant within 12 hours of consent
- Use of the following drug/food categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors/inducers, 5) NTCP transporter potent inhibitors/inducers
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 |
|---|---|---|
| RimegepantRimegepant 75 mg orally disintegrating tablet (ODT), administered as a single dose | Drug | Rimegepant |
| ZavegepantZavegepant 10 mg nasal spray, administered as a single dose | Drug | Zavegepant |
Primary outcome
Percentage of participants with pain relief at 2 hours without rescue medication
Time frame: 120 minutes (2 hours)
Percentage of participants reporting pain as 'mild' or 'none' at 2 hours post-study drug administration, without rescue medication. Pain is categorized as none, mild, moderate, or severe.
2 secondary outcomes
Percentage of participants with pain relief at 2 hours post treatment
Time frame: 120 minutes (2 hours) post treatment
Percentage of participants with pain relief at 60 minutes post treatment
Time frame: 60 minutes post treatment
Results and safety
The study was stopped early (reason given: Study closing at current site. Study to start as new at different site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. IPD sharing plan does not include sharing of patient-level data.
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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.
Jonathan Schimmel principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rimegepant and Zavegepant in people with Migraine Headaches, run by Icahn School of Medicine at Mount Sinai 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 29 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Study closing at current site. Study to start as new at different site.). Results are not available in the source record.
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?
Percentage of participants with pain relief at 2 hours without rescue medication (time frame: 120 minutes (2 hours)). 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 29 Apr 2026.