Migraine Headaches
Conditions
Keywords
Migraine, Emergency Department, Gepants, CGRP antagonists, Rimegepant, Zavegepant
Brief 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. 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.
Interventions
DRUGRimegepant
Rimegepant 75 mg orally disintegrating tablet (ODT), administered as a single dose
DRUGZavegepant
Zavegepant 10 mg nasal spray, administered as a single dose
Sponsors
Icahn School of Medicine at Mount Sinai
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with pain relief at 2 hours without rescue medication | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with pain relief at 2 hours post treatment | 120 minutes (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. |
| Percentage of participants with pain relief at 60 minutes post treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan Schimmel
Icahn School of Medicine at Mount Sinai
Outcome results
None listed