A Comparison of Rimegepant Orally Disintegrating Tablet (Nurtec ODT) to Rizatriptan Benzoate Orally Disintegrating Tablet (Maxalt MLT-ODT) in Adult Patients Presenting to the ED With Migraine Headache: Randomized, Double-Blind, Clinical Trial

2023-12-20

Rimegepant (Nurtec) is an orally administered small molecule CGRP receptor antagonist with efficacy in the acute treatment of migraine. Rizatriptan benzoate (MAXALT), is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan binds with high affinity to human cloned 5-HT1B and 5-HT1D receptors which leads to activation of these receptors results in cranial vessel constriction, inhibition of neuropeptide release and reduced transmission in trigeminal pain pathways with resultant relieve of the headache. Teh investigators hypothesize that the administration of Rimegepant ODT would provide better analgesic efficacy than Rizatriptan ODT with respect to analgesic efficacy at 60 min and 120 minutes in ED patients with acute headache. This is a prospective, randomized, double-blind superiority trial evaluating and comparing analgesic efficacy and safety of Rimegepant ODT 75 mg to Rizatriptan ODT 10 mg in adult patients presenting to the Emergency Department of Maimonides Medical Center with acute migraine headache.

2024-07-01

2026-12-31

2026-12-31

Not yet recruiting

Early phase I

80

Inclusion Criteria: * Adult ED patients age 18 to 65 years old * Acute headache * Initial Pain score of 5 on a standard 11- point (score 0 to 10) numeric rating scale * Patients will have to be awake, alert, and oriented to person, place, and time * Patients able to demonstrate understanding of the informed consent process and content. * Patients also will have to demonstrate ability to verbalize the nature of any adverse effects they might experience as well as to express their pain severity by using the NRS. Exclusion Criteria: * Allergy to Rimegepant or Rizatriptan * Pregnancy and breastfeeding * Unstable vital signs * Inability to provide consent * Suspicion for disease process other than migraine (those requiring emergent brain imaging, with a temperature of 100.4 °F, with objective neurologic findings, secondary headache (an "organic" headache)) * Ischemic coronary artery disease (angina pectoris, history of myocardial infarction), coronary artery vasospasm (including Prinzmetal's angina) * History of stroke or transient ischemic attack * Peripheral vascular disease * Ischemic bowel disease, * Uncontrolled hypertension * Use of another 5-HT1 agonist, ergotamine-containing medications, or ergot-type medications (methylsergide) * Hemiplegic or basilar migraine * Concurrent administration or recent discontinuation (within 2 weeks) of a MAO-A inhibitors * Current use of Rimegepant as a prophylactic * Severe Nausea and Vomiting * Severe headache requiring immediate intervention * Severe hepatic impairment * If taking any of the following medications (contraindications): * Monoaminoxidaze (MAO) inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) * SSRI- Citalopram, Escitalopram, Sertraline * Triptans: Sumatriptan, Zolmitriptan, Imigran * Almotriptan. * Cabergoline. * Dihydroergotamine. * Dihydroergotamine intranasal * Eletriptan * Ergoloid mesylates * Ergotamine * Frovatriptan * Duloxetine * Cyclobenzaprine * Fluoxetine, velafaxine * Trazodone * Tramadol * TCA: nortriptyline (Pamelor), amitriptyline, protriptyline * Amphetamines: methamphetamine (Desoxyn), dextroamphetamine (Adderall, Adderall XR), dextroamphetamine (Dexedrine) * azole antifungals ( ketoconazole, itraconazole) * macrolide antibiotics (clarithromycin, erythromycin) * rifamycins (such as rifampin, rifabutin) * carbamazepine, phenytoin * Cardiac Drug: amiodarone (Nexterone, Pacerone), quinidine, ranolazine (Aspruzyo Sprinkle), verapamil (Verelan, Verelan PM)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-06-26