RecruitingPhase 4NCT06473597

A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache

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

Sponsor

Antonios Likourezos

Enrollment

80 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Migraine

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria41

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)