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

NCT ID
NCT06473597
Registry status
Recruiting
Study type
Interventional
Phase
Phase 4
Sponsor
Antonios Likourezos
Conditions
Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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

Enrollment: 80 participants (Estimated).

What is being studied

  • Drug: Rimegepant
  • Intervention: rimegepant sulfate
  • Intervention: rizatriptan
  • Drug: Rizatriptan Benzoate

Who may be eligible

Ages
18 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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)

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • Maimonides Medical Center — Brooklyn, New York, 11219, United States — Recruiting

Study details

Start date
September 1, 2024
Primary completion date
December 31, 2028
Completion date
December 31, 2028
First posted
June 25, 2024

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06473597
Registry last updated
September 24, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT06473597 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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