NCT06473597From ClinicalTrials.govRecruiting

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

Migraine

At a glance

Phase: Phase 4
Study type: Interventional
Sponsor: Antonios Likourezos
Enrolment target: 80
Started: 1 September 2024
Main results due: 31 December 2028
Study sites: 1
Registry updated: 24 September 2026

Can you take part?

Ages 18 years to 65 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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)

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

Maimonides Medical Center
Brooklyn, New York, United States
Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06473597. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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