Recruiting

Nurtec ODT vs. Maxalt MLT-ODT

Sponsor:

Antonios Likourezos

Code:

NCT06473597

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Rimegepant

Rizatriptan Benzoate

Study Details

Brief 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.

Conditions

Migraine

Study ID

NCT06473597

Start date

Sep 1, 2024

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Rimegepant (Nurtec ODT)

Rimegepant (Nurtec ODT) 75 mg orally disintegrating tablets

active comparator: Rizatriptan Benzoate (Maxalt MLT-ODT)

Rizatriptan ODT 10mg orally disintegrating tablets

Interventions

Rimegepant

NURTEC ODT 75 mg orally disintegrating tablets

Rizatriptan Benzoate

Rizatriptan ODT 10mg orally disintegrating tablets

Primary outcome measure

  • Change in Pain Score at 60 minutes [ Time Frame: 60 minutes ]

Central Contacts and Locations

Central contacts

Sergey Motov, MD

718-283-6000smotov@maimo.org

Antonios Likourezos, MPH

alikourezos@maimo.org

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Sergey Motov, MD

smotov@maimo.org

Antonios Likourezos, MPH

alikourezos@maimo.org

More Information

Sponsor

Antonios Likourezos

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

  • Migraine
  • Headache
  • Emergency Medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Antonios Likourezos on 2025-10-01.