NCT06473597 · Antonios Likourezos
A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
What this study is about
Rimegepant (Nurtec) is an taken by mouth administered small molecule CGRP receptor antagonist with effectiveness in the acute treatment of migraine. Rizatriptan benzoate (MAXALT), is a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Ergoloid mesylates
- Frovatriptan
- Cyclobenzaprine
- Fluoxetine, velafaxine
- 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)
Where
- Brooklyn, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2025 · Source of record for eligibility and locations