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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares Nurtec ODT 75 mg with Maxalt ODT 10 mg, two tablets that dissolve in the mouth, for migraine pain relief and safety. It is for adults ages 18 to 65 with a migraine at the Maimonides Medical Center emergency department. Researchers will compare pain relief after 60 and 120 minutes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 65 years old and are a patient in the emergency department.
  • You have a current headache.
  • Your starting pain score is 5 on a scale from 0 to 10.
  • You are awake and alert, and know who you are, where you are, and the time.
  • You can understand the study and the process of agreeing to join.
  • You can describe any side effects and rate your pain on a number scale.

Who can't join

  • You are allergic to Nurtec or Maxalt, are pregnant or breastfeeding, or cannot agree to join.
  • Your vital signs, such as pulse or blood pressure, are unstable; you have severe nausea and vomiting; or your headache needs treatment right away.
  • Doctors suspect a cause other than migraine, need an urgent brain scan, find signs of a brain or nerve problem, or measure a temperature of 100.4°F.
  • You have heart disease from poor blood flow, heart artery spasms, a past stroke or mini-stroke, poor blood flow to your limbs or bowel, or uncontrolled high blood pressure.
  • You have hemiplegic migraine (with muscle weakness), basilar migraine (with brainstem-related symptoms), or severe liver problems.
  • You take Nurtec to prevent migraines, another triptan migraine drug, or an ergot-type drug.
  • You take an MAO inhibitor (a type of medicine that can treat depression and other conditions), or stopped an MAO-A inhibitor within the past 2 weeks.
  • You take any other medicine barred by the study. These include certain antidepressants, pain medicines, muscle relaxants, stimulants, antifungal drugs, antibiotics, seizure drugs, heart drugs, and cabergoline. The study team must check your exact medicines against the full list.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

NY