Comparing two medications for treating migraine headaches in emergency patients

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

This study is testing whether Rimegepant or Rizatriptan is better at relieving migraine pain in adults who come to the emergency room with severe headaches.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Maimonides Medical Center (other)
• Locations: 1 site (Brooklyn, New York)
• Trial ID: NCT06473597 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Rimegepant ODT compared to Rizatriptan ODT in adult patients presenting to the emergency department with acute migraine headaches. It is a prospective, randomized, double-blind superiority trial that aims to determine which medication provides better pain relief at 60 and 120 minutes after administration. Eligible participants are adults aged 18 to 65 with a pain score of 5 or higher on a numeric rating scale. The study is conducted at Maimonides Medical Center, which serves a large urban population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who present to the emergency department with an acute migraine headache and a pain score of 5 or higher.

Not a fit: Patients with allergies to Rimegepant or Rizatriptan, those who are pregnant or breastfeeding, or individuals with unstable vital signs will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from acute migraine headaches.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating acute migraine headaches, indicating that this trial builds on existing knowledge.

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)

Where this trial is running

Brooklyn, New York

• Maimonides Medical Center — Brooklyn, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Sergey Motov, MD — Maimonides Medical Center
• Study coordinator: Sergey Motov, MD

Conditions: Migraine, Headache, Emergency Medicine