Comparing two medications for treating migraine headaches in emergency patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Maimonides Medical Center
  Brooklyn, New York, United States Recruiting

Study contacts

• Principal investigator: Sergey Motov, MD — Maimonides Medical Center
• Study coordinator: Sergey Motov, MD
• Email: smotov@maimo.org
• Phone: 718-283-6000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.