RECRUITING

A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06473597

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult ED patients age 18 to 65 years old
  2. * Acute headache
  3. * Initial Pain score of 5 on a standard 11- point (score 0 to 10) numeric rating scale
  4. * Patients will have to be awake, alert, and oriented to person, place, and time
  5. * Patients able to demonstrate understanding of the informed consent process and content.
  6. * 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.
  1. * Allergy to Rimegepant or Rizatriptan
  2. * Pregnancy and breastfeeding
  3. * Unstable vital signs
  4. * Inability to provide consent
  5. * 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))
  6. * Ischemic coronary artery disease (angina pectoris, history of myocardial infarction), coronary artery vasospasm (including Prinzmetal's angina)
  7. * History of stroke or transient ischemic attack
  8. * Peripheral vascular disease
  9. * Ischemic bowel disease,
  10. * Uncontrolled hypertension
  11. * Use of another 5-HT1 agonist, ergotamine-containing medications, or ergot-type medications (methylsergide)
  12. * Hemiplegic or basilar migraine
  13. * Concurrent administration or recent discontinuation (within 2 weeks) of a MAO-A inhibitors
  14. * Current use of Rimegepant as a prophylactic
  15. * Severe Nausea and Vomiting
  16. * Severe headache requiring immediate intervention
  17. * Severe hepatic impairment
  18. * If taking any of the following medications (contraindications):
  19. * Monoaminoxidaze (MAO) inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine)
  20. * SSRI- Citalopram, Escitalopram, Sertraline
  21. * Triptans: Sumatriptan, Zolmitriptan, Imigran
  22. * Almotriptan.
  23. * Cabergoline.
  24. * Dihydroergotamine.
  25. * Dihydroergotamine intranasal
  26. * Eletriptan
  27. * Ergoloid mesylates
  28. * Ergotamine
  29. * Frovatriptan
  30. * Duloxetine
  31. * Cyclobenzaprine
  32. * Fluoxetine, velafaxine
  33. * Trazodone
  34. * Tramadol
  35. * TCA: nortriptyline (Pamelor), amitriptyline, protriptyline
  36. * Amphetamines: methamphetamine (Desoxyn), dextroamphetamine (Adderall, Adderall XR), dextroamphetamine (Dexedrine)
  37. * azole antifungals ( ketoconazole, itraconazole)
  38. * macrolide antibiotics (clarithromycin, erythromycin)
  39. * rifamycins (such as rifampin, rifabutin)
  40. * carbamazepine, phenytoin
  41. * Cardiac Drug: amiodarone (Nexterone, Pacerone), quinidine, ranolazine (Aspruzyo Sprinkle), verapamil (Verelan, Verelan PM)

Contacts and Locations

Study Contact

Sergey Motov, MD
CONTACT
718-283-6000
smotov@maimo.org
Antonios Likourezos, MPH
CONTACT
alikourezos@maimo.org

Principal Investigator

Sergey Motov, MD
PRINCIPAL_INVESTIGATOR
Maimonides Medical Center

Study Locations (Sites)

Maimonides Medical Center
Brooklyn, New York, 11219
United States

Collaborators and Investigators

Sponsor: Antonios Likourezos

  • Sergey Motov, MD, PRINCIPAL_INVESTIGATOR, Maimonides Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Migraine
  • Headache
  • Emergency Medicine

Additional Relevant MeSH Terms

  • Migraine