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
Antonios Likourezos
Summary
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.
Description
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 ED of Maimonides Medical Center with acute migraine headache. The investigators will conduct the study in the emergency department of Maimonides Medical Center, an urban emergency department that receives over 120,000 adult visits annually. The emergency department is staffed on weekdays by salaried, trained, bilingual (English and Spanish) research associates who execute research studies u…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 breast…
Interventions
- DrugRimegepant
NURTEC ODT 75 mg orally disintegrating tablets
- DrugRizatriptan Benzoate
Rizatriptan ODT 10mg orally disintegrating tablets
Location
- Maimonides Medical CenterBrooklyn, New York