Actively Recruiting
A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
Led by Antonios Likourezos · Updated on 2025-10-01
80
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult emergency department patients aged 18 to 65 years
- Presenting with an acute headache
- Initial pain score of 5 or higher on a standard 11-point numeric rating scale
- Awake, alert, and oriented to person, place, and time
- Able to understand and provide informed consent
- Able to describe any adverse effects experienced and express pain severity using the numeric rating scale
You will not qualify if you...
- Allergy to Rimegepant or Rizatriptan
- Pregnancy or breastfeeding
- Unstable vital signs
- Unable to provide consent
- Suspected disease other than migraine requiring emergent brain imaging or with fever above 100.4°F or neurological findings
- History of ischemic coronary artery disease, coronary artery vasospasm, stroke, transient ischemic attack, peripheral vascular disease, or ischemic bowel disease
- Uncontrolled hypertension
- Use of other 5-HT1 agonists, ergotamine-containing medications, or recent MAO-A inhibitors
- Current use of Rimegepant as a preventive treatment
- Severe nausea, vomiting, or headache requiring immediate intervention
- Severe liver impairment
- Taking contraindicated medications such as MAO inhibitors, SSRIs, triptans, certain antibiotics, antifungals, cardiac drugs, and others as listed in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
Research Team
S
Sergey Motov, MD
CONTACT
A
Antonios Likourezos, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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