NCT06473597 · ClinicalTrials.gov record · last posted 2025-10-01
A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
StatusRecruiting
PhasePhase 4
Started2024-09-01
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from the ClinicalTrials.gov record
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.
Amendment record
3 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 3 times since 2024-06-19; most recent amendment 2025-09-30. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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2024-09-27
Status change Not Yet Recruiting→Recruitingv2
| NCT Number |
NCT06473597 |
| Lead Sponsor |
Antonios Likourezos
|
| Conditions |
Migraine |
| Enrollment |
80 participants |
| Start Date |
2024-09-01 |
| Primary Completion |
2026-12-31 (estimated) |
| Study Completion |
2026-12-31 (estimated) |
| Updated on ClinicalTrials.gov |
2025-10-01 |