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

StatusRecruiting
PhasePhase 4
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2026 → Dec 31, 2028
See other at-risk trials from Antonios Likourezos

Record History

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  1. Primary and study completion pushed from Dec 31, 2026 to Dec 31, 2028
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 6 of 9 entries
    • Study description expanded, about 8 words
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2024 to Sep 1, 2024
    • Site details revised
    v3
  4. Secondary endpoints revised (9)
    • Study description expanded, about 1 word
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06473597
Lead Sponsor Antonios Likourezos
Conditions
(from sponsor)		 Migraine
Related terms Headache, Migraine Disorders
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov