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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Antonios Likourezos
Study ID
NCT06473597
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant — DRUG
    NURTEC ODT 75 mg orally disintegrating tablets
  • Rizatriptan Benzoate — DRUG
    Rizatriptan ODT 10mg orally disintegrating tablets

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rimegepant (Nurtec ODT)
    Rimegepant (Nurtec ODT) 75 mg orally disintegrating tablets
  • Active Comparator: Rizatriptan Benzoate (Maxalt MLT-ODT)
    Rizatriptan ODT 10mg orally disintegrating tablets

Primary Outcome Measure

Change in Pain Score at 60 minutes [ Time Frame: 60 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maimonides Medical CenterBrooklynNew York11219
Sergey Motov, MD
[email protected]
Antonios Likourezos, MPH
[email protected]

Find similar trials in Brooklyn, NY

By condition
Migraine
By specialty
Neurology
By research site
Maimonides Medical Center· Brooklyn, NY

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