A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache
NCT Number: NCT06473597
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Migraine
Interventions: DRUG: Rimegepant|DRUG: Rizatriptan Benzoate
Sponsor: Antonios Likourezos
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-12-31
Locations: Maimonides Medical Center, Brooklyn, New York, 11219, United States

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.

Primary Outcome Measures: Change in Pain Score at 60 minutes, Change in Pain Score between baseline and 60 minutes. Pain score will be measured via validated an 11 point Likert Scale where 0 is no pain, 5 moderate pain and 10 very severe pain., 60 minutes
Secondary Outcome Measures: Change in Pain Score, Change in Pain Score between baseline and 120 minutes. Pain score will be measured via validated an 11 point Likert Scale where 0 is no pain, 5 moderate pain and 10 very severe pain., 120 minutes|Rescue Analgesia at 60 minutes, Frequency of Rescue Analgesia at 60 minutes, 60 minutes|Rescue Analgesia at 120 minutes, Frequency of Rescue Analgesia at 120 minutes, 120 minutes|Percentage of Patients who Sustained Headache Freedom, Sustained headache freedom, defined as achieving a level of "none" on the severe, moderate, mild, and none scale within 2 hours of investigational medication administration and maintaining this level continuously for 24 hours without use of rescue medication., 24 hours|Percentage of Patients Who Sustained Headache Relief, Sustained headache relief, defined as change within 2 hours of the patient's description of headache from severe or moderate to either mild or none without use of rescue medication, and maintaining this level of relief continuously for 24 hours., 24 hours|Percentage of Patients who had Headache Relief In the ED, Headache relief in the ED, defined as change within 2 hours of the patient's description of headache from severe or moderate to either mild or none without the use of rescue medication, 2 hours|Percentage of Patients with Headache Freedom in the ED, Headache freedom in the ED, defined as achieving a headache level of "none" within 2 hours without use of rescue medication, 2 hours|Functional Status, Achieving a normal functional status by two hours, 2 hours|Headache Medication Efficacy and Tolerability Perception by the Patient, The patient's overall assessment of efficacy and tolerability, expressed as a dichotomous response to the question "Do you want to receive the same medication the next time you visit the ER with a migraine?", 2 hours