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

ConditionMigraine
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAntonios Likourezos

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult ED patients age 18 to 65 years old

Acute headache

Initial Pain score of 5 on a standard 11- point (score 0 to 10) numeric rating scale

Patients will have to be awake, alert, and oriented to person, place, and time

Disqualifiers

Allergy to Rimegepant or Rizatriptan

Pregnancy and breastfeeding

Unstable vital signs

Inability to provide consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rimegepant

    Drug

    NURTEC ODT 75 mg orally disintegrating tablets

  • Rizatriptan Benzoate

    Drug

    Rizatriptan ODT 10mg orally disintegrating tablets

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Rimegepant (Nurtec ODT)Active comparator 1 intervention
Group B: Rizatriptan Benzoate (Maxalt MLT-ODT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
60 minutes

Secondary outcomes

1

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.

Time frame
120 minutes
2

Rescue Analgesia at 60 minutes

Frequency of Rescue Analgesia at 60 minutes

Time frame
60 minutes
3

Rescue Analgesia at 120 minutes

Frequency of Rescue Analgesia at 120 minutes

Time frame
120 minutes
4

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.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Antonios Likourezos

Lead sponsor

Maimonides Medical Center

Sponsor institution

Source ClinicalTrials.gov
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