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

NCT06473597 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2023-12-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

Migraine; Headache; Emergency Medicine

Outcome Measures

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.

  60 minutes

Secondary Outcomes (9)

• Change in Pain Score

  120 minutes

• Rescue Analgesia at 60 minutes

  60 minutes

• Rescue Analgesia at 120 minutes

  120 minutes

• Percentage of Patients who Sustained Headache Freedom

  24 hours

• Percentage of Patients Who Sustained Headache Relief

  24 hours

Study Arms (2)

Rimegepant (Nurtec ODT)

ACTIVE COMPARATOR

Rimegepant (Nurtec ODT) 75 mg orally disintegrating tablets

Drug: Rimegepant

Rizatriptan Benzoate (Maxalt MLT-ODT)

ACTIVE COMPARATOR

Rizatriptan ODT 10mg orally disintegrating tablets

Drug: Rizatriptan Benzoate

Interventions

Rimegepant DRUG

NURTEC ODT 75 mg orally disintegrating tablets

Also known as: Nurtec ODT

Rimegepant (Nurtec ODT)

Rizatriptan Benzoate DRUG

Rizatriptan ODT 10mg orally disintegrating tablets

Also known as: Maxalt MLT-ODT

Rizatriptan Benzoate (Maxalt MLT-ODT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients able to demonstrate understanding of the informed consent process and content.
• Patients also will have to demonstrate ability to verbalize the nature of any adverse effects they might experience as well as to express their pain severity by using the NRS.

You may not qualify if:

• Allergy to Rimegepant or Rizatriptan
• Pregnancy and breastfeeding
• Unstable vital signs
• Inability to provide consent
• Suspicion for disease process other than migraine (those requiring emergent brain imaging, with a temperature of 100.4 °F, with objective neurologic findings, secondary headache (an "organic" headache))
• Ischemic coronary artery disease (angina pectoris, history of myocardial infarction), coronary artery vasospasm (including Prinzmetal's angina)
• History of stroke or transient ischemic attack
• Peripheral vascular disease
• Ischemic bowel disease,
• Uncontrolled hypertension
• Use of another 5-HT1 agonist, ergotamine-containing medications, or ergot-type medications (methylsergide)
• Hemiplegic or basilar migraine
• Concurrent administration or recent discontinuation (within 2 weeks) of a MAO-A inhibitors
• Current use of Rimegepant as a prophylactic
• Severe Nausea and Vomiting

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

rimegepant sulfate; rizatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey Motov, MD

CONTACT

718-283-6000; smotov@maimo.org

Antonios Likourezos, MPH

CONTACT

alikourezos@maimo.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)