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CGRP Receptor Antagonist

Nurtec ODT vs Maxalt MLT-ODT for Migraine

Phase 4
Recruiting
Led By Sergey Motov, MD
Research Sponsored by Antonios Likourezos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult ED patients age 18 to 65 years old
Acute headache
Must not have
Severe Nausea and Vomiting
Unstable vital signs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial aims to compare the effectiveness of two medications, Rimegepant and Rizatriptan, in treating acute migraine headaches in patients visiting the Emergency Department. The researchers believe that R

Who is the study for?
This trial is for adult emergency department patients with acute migraine headaches. Specific eligibility criteria are not provided, but typically participants must have a diagnosis of migraine and be able to take oral medication.
What is being tested?
The study is testing the effectiveness of two orally disintegrating tablets: Rimegepant (Nurtec) versus Rizatriptan (Maxalt), in providing pain relief for migraines at 60 and 120 minutes after taking the drug. It's a head-to-head comparison to see which one works better.
What are the potential side effects?
Possible side effects may include nausea, dizziness, dry mouth, fatigue, sleepiness or insomnia related to Rizatriptan; while Nurtec might cause similar symptoms along with potential allergic reactions or chest discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I am currently experiencing a severe headache.
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My initial pain level is at least a 5 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience severe nausea and vomiting.
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My vital signs are not stable.
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I am experiencing severe headaches that need immediate treatment.
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I am unable to give consent by myself.
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I have a history of heart issues, including angina or heart attack.
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I am not taking any 5-HT1 agonists, ergotamines, or similar medications.
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I am being evaluated for conditions other than migraine.
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I have had a stroke or a transient ischemic attack.
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I have peripheral vascular disease.
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I have a condition where my intestines don't get enough blood.
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My high blood pressure is not under control.
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I have a specific type of severe migraine.
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I am currently taking Rimegepant as a preventive treatment.
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I have severe liver problems.
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I am not taking any MAO inhibitors, SSRIs, Triptans, TCA, Amphetamines, certain antifungals or antibiotics, or specific cardiac drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pain Score at 60 minutes
Secondary study objectives
Change in Pain Score
Functional Status
Headache Medication Efficacy and Tolerability Perception by the Patient
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Rimegepant (Nurtec ODT)Active Control1 Intervention
Rimegepant (Nurtec ODT) 75 mg orally disintegrating tablets
Group II: Rizatriptan Benzoate (Maxalt MLT-ODT)Active Control1 Intervention
Rizatriptan ODT 10mg orally disintegrating tablets

Find a Location

Who is running the clinical trial?

Antonios LikourezosLead Sponsor
39 Previous Clinical Trials
8,374 Total Patients Enrolled
Sergey Motov, MDPrincipal InvestigatorMaimonides Medical Center
17 Previous Clinical Trials
1,515 Total Patients Enrolled
~53 spots leftby Dec 2026
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