Nurtec ODT vs Maxalt MLT-ODT for Migraine

Overseen By Sergey Motov, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Antonios Likourezos

Must not be taking: MAO inhibitors, SSRIs, Triptans, others

Disqualifiers: Pregnancy, Stroke, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 hours

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two migraine treatments: Rimegepant (Nurtec ODT) and Rizatriptan (Maxalt), to determine which stops migraines more quickly. Both are dissolvable tablets taken orally, but they relieve headaches through different mechanisms. The study targets patients who visit the Emergency Department with severe migraines, seeking rapid pain relief. Individuals who frequently experience sudden, intense headaches and are aware of their pain levels might be suitable for this trial. As a Phase 4 trial, the treatments have already received FDA approval and proven effective, and this research aims to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including other migraine medications like triptans, some antidepressants, and specific antibiotics and antifungals. If you're on any of these, you may need to stop them before participating.

What is the safety track record for these treatments?

A previous study found rimegepant (Nurtec ODT) to be safe and well-tolerated for treating migraines. Participants took up to one dose per day over a long period, and no major liver problems occurred. Rimegepant is already approved for both immediate and preventive migraine treatments.

Research shows rizatriptan (Maxalt) effectively treats migraines, though some people may feel dizzy or sleepy after taking it. However, using it more than four times a month hasn't been fully tested for safety. Both medications have been used for migraines with some known side effects, but they are generally considered safe when used as directed. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Rimegepant (Nurtec ODT) for treating migraines because it offers a new mechanism of action compared to traditional options like triptans. Unlike triptans, which constrict blood vessels to relieve migraine symptoms, Rimegepant targets and blocks the CGRP receptor, a protein involved in migraine attacks. This provides an alternative for people who may not respond well to triptans or who cannot use them due to cardiovascular concerns. Additionally, Rimegepant comes in a convenient orally disintegrating tablet form, making it easier to take, especially during a migraine attack.

What evidence suggests that this trial's treatments could be effective for migraine?

This trial will compare Rimegepant (Nurtec ODT) with Rizatriptan (Maxalt MLT-ODT) for treating migraines. Research has shown that Rimegepant is effective, with half of the people experiencing significant pain relief within two hours. Similarly, studies have proven Rizatriptan's effectiveness, with about 49% of people experiencing relief with a 10 mg dose. Both treatments are effective, but Rimegepant might provide faster relief for some individuals. Participants in this trial will receive either Rimegepant or Rizatriptan to evaluate their effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Sergey Motov, MD

Principal Investigator

Maimonides Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patients able to demonstrate understanding of the informed consent process and content

My initial pain level is at least a 5 out of 10.

I am fully aware and can recognize people and places.

Exclusion Criteria

Allergy to Rimegepant or Rizatriptan

Pregnancy and breastfeeding

I am unable to give consent by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either Rimegepant ODT 75 mg or Rizatriptan ODT 10 mg in the ED, with pain levels assessed every 30 minutes for up to 120 minutes

2 hours

1 visit (in-person)

Follow-up

Participants are contacted by telephone 24 hours after ED discharge to ascertain headache status, satisfaction with treatment, and presence of adverse events

24 hours

1 contact (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Rimegepant
• Rizatriptan Benzoate

Trial Overview

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.

How Is the Trial Designed?

Group I: Rimegepant (Nurtec ODT) Active Control 1 Intervention

Rimegepant (Nurtec ODT) 75 mg orally disintegrating tablets

Group II: Rizatriptan Benzoate (Maxalt MLT-ODT) Active Control 1 Intervention

Rizatriptan ODT 10mg orally disintegrating tablets

Rimegepant is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Nurtec ODT for:

• Acute treatment of migraine with or without aura in adults
• Preventative treatment of episodic migraine in adults

Approved in European Union as Vydura for:

• Prophylaxis and acute treatment of migraine in adults

Approved in Canada as Nurtec ODT for:

• Acute treatment of migraine with or without aura in adults
• Preventative treatment of episodic migraine in adults

Approved in United Kingdom as Vydura for:

• Prophylaxis and acute treatment of migraine in adults

Who Is Running the Clinical Trial?

Antonios Likourezos

Lead Sponsor

Trials

41

Recruited

8,600+

Published Research Related to This Trial

Rimegepant (NURTEC ODT®) is an orally disintegrating tablet that acts as a highly-selective antagonist of calcitonin gene-related peptide, specifically designed for the acute treatment of migraines.

In February 2020, rimegepant ODT received its first global approval in the USA for treating migraines with or without aura in adults, marking a significant milestone in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant: First Approval. Scott, LJ.[2022]

Rimegepant, taken every other day, significantly reduced the mean number of migraine days per month compared to placebo, with a difference of -0.8 days, indicating its efficacy as a preventive treatment for migraines.

The safety profile of rimegepant was comparable to that of placebo, with similar rates of adverse events and no serious safety concerns reported during the study involving 747 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Croop, R., Lipton, RB., Kudrow, D., et al.[2021]

Zolmitriptan ODT (orally disintegrating tablet) is preferred by over 60% of patients compared to conventional oral sumatriptan tablets, highlighting its convenience and ease of use for acute migraine treatment.

In a comparison with rizatriptan ODT, 70% of patients favored zolmitriptan ODT for its better taste, aftertaste, and packaging, indicating it is a more appealing option for managing migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Part III: the convenience of, and patient preference for, zolmitriptan orally disintegrating tablet. Dowson, AJ., Almqvist, P.[2014]

In a study of 481 patients, rizatriptan 10-mg rapidly disintegrating tablets were preferred by nearly twice as many patients compared to sumatriptan 50-mg tablets, primarily due to faster headache relief.

Rizatriptan provided superior outcomes, with 75.9% of patients experiencing headache relief at 2 hours compared to 66.6% for sumatriptan, and a higher percentage of patients being pain-free at 2 hours (55% vs. 42.1%). Both medications were well tolerated, with similar side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of preference for rizatriptan 10-mg wafer versus sumatriptan 50-mg tablet in migraine. Pascual, J., Bussone, G., Hernandez, JF., et al.[2017]

In a study of 522 patients, rizatriptan (10 mg) was found to be more effective than naratriptan (2.5 mg) for treating migraines, providing faster headache relief as early as 30 minutes after administration.

Rizatriptan not only resulted in a higher percentage of patients being pain-free at 2 hours (44.8% vs. 20.7% for naratriptan) but also offered quicker relief from associated migraine symptoms and better overall functioning, with both treatments being well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of rizatriptan 10 mg vs. naratriptan 2.5 mg in migraine. Bomhof, M., Paz, J., Legg, N., et al.[2017]

Rimegepant is an effective treatment for migraines, showing significant pain relief and reduction in bothersome symptoms compared to placebo in phase III trials, and it can also reduce the number of monthly migraine days when used preventively.

The medication is generally well tolerated, with no signs of liver or heart-related side effects, making it a safe option for adults managing migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant: A Review in the Acute Treatment and Preventive Treatment of Migraine. Blair, HA.[2023]

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Our data confirms rimegepant effectiveness and safety in the acute migraine treatment in a real-world setting in a cohort of participants.

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Nurtec® ODT (rimegepant) | For Healthcare Professionals ^

For acute treatment at 2 hours, 21.2% of patients on Nurtec ODT (n=142/669) achieved migraine pain freedom vs 10.9% on placebo (n=74/682) (Δ10.3%*; P<0.001), ...

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The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the ...

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The safety of using more than 18 doses in a 30-day period has not been established.

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NURTEC ODT (rimegepant) - accessdata.fda.gov

The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in a randomized, double-blind, placebo-controlled trial (Study 1) in ...

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pubmed.ncbi.nlm.nih.gov

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A multicenter, open-label long-term safety study of ...

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Nurtec ODT for Patients With Migraines: Side Effects, Drug ...

Nurtec is approved for the acute treatment of migraine attacks with or without aura as well as for the preventative treatment of episodic migraines.