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?

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.

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.

How does the drug Rimegepant differ from other migraine treatments?

Rimegepant is unique because it is the first drug approved for both the acute treatment and prevention of migraines, and it comes as an orally disintegrating tablet (ODT) that dissolves on the tongue, offering convenience and potentially faster relief compared to conventional tablets. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Rimegepant (Nurtec ODT) for treating migraines?

Rimegepant, available as an orally disintegrating tablet, has been shown to be more effective than a placebo in relieving pain and reducing the number of migraine days in adults, both for immediate relief and long-term prevention. It is well tolerated and does not show harmful effects on the liver or heart. ^{1 2 3 4 6}

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

I experience severe nausea and vomiting.

Pregnancy and breastfeeding

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]

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, 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]

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]

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]

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]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Rimegepant: First Approval. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of rizatriptan 10 mg vs. naratriptan 2.5 mg in migraine. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of preference for rizatriptan 10-mg wafer versus sumatriptan 50-mg tablet in migraine. [2017]

6. England pubmed.ncbi.nlm.nih.gov

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