Zavegepant for Migraine

Recruiting at 1 trial location

Overseen By Todd J Schwedt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must be taking: CGRP-targeting preventives

Disqualifiers: Other primary headaches, Zavegepant allergy, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, you need to be on a stable dose of a CGRP-targeting preventive migraine medication for at least two months before starting the trial.

What data supports the effectiveness of the drug Zavegepant for treating migraines?

Research shows that Zavegepant nasal spray is effective in treating migraines, helping achieve pain relief and reducing bothersome symptoms within 2 to 48 hours. It has been approved for use in adults with acute migraines, demonstrating its effectiveness compared to standard care or placebo. ^{1 2 3 4 5}

Is Zavegepant safe for humans?

Zavegepant, also known as Zavzpret, is generally safe for treating migraines, but it can cause taste disorders, nausea, nasal discomfort, and vomiting. Some people may also experience allergic reactions. It's important to avoid using it with nasal decongestants, as they can affect how well it works. ^{1 2 3 4 5}

What makes the drug Zavegepant unique for treating migraines?

Zavegepant is unique because it is a nasal spray that acts as a CGRP receptor antagonist, providing quick relief for acute migraines. Unlike some other treatments, it is not used for prevention and should not be combined with nasal decongestants. ^{1 2 3 4 5}

What is the purpose of this trial?

Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.

Research Team

Todd Schwedt, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults who experience 2-8 migraine attacks monthly and have been on stable CGRP-targeting preventive medications for at least two months. They must meet the criteria for migraines with or without aura and can be using additional stable migraine preventives.

Inclusion Criteria

I experience 2-8 migraine attacks each month.

I suffer from migraines, whether occasionally or frequently.

I have previously used zavegepant or other gepant medications.

Exclusion Criteria

History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant

History of hypersensitivity reaction to zavegepant or to any of the components of zavegepant

I have a headache condition, but it's not migraine, except for tension-type headaches.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zavegepant to treat up to 8 migraine attacks over 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Extension

Participants receiving rimegepant for migraine prevention may continue for up to 32 consecutive weeks

32 weeks

Treatment Details

Interventions

• Zavegepant

Trial Overview The study tests Zavegepant's effectiveness in treating acute migraines among those already using other CGRP-targeting preventive treatments. It aims to understand how well Zavegepant works when taken during a migraine attack by people on these preventives.

Participant Groups

Group I: Zavegepant Treatment Experimental Treatment 1 Intervention

Participants will receive zavegepant to treat up to 8 migraine attacks over 24 weeks.

Zavegepant is already approved in United States for the following indications:

Approved in United States as Zavzpret for:

• Acute treatment of migraine with or without aura in adults

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Zavegepant (Zavzpret) is an effective nasal spray approved for treating acute migraines in adults, but it is not intended for preventive use.

Common side effects include taste disorders, nausea, nasal discomfort, and vomiting, and it should not be used with intranasal decongestants as they can reduce its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Nasal Spray for Migraine Headaches. Aschenbrenner, DS.[2023]

Zavegepant nasal spray is significantly more effective than placebo in achieving pain freedom and relief from the most bothersome symptoms of migraine within 2 hours, with odds ratios of 1.6 and 1.4 respectively.

The nasal spray also shows a higher likelihood of sustained pain freedom between 2 and 48 hours (OR = 1.74), although the difference in pain relapse rates was not statistically significant, indicating a need for further research on its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zavegepant nasal spray for the acute treatment of migraine: A meta analysis. Waqas, M., Ansari, FUR., Nazir, A., et al.[2023]

In a Phase 2/3 trial involving 1673 participants, zavegepant nasal spray at doses of 10 mg and 20 mg was found to be effective in achieving pain freedom and alleviating the most bothersome migraine symptoms within 2 hours, outperforming placebo.

The safety profile of zavegepant was favorable, with most adverse events being mild to moderate, such as dysgeusia and nausea, and no indication of serious liver toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. Croop, R., Madonia, J., Stock, DA., et al.[2023]

Zavegepant, a new CGRP receptor antagonist developed by Pfizer, was approved in March 2023 as a nasal spray for the acute treatment of migraines in adults, marking a significant advancement in migraine therapy.

An oral formulation of zavegepant is also in development, indicating ongoing efforts to provide more treatment options for individuals suffering from chronic and episodic migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zavegepant: First Approval. Dhillon, S.[2023]

In phase 2/3 trials, intranasal zavegepant at doses of 10 mg and 20 mg significantly improved pain relief and freedom from bothersome migraine symptoms compared to placebo, with 22.5% and 23.1% of patients achieving pain freedom, respectively.

Zavegepant demonstrated a safety profile similar to placebo, with common side effects including dysgeusia and nasal discomfort, making it a potentially convenient alternative to traditional migraine treatments like triptans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zavegepant Intranasal Spray for Migraines. Martirosov, AL., Giuliano, C., Shupp, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

New Nasal Spray for Migraine Headaches. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Zavegepant nasal spray for the acute treatment of migraine: A meta analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Zavegepant nasal spray for the acute treatment of migraine: A Phase 2/3 double-blind, randomized, placebo-controlled, dose-ranging trial. [2023]

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

Zavegepant: First Approval. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Zavegepant Intranasal Spray for Migraines. [2023]