Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma

Recruiting at 14 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biohaven Pharmaceuticals, Inc.

Compensation: Varies

Number of Visits: 2

Duration: 28 days

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication for people with asthma to see if it works better than a fake treatment.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What safety data exists for Zavegepant (Zavzpret) nasal spray?

Zavegepant nasal spray is generally safe for treating migraines, but common side effects include taste disorders, nausea, nasal discomfort, and vomiting. Some people may also experience allergic reactions, and it should not be used with nasal decongestants as they can affect absorption. ^{1 2 3 4 5}

How is the drug Zavegepant different from other migraine treatments?

Zavegepant is unique because it is a nasal spray that works 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}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Inclusion Criteria

You have asthma.

Exclusion Criteria

I'm sorry, it seems that the criterion is missing. Could you please provide more information?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Zavegepant 150 mg BID or matching placebo

28 days

Daily administration

Allergen Challenge

Allergen inhalation challenge performed to assess asthmatic response

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 days

1 visit (in-person)

Treatment Details

Interventions

• Placebo
• Zavegepant

Participant Groups

Group I: BHV3500 Experimental Treatment 1 Intervention

Zavegepant 150 mg BID

Group II: Placebo Placebo Group 1 Intervention

Matching placebo 150 mg BID

Who Is Running the Clinical Trial?

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

30,100+

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

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 (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 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]

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]

References

1. 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]

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

New Nasal Spray for Migraine Headaches. [2023]

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

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

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

Zavegepant Intranasal Spray for Migraines. [2023]

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

Zavegepant: First Approval. [2023]