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

Phase 1
Waitlist Available
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-allergen challenge on day 27) and anytime between 3 and 7 hours post-challenge on day 27

Summary

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

Eligible Conditions
  • Asthma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-allergen challenge on day 27) and anytime between 3 and 7 hours post-challenge on day 27
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-allergen challenge on day 27) and anytime between 3 and 7 hours post-challenge on day 27 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Percentage Decrease From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Any Time Between 3 and 7 Hours Post-Allergen Challenge
Secondary study objectives
Change in Methacholine PC20 From Pre-Allergen Challenge to Post-Allergen Challenge
Maximum Percentage Decrease From Baseline in FEV1 at Any Time Between 0 and 2 Hours Post-Allergen Challenge
Number of Participants With Clinically Significant Laboratory Test Abnormalities on Treatment
+1 more

Side effects data

From 2021 Phase 3 trial • 1978 Patients • NCT04571060
21%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zavegepant 10 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BHV3500Experimental Treatment1 Intervention
Zavegepant 150 mg BID
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo 150 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zavegepant
2019
Completed Phase 3
~4150

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
48 Previous Clinical Trials
37,556 Total Patients Enrolled
PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,879 Total Patients Enrolled
39 Trials studying Asthma
62,120 Patients Enrolled for Asthma
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,881 Total Patients Enrolled
16 Trials studying Asthma
1,019 Patients Enrolled for Asthma
~11 spots leftby Dec 2025
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