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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Zavegepant for Migraine Prevention

Verified Trial
Phase 2 & 3
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you have at least 8 migraines a month on average?
Have you been diagnosed with chronic migraines for at least 1 year?
Must not have
Be younger than 18 years old
Screening 28 days
Treatment 52 weeks
Follow Up8 weeks
Awards & highlights

Study Summary

This trial will compare the effects of a new migraine drug to a placebo in preventing migraines.

Eligible Conditions
  • Migraine

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below


Screening ~ 28 days
Treatment ~ 52 weeks
Follow Up ~8 weeks
This trial's timeline: 28 days for screening, 52 weeks for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of zavegepant compared to placebo as a preventive treatment for migraine
Secondary outcome measures
Efficacy of zavegepant compared to placebo with the number of subjects that had a ≥ 50% reduction from Observational Phase.
Efficacy of zavegepant to placebo in the mean number of acute migraine specific medication days per month.
Efficacy of zavegepant to placebo on mean reduction from Observational Phase.
+5 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: BHV-3500 200mgActive Control1 Intervention
Zavegepant 200mg oral soft gel capsule.
Group II: BHV-3500 100mgActive Control1 Intervention
Zavegepant 100mg oral soft gel capsule.
Group III: Placebo 100mgPlacebo Group1 Intervention
Matching placebo 100mg oral soft gel capsule.
Group IV: Placebo 200mgPlacebo Group1 Intervention
Matching placebo 200mg oral soft gel capsule.

Find a Location


Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,513 Previous Clinical Trials
9,894,219 Total Patients Enrolled
22 Trials studying Migraine
23,321 Patients Enrolled for Migraine
Biohaven Pharmaceutical Holding Company Ltd.Lead Sponsor
8 Previous Clinical Trials
12,920 Total Patients Enrolled
5 Trials studying Migraine
10,447 Patients Enrolled for Migraine
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,435 Previous Clinical Trials
7,123,175 Total Patients Enrolled
17 Trials studying Migraine
16,848 Patients Enrolled for Migraine

Media Library

BHV-3500 (zavegepant) (Calcitonin Gene-Related Peptide (CGRP) Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04804033 — Phase 2 & 3
Migraine Research Study Groups: Placebo 100mg, Placebo 200mg, BHV-3500 200mg, BHV-3500 100mg
Migraine Clinical Trial 2023: BHV-3500 (zavegepant) Highlights & Side Effects. Trial Name: NCT04804033 — Phase 2 & 3
BHV-3500 (zavegepant) (Calcitonin Gene-Related Peptide (CGRP) Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804033 — Phase 2 & 3
Migraine Patient Testimony for trial: Trial Name: NCT04804033 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots left for this experiment?

"The clinicaltrials.gov website reveals that this trial is still recruiting patients. The listing for this trial was first created on March 26th, 2021 and was updated as recently as October 4th, 2022."

Answered by AI

What are the previous findings of BHV-3500 200mg?

"In 2021, BHV-3500 200mg was first studied at Hometown Urgent Care and Research. There have been 18242 completed studies since then. Presently, there are two ongoing trials; a majority of these studies are taking place in Orlando, Florida."

Answered by AI

How many patients are part of this study?

"As this clinical trial necessitates 2900 participants that meet the requirements, Biohaven Pharmaceutical Holding Company Ltd. will be carrying out the study at various locations. These include Clinical Neuroscience Solutions, Inc. dba CNS Healthcare in Orlando, Florida and Clincical Investigation Specialists, Inc. in Gurnee, Illinois, Florida and Clincical Investigation Specialists, Inc. in Gurnee, Illinois."

Answered by AI

Have there been other trials like this one before?

"There have been 2900 patients enrolled in the single trial for BHV-3500 200mg, which completed its Phase 2 & 3 stages in 2021. The study was sponsored by Biohaven Pharmaceutical Holding Company Ltd. and trials have been conducted across 97 cities in 2 countries. Since the initial trial in 2021, 18242 more have been completed."

Answered by AI

On how many different continents is this study being conducted?

"To participate in this study, please choose the location nearest you from the 98 different trial sites. Some locations include Orlando, Gurnee and Pittsburgh."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
< 18
18 - 65
What site did they apply to?
Clinical Research Center of Florida
PMG Research of Wilmington
PMG Research of Raleigh, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?

What questions have other patients asked about this trial?

How long is the study? Is this an injectable medication? What is the treatment being tested?
PatientReceived no prior treatments
Is there any injections in this and is there a trial located in Kingsport, tn?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I am on NURTEC. To try something different. I've tried several drugs none work.
PatientReceived 2+ prior treatments
I would like a cure to my migraines. Learn more about migraine treatments.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. PMG Research of Raleigh, LLC: < 24 hours
  2. Clinical Research Center of Florida: < 24 hours
  3. Accellacare of Bristol: < 24 hours
Average response time
  • < 2 Days
~853 spots leftby Dec 2027