Acute MigrainePhase 2/3NCT04408794
Long-term Safety Study of BHV-3500 (Zavegepant*) for the Acute Treatment of Migraine
A Phase 2/3 study testing Zavegepant (BHV-3500) in people with Acute Migraine, run by Pfizer at 67 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine. BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Migraine
- What is being tested?
- Zavegepant (BHV-3500)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 974 participants
- Where
- 67 sitesUnited States
- Study dates
- 29 Jun 2020to 23 Dec 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2-8 moderate to severe migraines/month within the last 3 months
- Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting about 4-72 hours if untreated
- Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
- Ability to distinguish migraine attacks from tension/cluster headaches
- Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria
Who cannot join
- History of human immunodeficiency virus disease
- History of basilar or hemiplegic migraine
- Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
- History of nasal surgery in the 6 months preceding the screening visit
- History of gallstones or cholecystectomy
- History of gastric, or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric balloon, etcetera), or other disease or condition (for example, chronic pancreatitis, ulcerative colitis, etcetera) that causes malabsorption.
- Body mass index ≥ 33
- Hemoglobin A1c ≥6.5%
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Community Hospital of Anderson and Madison County Inc
Anderson, Indiana, 46011
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, 48104
FutureSearch Trials of Neurology
Austin, Texas, 78731
Northwest Clinical Research Center
Bellevue, Washington, 98007
Northwest Clinical Trials Inc.
Boise, Idaho, 83704
Boston Clinical Trials
Boston, Massachusetts, 02131
Crescent City Headache and Neurology Center
Chalmette, Louisiana, 70043
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
StudyMetrix Research
City of Saint Peters, Missouri, 63303
CT Clinical Research
Cromwell, Connecticut, 06416
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
iResearch Atlanta, LLC
Decatur, Georgia, 30030
OK Clinical Research LLC
Edmond, Oklahoma, 73034
Pharmacology Research Institute
Encino, California, 91316
Regional Clinical Research
Endwell, New York, 13760
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
Headache Wellness Center
Greensboro, North Carolina, 27405
PharmQuest LLC
Greensboro, North Carolina, 27408
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Clinical Investigation Specialist, Inc.
Kenosha, Wisconsin, 53144
Volunteer Research Group
Knoxville, Tennessee, 37920
eStudySite
La Mesa, California, 91942
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055
Red Star Research LLC
Lake Jackson, Texas, 77566
Dartmouth-Hitchcock Heater Road
Lebanon, New Hampshire, 03766
Synergy San Diego
Lemon Grove, California, 91945
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Pharmacology Research Institute
Los Alamitos, California, 90720
Community Clinical Research Network
Marlborough, Massachusetts, 01752
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
Coastal Clinical Research, LLC, An AMR Co.
Mobile, Alabama, 36608
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Fieve Clinical Research, Inc
New York, New York, 10017
Wr-Pri, Llc
Newport Beach, California, 92660
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32819
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236
Summit Research Network
Portland, Oregon, 97210
Collective Medical Research
Prairie Village, Kansas, 66208
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Artemis Institute for Clinical Research
San Diego, California, 92103
Artemis Institute for Clinical Research
San Marcos, California, 92078
California Medical Clinic for Headache
Santa Monica, California, 90404
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
Boston Neuro Research Center
South Dartmouth, Massachusetts, 02747
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095
Clinvest Research LLC
Springfield, Missouri, 65810
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Ki Health Partners, LLC dba New England Institute for Clinical Research
Stamford, Connecticut, 06905
Meridien Research
Tampa, Florida, 33634
Montefiore Medical Center: Headache Center
The Bronx, New York, 10461
DM Clinical Research
Tomball, Texas, 77375
Tucson Neuroscience Research
Tucson, Arizona, 85710
Preferred Primary Care Physicians, Inc.
Union, Pennsylvania, 15401
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454
Medvadis Research Corporation
Waltham, Massachusetts, 02451
Wilmington Health, PLLC
Wilmington, North Carolina, 28401
Tekton Research, Inc.
Yukon, Oklahoma, 73099
About this study
Official title: A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine
The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine.
- BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.
- Conditions
- Acute Migraine
- Being tested
- Zavegepant (BHV-3500)
- Keywords
- migraine, headache, intranasal
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zavegepant (BHV-3500)Drug
Also called Vazegepant
10 mg IN up to 8 times per month, up to 1 year
| Study group | Role | What they receive |
|---|---|---|
| Zavegepant (BHV-3500) | Experimental | 10 mg intranasal (IN) up to 8 times per month, up to 1 year Receives: Drug: Zavegepant (BHV-3500) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes.
Measured: From study drug dosing up to the end of the study (up to 52 weeks)
Number Of Participants With Clinically Significant Laboratory Abnormalities
Clinically significant laboratory abnormalities were defined as Grades 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome. Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, low-density lipoprotein (LDL)-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in to be included for a given parameter. Laboratory results were presented in US units.
Measured: From study drug dosing up to the end of the study (up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start29 Jun 2020
- Primary completion9 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408794
- Sponsor's protocol ID
- BHV3500-202
- Other IDs
- C5301029
- Status last verified
- May 2023
- First submitted
- 26 May 2020
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lipton RB, Mosher L, Fountaine RJ. Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study. Pain Ther. 2026 Feb;15(1):325-340. doi: 10.1007/s40122-025-00800-z. Epub 2025 Dec 11.
PubMed 41379282Berman G, Mullin K, Smith T, Mosher L, Sweeney S, Fountaine RJ. Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study. Headache. 2025 Jul-Aug;65(7):1180-1189. doi: 10.1111/head.14954. Epub 2025 May 20.
PubMed 40391567Mullin K, Croop R, Mosher L, Fullerton T, Madonia J, Lipton RB. Long-term safety of zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 open-label study. Cephalalgia. 2024 Aug;44(8):3331024241259456. doi: 10.1177/03331024241259456.
PubMed 39210835
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Open-label, Long-Term, Safety Trial of BHV3500 (Zavegepant*) Intranasal (IN) for the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT04408794
- Acronym / sponsor ID
- BHV3500-202
- Conditions
- Acute Migraine
- Keywords
- migraine, headache, intranasal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Posted 16 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety of BHV-3500/vazegepant intranasal in the acute treatment of migraine.
- BHV-3500, formerly "vazegepant", is now referred to as "zavegepant" (za ve' je pant). The World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee revised the name to "zavegepant" which was accepted by the United States Adopted Names (USAN ) Council for use in the U.S. and is pending formal adoption by the INN for international use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zavegepant (BHV-3500) | Experimental | Drug: Zavegepant (BHV-3500)10 mg intranasal (IN) up to 8 times per month, up to 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 2-8 moderate to severe migraines/month within the last 3 months
- Migraine attacks present for more than 1 year with age of onset of migraines prior to 50 years of age
- Migraine attacks, on average, lasting about 4-72 hours if untreated
- Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the screening visit
- Ability to distinguish migraine attacks from tension/cluster headaches
Key exclusion criteria (8 listed)
- History of human immunodeficiency virus disease
- History of basilar or hemiplegic migraine
- Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder
- History of nasal surgery in the 6 months preceding the screening visit
- History of gallstones or cholecystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zavegepant (BHV-3500)Also: Vazegepant10 mg IN up to 8 times per month, up to 1 year | Drug | Zavegepant (BHV-3500) |
Primary outcome
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation
Time frame: From study drug dosing up to the end of the study (up to 52 weeks)
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes.
Number Of Participants With Clinically Significant Laboratory Abnormalities
Time frame: From study drug dosing up to the end of the study (up to 52 weeks)
Clinically significant laboratory abnormalities were defined as Grades 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome. Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for glucose, low-density lipoprotein (LDL)-cholesterol, uric acid, and urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in to be included for a given parameter. Laboratory results were presented in US units.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41379282Lipton RB, Mosher L, Fountaine RJ. Patient-Reported Outcomes During the Acute Treatment of Migraine with Zavegepant Nasal Spray: Results from a 52-Week, Open-Label Study. Pain Ther. 2026 Feb;15(1):325-340. doi: 10.1007/s40122-025-00800-z. Epub 2025 Dec 11.
- Derived from this study: PubMed 40391567Berman G, Mullin K, Smith T, Mosher L, Sweeney S, Fountaine RJ. Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study. Headache. 2025 Jul-Aug;65(7):1180-1189. doi: 10.1111/head.14954. Epub 2025 May 20.
- Derived from this study: PubMed 39210835Mullin K, Croop R, Mosher L, Fullerton T, Madonia J, Lipton RB. Long-term safety of zavegepant nasal spray for the acute treatment of migraine: A phase 2/3 open-label study. Cephalalgia. 2024 Aug;44(8):3331024241259456. doi: 10.1177/03331024241259456.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zavegepant (BHV-3500) in people with Acute Migraine, run by Pfizer at 67 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading To Discontinuation (time frame: From study drug dosing up to the end of the study (up to 52 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04408794, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.