A Phase 1 interventional study of Zavegepant in Acute Treatment of Migraine, sponsored by Pfizer. Recruiting at 14 sites in United States. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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Among 12 studies testing zavegepant in Migraine Disorders — 4 open to participants now, 4 under way, none of them phase 3. zavegepant · Migraine Disorders.
Among the 12 studies testing zavegepant in Migraine Disorders, this one is the 9th largest by planned enrollment, is one of 3 that started in 2025, is one of 3 in phase 1, and was the 9th registered.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
Browse Migraine Disorders studies →4 of the 12 studies testing zavegepant in Migraine Disorders are open now, in 1 country. Recruiting first, the newest first:
University of South Florida · Sites in United States
Ages 18+ · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 18+
American Center for Psychiatry and Neurology
Ages 18+
By country, each count listing its studies:
zavegepant: first FDA approval 2023 (ZAVZPRET). What it is approved for, and how studies give it, is on its page →
Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.
This study: 6 Years to 11 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 3 · Phase 3 6 · Phase 4 2
First in 2019; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 16 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Median enrollment 225 across the 12 interventional studies. Of the 7 that completed or were terminated, 6 (86%) have results posted.
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8 of 12 have an industry lead sponsor. The 5 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
47 studies in Migraine Disorders by Pfizer: 10 open now, 14 under way, 6 of them phase 3. Of 30 finished, 24 (80%) have results posted.
Among the 47 studies in Migraine Disorders by Pfizer, this one is the 34th largest by planned enrollment of the 37 interventional ones that give a count, is one of 4 that started in 2025, is one of 7 in phase 1, reaches primary completion later than 3 of the 13 other live ones, and was the 41st registered.
Pfizer’s Migraine Disorders studies by the year they started, since 2007.
3 of the studies testing zavegepant in Migraine Disorders that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06401642Mayo ClinicEffectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications | 2027-03 |
| NCT07667621University of South FloridaA Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department | 2027-07 |
| NCT06995729PfizerA Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine | 2027-08-12 |
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Among the 12 studies testing zavegepant in Migraine Disorders, from their registry updates:
Among Pfizer’s 47 in Migraine Disorders:
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The purpose of the study is to learn about safety and how the body processes the study medicine called Zavegepant (PF-07930207) in children with a history of migraine. This study helps understand how the medicine is changed and removed from the body after taking it.
This study is seeking participants who:
All participants in this study will receive zavegepant as a nasal spray once (one spray into one nostril). The dose of the study medicine that each participant receives will depend on how much the participant weighs.
The study will look at the experiences of the participants receiving the study medicine and collect data to better understand the possible benefits and unwanted effects of different doses of the study medicine.
Participants will take part in this study for up to 10 weeks. During this time, they will have 3 study visits at the study clinic, and 2 follow-up phone calls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any psychiatric condition that is uncontrolled and/or untreated, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental medicine under study
Drug: Zavegepant
Zavegepant 5 mg or 10 mg (dose is weight-dependent)
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration of zavegepant after administration of a single dose
Time frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax is defined as the time to reach maximum observed plasma concentration
Time frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Area Under the Curve From Time Zero to infinity.
AUC (0 - inf) is defined as area under the concentration-time curve from time 0 to infinity.
Time frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Number of Participants with All-Causality Treatment-emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs.
Time frame: TEAE is reported from informed consent up to 28 days after administration of study drug.
Number of participants with clinically significant abnormal vital signs
Vital sign measurements include temperature, respiratory rate, pulse rate, and blood pressure.
Time frame: Assessed from screening up to 6 days after administration of study drug
Number of participants with clinically significant abnormal laboratory findings
Laboratory assessment includes hematology, chemistry and urinalysis. Clinical significance of laboratory abnormalities was judged by investigator.
Time frame: Assessed from screening up to 6 days after administration of study drug
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. The C-SSRS assessment MUST be performed by an adequately trained, certified, and delegated rater. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").
Time frame: Assessed from screening up to 6 days after administration of study drug
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Started May 2025 (actual). Primary completion is estimated for Aug 2027, 26 months after the start.
Of 39 industry-sponsored phase 1 interventional studies under Migraine Disorders, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 12. This study's planned 26 months is above that.
Counting every sponsor, half of 53 studies reached it within 6 months; a quarter within 2 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Zavegepant