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
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.
Exclusion Criteria:
Any psychiatric condition that is uncontrolled and/or untreated, including:
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
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.
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