A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
A PHASE 1, MULTICENTER, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ZAVEGEPANT IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH HISTORY OF MIGRAINE
1 other identifier
interventional
16
1 country
13
Brief Summary
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:
- Are children aged between 6 and less than 12 years old
- Have had migraine for at least 6 months.
- Weigh more than 15 kilograms 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2025
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2025
CompletedStudy Start
First participant enrolled
May 16, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 12, 2027
March 18, 2026
March 1, 2026
2.2 years
May 7, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Observed Plasma Concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration of zavegepant after administration of a single dose
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
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.
Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Secondary Outcomes (4)
Number of Participants with All-Causality Treatment-emergent Adverse Events (TEAEs)
TEAE is reported from informed consent up to 28 days after administration of study drug.
Number of participants with clinically significant abnormal vital signs
Assessed from screening up to 6 days after administration of study drug
Number of participants with clinically significant abnormal laboratory findings
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)
Assessed from screening up to 6 days after administration of study drug
Study Arms (1)
Zavegepant
EXPERIMENTALExperimental medicine under study
Interventions
Eligibility Criteria
You may qualify if:
- Participants aged 6 years to less than 12 years.
- Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
- Weight \>15 kg at the Screening Visit
You may not qualify if:
- Evidence or history of clinically significant disease.
- Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
- Conditions that may affect the administration or absorption of the nasal product
- Any psychiatric condition that is uncontrolled and/or untreated, including:
- Clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70)
- Suicidal ideation and behaviour (C-SSRS: any "yes" to items 2 to 5 or any "yes" to suicide behaviours)
- Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN
- Abnormal ECG (Electrocardiogram) at screening visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (13)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, 20016, United States
Coastal Heritage Clinical Research
Hinesville, Georgia, 31313, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Children's Hospital & Medical Center
Omaha, Nebraska, 68114, United States
True North Neurology
Port Jefferson Station, New York, 11776, United States
Accellacare - Piedmont
Statesville, North Carolina, 28625, United States
Accellacare of Piedmont HealthCare
Statesville, North Carolina, 28625, United States
Accellacare US Inc.
Winston-Salem, North Carolina, 27103, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Cedar Health Research
Dallas, Texas, 75251, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, 84117, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2025
First Posted
May 29, 2025
Study Start
May 16, 2025
Primary Completion (Estimated)
August 12, 2027
Study Completion (Estimated)
August 12, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.