Actively Recruiting
A Phase 1, Open-Label Study to Evaluate Safety and Pharmacokinetics of Zavegepant in Children 6 to Less Than 12 Years With Migraine
Led by Pfizer · Updated on 2026-03-18
16
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and how the body processes the medicine called Zavegepant (PF-07930207) in children aged 6 to less than 12 years who have a history of migraine. The study focuses on understanding how the body changes and removes this medicine after taking it. Participants must have had migraines for at least 6 months and weigh more than 15 kilograms. All children in the study will receive a single dose of Zavegepant as a nasal spray, with the dose depending on their weight. Each participant will get one spray into one nostril. This is an open-label study, meaning everyone receives the study medicine, and the effects of different doses will be observed. The study lasts up to 10 weeks. During the study period, participants will attend 3 clinic visits and have 2 follow-up phone calls. Researchers will monitor the medicine's concentration in the blood at specific times after dosing. They will also track any side effects and changes in vital signs, lab results, and mental health. The main outcomes involve measuring how much and how quickly the medicine appears in the blood.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 6 years to less than 12 years
- Documented history of migraine with or without aura for at least 6 months before screening
- Weight greater than 15 kilograms at screening
You will not qualify if you...
- History or evidence of clinically significant disease
- Continuous migraine (unrelenting headache) within 1 month before screening
- Atypical migraine types, migraine complications, or other significant pain syndromes
- Conditions affecting nasal product administration or absorption
- Uncontrolled or untreated psychiatric conditions, including significant depression or suicidal ideation
- Serum total bilirubin greater than 1.5 times upper limit of normal or AST/ALT greater than 2 times upper limit
- Abnormal electrocardiogram at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day of dosing with follow-up assessments up to 28 days after administration
Participants receive the study medicine Zavegepant to evaluate its safety and pharmacokinetics.
1 dosing visit and several follow-up visits over 28 days
Trial Site Locations
Total: 13 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Not Yet Recruiting
2
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States, 20016
Not Yet Recruiting
3
Coastal Heritage Clinical Research
Hinesville, Georgia, United States, 31313
Actively Recruiting
4
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
Not Yet Recruiting
5
Children's Hospital & Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
6
True North Neurology
Port Jefferson Station, New York, United States, 11776
Not Yet Recruiting
7
Accellacare - Piedmont
Statesville, North Carolina, United States, 28625
Actively Recruiting
8
Accellacare of Piedmont HealthCare
Statesville, North Carolina, United States, 28625
Actively Recruiting
9
Accellacare US Inc.
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
10
Central States Research
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
11
Cedar Health Research
Dallas, Texas, United States, 75251
Actively Recruiting
12
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States, 84107
Actively Recruiting
13
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, United States, 84117
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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