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A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
Sponsor: Pfizer
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.
Official title: 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
Key Details
Gender
All
Age Range
6 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2025-05-16
Completion Date
2027-08-12
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Zavegepant
Zavegepant 5 mg or 10 mg (dose is weight-dependent)
Locations (13)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States
Coastal Heritage Clinical Research
Hinesville, Georgia, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
True North Neurology
Port Jefferson Station, New York, United States
Accellacare - Piedmont
Statesville, North Carolina, United States
Accellacare of Piedmont HealthCare
Statesville, North Carolina, United States
Accellacare US Inc.
Winston-Salem, North Carolina, United States
Central States Research
Tulsa, Oklahoma, United States
Cedar Health Research
Dallas, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, United States