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RECRUITING
NCT06995729
PHASE1

A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine

Sponsor: Pfizer

View on ClinicalTrials.gov

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

Interventions

DRUG

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