NCT06995729

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Treatment of Migraine

Interventions

Type	Name	Description
DRUG	Zavegepant	Zavegepant 5 mg or 10 mg (dose is weight-dependent)

Timeline

• Start date: 2025-05-16
• Primary completion: 2027-08-12
• Completion: 2027-08-12
• First posted: 2025-05-29
• Last updated: 2026-03-18

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study