RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT06995729

Registry updated: 2026-09-28

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Description

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.

Interventions

Zavegepant (Drug)
Zavegepant 5 mg or 10 mg (dose is weight-dependent)

Eligibility criteria

Inclusion Criteria: 1. Participants aged 6 years to less than 12 years. 2. Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit. 3. Weight \>15 kg at the Screening Visit Exclusion Criteria: 1. Evidence or history of clinically significant disease. 2. Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. 3. Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome. 4. Conditions that may affect the administration or absorption of the nasal product 5. 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) 6. Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN 7. Abnormal ECG (Electrocardiogram) at screening visit

Conditions

Acute Treatment of Migraine

Locations

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
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Central States Research — Tulsa, Oklahoma, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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