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

NCT ID: NCT06995729
Registry status: Recruiting
Study type: Interventional
Phase: Phase 1
Sponsor: Pfizer
Conditions: Acute Treatment of Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 16 participants (Estimated).

What is being studied

Drug: Zavegepant

Who may be eligible

Ages: 6 Years to 11 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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

Study locations

14 study locations are listed.

Recruiting site status is explicitly provided for 14 locations; 11 are listed as Recruiting.

Countries: United States

District of Columbia, United States: 1
Georgia, United States: 1
Minnesota, United States: 1
Nebraska, United States: 1
New York, United States: 1
North Carolina, United States: 3
Ohio, United States: 1
Oklahoma, United States: 1
Pennsylvania, United States: 1
Texas, United States: 1
Utah, United States: 2

Sample of listed locations

Velocity Clinical Research, Washington DC — Washington D.C., District of Columbia, 20016, United States — Recruiting
Coastal Heritage Clinical Research — Hinesville, Georgia, 31313, United States — Recruiting
Clinical Research Institute — Minneapolis, Minnesota, 55402, United States — Recruiting
Children's Hospital & Medical Center — Omaha, Nebraska, 68114, United States — Recruiting
True North Neurology — Port Jefferson Station, New York, 11776, United States — Recruiting
Accellacare - Piedmont — Statesville, North Carolina, 28625, United States — Recruiting
Accellacare of Piedmont HealthCare — Statesville, North Carolina, 28625, United States — Recruiting
Accellacare US Inc. — Winston-Salem, North Carolina, 27103, United States — Recruiting
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, 45229, United States — Recruiting
Central States Research — Tulsa, Oklahoma, 74136, United States — Recruiting
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, 19104, United States — Recruiting
Cedar Health Research — Dallas, Texas, 75251, United States — Active, not recruiting
Granger Medical Holladay - Holladay Clinic — Salt Lake City, Utah, 84117, United States — Active, not recruiting
Wasatch Clinical Research, LLC — Salt Lake City, Utah, 84107, United States — Active, not recruiting

Study details

Start date: May 16, 2025
Primary completion date: August 12, 2027
Completion date: August 12, 2027
First posted: May 29, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06995729
Registry last updated: September 28, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT06995729 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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