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

NCT06995729 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 1

Started

2025-05-16

Last updated

2026-03-18

Condition(s) studied

Acute Treatment of Migraine

Investigational drug(s) / intervention(s)

Zavegepant

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

Study 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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

11 Years

Healthy volunteers

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

Primary outcome measure(s)

Maximum Observed Plasma Concentration (Cmax) — Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Cmax is defined as the maximum observed plasma concentration of zavegepant after administration of a single dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) — Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Tmax is defined as the time to reach maximum observed plasma concentration
Area Under the Curve From Time Zero to infinity. — Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
AUC (0 - inf) is defined as area under the concentration-time curve from time 0 to infinity.

Trial sites (13)

Facility	City	Region	Status
Arkansas Children's Hospital	Little Rock	Arkansas	Not Yet Recruiting
Velocity Clinical Research, Washington DC	Washington D.C.	District of Columbia	Not Yet Recruiting
Coastal Heritage Clinical Research	Hinesville	Georgia	Recruiting
Clinical Research Institute	Minneapolis	Minnesota	Not Yet Recruiting
Children's Hospital & Medical Center	Omaha	Nebraska	Recruiting
True North Neurology	Port Jefferson Station	New York	Not Yet Recruiting
Accellacare - Piedmont	Statesville	North Carolina	Recruiting
Accellacare of Piedmont HealthCare	Statesville	North Carolina	Recruiting
Accellacare US Inc.	Winston-Salem	North Carolina	Recruiting
Central States Research	Tulsa	Oklahoma	Recruiting
Cedar Health Research	Dallas	Texas	Recruiting
Wasatch Clinical Research, LLC	Salt Lake City	Utah	Recruiting
Granger Medical Holladay - Holladay Clinic	Salt Lake City	Utah	Recruiting

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Other trials for the same condition

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine Recruiting

A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06995729 on ClinicalTrials.gov ↗ ← All trials in the USA