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Clinical Trials in the USA / NCT06995729
Recruiting Phase 1

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
2026-09-28

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
No
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 (14)

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

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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2) Starting soon
A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation. Active, not recruiting
A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis Active, not recruiting
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2 Active, not recruiting

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