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
- Acute Treatment of Migraine
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 16
- Started
- 16 May 2025
- Main results due
- 12 August 2027
- Study sites
- 14
- Registry updated
- 28 September 2026
Can you take part?
- Ages 6 years to 11 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(14)
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States
Recruiting
Coastal Heritage Clinical Research
Hinesville, Georgia, United States
Recruiting
Clinical Research Institute
Minneapolis, Minnesota, United States
Recruiting
Children's Hospital & Medical Center
Omaha, Nebraska, United States
Recruiting
True North Neurology
Port Jefferson Station, New York, United States
Recruiting
Accellacare - Piedmont
Statesville, North Carolina, United States
Recruiting
Accellacare of Piedmont HealthCare
Statesville, North Carolina, United States
Recruiting
Accellacare US Inc.
Winston-Salem, North Carolina, United States
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Recruiting
Central States Research
Tulsa, Oklahoma, United States
Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Recruiting
Cedar Health Research
Dallas, Texas, United States
Active, not recruiting
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Active, not recruiting
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, United States
Active, not recruiting
Showing 14 of 14 sites. 11 of the 14 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06995729. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me