NCT06995729RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 7 May 2025
- Start date
- 16 May 2025
- Primary completion date
- 12 Aug 2027
- Lead sponsor
- Pfizer
- Diseases
- Migraine
- NCT number
- NCT06995729
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 16
- From 16 May 2025 to the primary completion date, 12 Aug 2027
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
Other illness
- Evidence or history of clinically significant disease.
- Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
- Conditions that may affect the administration or absorption of the nasal product
- 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)
Lab values
- Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN
Other
- Abnormal ECG (Electrocardiogram) at screening visit
Who the study is looking for
- Participants aged 6 years to less than 12 years.
- Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
- Weight \>15 kg at the Screening Visit
Age in the registry: 6 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Cedar Health Research Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| Coastal Heritage Clinical Research Coordinator of this site? Confirm its status | Hinesville | United States | Recruiting |
| Clinical Research Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Children'S Hospital & Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| True North Neurology Coordinator of this site? Confirm its status | Port Jefferson Station | United States | Recruiting |
| Wasatch Clinical Research, LLC Coordinator of this site? Confirm its status | Salt Lake City | United States | Active, not recruiting |
| Granger Medical Holladay - Holladay Clinic Coordinator of this site? Confirm its status | Salt Lake City | United States | Active, not recruiting |
| Accellacare - Piedmont Coordinator of this site? Confirm its status | Statesville | United States | Recruiting |
| Accellacare of Piedmont HealthCare Coordinator of this site? Confirm its status | Statesville | United States | Recruiting |
| Central States Research Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
| Velocity Clinical Research, Washington DC Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Accellacare US Inc. Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.