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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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
Cedar Health Research
Coordinator of this site? Confirm its status
DallasUnited StatesActive, not recruiting
Coastal Heritage Clinical Research
Coordinator of this site? Confirm its status
HinesvilleUnited StatesRecruiting
Clinical Research Institute
Coordinator of this site? Confirm its status
MinneapolisUnited StatesRecruiting
Children'S Hospital & Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting
Children's Hospital of Philadelphia
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
True North Neurology
Coordinator of this site? Confirm its status
Port Jefferson StationUnited StatesRecruiting
Wasatch Clinical Research, LLC
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesActive, not recruiting
Granger Medical Holladay - Holladay Clinic
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesActive, not recruiting
Accellacare - Piedmont
Coordinator of this site? Confirm its status
StatesvilleUnited StatesRecruiting
Accellacare of Piedmont HealthCare
Coordinator of this site? Confirm its status
StatesvilleUnited StatesRecruiting
Central States Research
Coordinator of this site? Confirm its status
TulsaUnited StatesRecruiting
Velocity Clinical Research, Washington DC
Coordinator of this site? Confirm its status
Washington D.C.United StatesRecruiting
Accellacare US Inc.
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.