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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Pfizer
Study ID
NCT06995729
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Treatment of Migraine

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Zavegepant — DRUG
    Zavegepant 5 mg or 10 mg (dose is weight-dependent)

Study Details

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.

Key Dates

Start date
May 16, 2025
Status verified
Mar 2026
Primary completion
Aug 12, 2027
Completion
Aug 12, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zavegepant
    Experimental medicine under study

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202-
Velocity Clinical Research, Washington DCWashington D.C.District of Columbia20016-
Coastal Heritage Clinical ResearchHinesvilleGeorgia31313-
Clinical Research InstituteMinneapolisMinnesota55402-
Children's Hospital & Medical CenterOmahaNebraska68114-
True North NeurologyPort Jefferson StationNew York11776-
Accellacare - PiedmontStatesvilleNorth Carolina28625-
Accellacare of Piedmont HealthCareStatesvilleNorth Carolina28625-
Accellacare US Inc.Winston-SalemNorth Carolina27103-
Central States ResearchTulsaOklahoma74136-
Cedar Health ResearchDallasTexas75251-
Granger Medical Holladay - Holladay ClinicSalt Lake CityUtah84117-
Wasatch Clinical Research, LLCSalt Lake CityUtah84107-

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital· Little Rock, ARVelocity Clinical Research, Washington DC· Washington D.C., DCCoastal Heritage Clinical Research· Hinesville, GAClinical Research Institute· Minneapolis, MNChildren's Hospital & Medical Center· Omaha, NETrue North Neurology· Port Jefferson Station, NY

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