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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 11
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
Velocity Clinical Research, Washington DC
NOT_YET_RECRUITING
Washington D.c.
Georgia
Coastal Heritage Clinical Research
RECRUITING
Hinesville
Minnesota
Clinical Research Institute
NOT_YET_RECRUITING
Minneapolis
North Carolina
Accellacare - Piedmont
NOT_YET_RECRUITING
Statesville
Accellacare of Piedmont HealthCare
NOT_YET_RECRUITING
Statesville
Oklahoma
Central States Research
NOT_YET_RECRUITING
Tulsa
Utah
Granger Medical Holladay - Holladay Clinic
NOT_YET_RECRUITING
Salt Lake City
Wasatch Clinical Research, LLC
NOT_YET_RECRUITING
Salt Lake City
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2027-08-12
Participants
Target number of participants: 16
Treatments
Experimental: Zavegepant
Experimental medicine under study
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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