RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-16
Study Completion:2027-08-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06995729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Participants aged 6 years to less than 12 years.
  2. 2. Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
  3. 3. Weight \>15 kg at the Screening Visit
  1. 1. Evidence or history of clinically significant disease.
  2. 2. Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
  3. 3. Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
  4. 4. Conditions that may affect the administration or absorption of the nasal product
  5. 5. Any psychiatric condition that is uncontrolled and/or untreated, including:
  6. * Clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70)
  7. * Suicidal ideation and behaviour (C-SSRS: any "yes" to items 2 to 5 or any "yes" to suicide behaviours)
  8. 6. Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN
  9. 7. Abnormal ECG (Electrocardiogram) at screening visit

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Velocity Clinical Research, Washington DC
Washington, District of Columbia, 20016
United States
Coastal Heritage Clinical Research
Hinesville, Georgia, 31313
United States
Central States Research
Tulsa, Oklahoma, 74136
United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
United States
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, 84117
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-16
Study Completion Date2027-08-12

Study Record Updates

Study Start Date2025-05-16
Study Completion Date2027-08-12

Terms related to this study

Keywords Provided by Researchers

  • migraine
  • zavegepant
  • pediatric

Additional Relevant MeSH Terms

  • Acute Treatment of Migraine