Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Participants aged 6 years to less than 12 years. 2. Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit. 3. Weight \>15 kg at the Screening Visit Who Should NOT Join This Trial: 1. Evidence or history of clinically significant disease. 2. Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. 3. Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome. 4. Conditions that may affect the administration or absorption of the nasal product 5. 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) 6. Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN 7. Abnormal ECG (Electrocardiogram) at screening visit Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Participants aged 6 years to less than 12 years. 2. Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit. 3. Weight \>15 kg at the Screening Visit Exclusion Criteria: 1. Evidence or history of clinically significant disease. 2. Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. 3. Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome. 4. Conditions that may affect the administration or absorption of the nasal product 5. 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) 6. Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN 7. Abnormal ECG (Electrocardiogram) at screening visit

Treatments Being Tested

DRUG

Zavegepant

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

Locations (13)

Arkansas Children's Hospital
Little Rock, Arkansas, United States
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States
Coastal Heritage Clinical Research
Hinesville, Georgia, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Children's Hospital & Medical Center
Omaha, Nebraska, United States
True North Neurology
Port Jefferson Station, New York, United States
Accellacare - Piedmont
Statesville, North Carolina, United States
Accellacare of Piedmont HealthCare
Statesville, North Carolina, United States
Accellacare US Inc.
Winston-Salem, North Carolina, United States
Central States Research
Tulsa, Oklahoma, United States
Cedar Health Research
Dallas, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Granger Medical Holladay - Holladay Clinic
Salt Lake City, Utah, United States