A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
Recruiting · NCT06995729 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Inclusion criteria
- 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
Exclusion criteria
- Evidence or history of clinically significant disease.
- Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- 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)
- Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN
- Abnormal ECG (Electrocardiogram) at screening visit
Where it is running
13 locations listed across 10 US states.
- 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