A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zavegepant.
- Who it may be relevant to
- Registry conditions: Acute Treatment of Migraine. Basic parameters: 6 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Zavegepant
Zavegepant 5 mg or 10 mg (dose is weight-dependent)
Primary outcome measures
- Maximum Observed Plasma Concentration (Cmax) [Time frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [Time frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours]
- Area Under the Curve From Time Zero to infinity. [Time frame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours]
Secondary outcome measures (4)
- Number of Participants with All-Causality Treatment-emergent Adverse Events (TEAEs) [Time frame: TEAE is reported from informed consent up to 28 days after administration of study drug.]
- Number of participants with clinically significant abnormal vital signs [Time frame: Assessed from screening up to 6 days after administration of study drug]
- Number of participants with clinically significant abnormal laboratory findings [Time frame: Assessed from screening up to 6 days after administration of study drug]
- Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: Assessed from screening up to 6 days after administration of study drug]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- Arkansas Children's Hospital — Little Rock
- Velocity Clinical Research, Washington DC — Washington D.C.
- Coastal Heritage Clinical Research — Hinesville
- Clinical Research Institute — Minneapolis
- Children's Hospital & Medical Center — Omaha
- True North Neurology — Port Jefferson Station
- Accellacare - Piedmont — Statesville
- Accellacare of Piedmont HealthCare — Statesville
- … and 5 more centers
Identifiers
NCT: NCT06995729 · C5301023