Clinical trial NCT06995729: A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Acute Treatment of Migraine
Keywords: migraine
zavegepant
pediatric
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
measure: Area Under the Curve From Time Zero to infinity.
timeFrame: Day 1: 0 hour, 1.25 hours, 3.5 hours; Day 2: 18 hours
Secondary outcomes:
measure: Number of Participants with All-Causality Treatment-emergent Adverse Events (TEAEs)
timeFrame: TEAE is reported from informed consent up to 28 days after administration of study drug.
measure: Number of participants with clinically significant abnormal vital signs
timeFrame: Assessed from screening up to 6 days after administration of study drug
measure: Number of participants with clinically significant abnormal laboratory findings
timeFrame: Assessed from screening up to 6 days after administration of study drug
measure: Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Assessed from screening up to 6 days after administration of study drug
Other outcomes:
Locations:
city: Washington
country: United States
facility: Velocity Clinical Research, Washington DC
state: District of Columbia
city: Hinesville
country: United States
facility: Coastal Heritage Clinical Research
state: Georgia
city: Tulsa
country: United States
facility: Central States Research
state: Oklahoma
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Salt Lake City
country: United States
facility: Granger Medical Holladay - Holladay Clinic
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: