A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
NCT ID: NCT06995729
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
16 participants
INTERVENTIONAL
2025-05-16
2027-08-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zavegepant
Experimental medicine under study
Zavegepant
Zavegepant 5 mg or 10 mg (dose is weight-dependent)
Interventions
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Zavegepant
Zavegepant 5 mg or 10 mg (dose is weight-dependent)
Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
11 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
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
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5301023
Identifier Type: -
Identifier Source: org_study_id
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