Status:
RECRUITING
A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
Lead Sponsor:
Pfizer
Conditions:
Acute Treatment of Migraine
Eligibility:
All Genders
6-11 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 12 2027
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06995729
Start Date
May 16 2025
End Date
August 12 2027
Last Update
July 2 2025
Active Locations (8)
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1
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States, 20016
2
Coastal Heritage Clinical Research
Hinesville, Georgia, United States, 31313
3
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
4
Accellacare - Piedmont
Statesville, North Carolina, United States, 28625