A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-11
SponsorPfizer

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Zavegepant

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators