Zavegepant for Migraine

Recruiting at 4 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Significant disease, Continuous migraine, Psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

16 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for children aged 6 to less than 12 years with a history of migraines for at least six months and weighing over 15 kilograms. It aims to understand how Zavegepant, given as a nasal spray, is processed by their bodies.

Inclusion Criteria

I am between 6 and 11 years old.

I weigh more than 15 kg.

I have had migraines for at least 6 months.

Exclusion Criteria

I have had constant migraines for the last month.

I have unusual migraine types or another significant pain condition.

Any psychiatric condition that is uncontrolled and/or untreated, including clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70) and suicidal ideation and behaviour (C-SSRS: any 'yes' to items 2 to 5 or any 'yes' to suicide behaviours)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of zavegepant as a nasal spray

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 follow-up phone calls

Treatment Details

Interventions

• Zavegepant

Trial Overview The study tests the safety and body's handling of Zavegepant (PF-07930207) in young migraine sufferers. Each child receives one dose via nasal spray, with the amount based on weight. Over up to 10 weeks, they'll visit the clinic three times and have two phone calls.

Participant Groups

Group I: Zavegepant Experimental Treatment 1 Intervention

Experimental medicine under study

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University