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

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Acute Treatment of Migraine

Treatments: Drug: Zavegepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06995729

C5301023

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Zavegepant

Experimental group

Description:

Experimental medicine under study

Treatment:

Drug: Zavegepant