A Pfizer clinical trial is now enrolling children 6 to 11 years of age.

Migraine is a common and debilitating disorder in children. While leading a healthy lifestyle and avoiding triggers can help to prevent migraines, there is still a significant need for effective treatment options. 

This clinical trial will help us learn how a study medicine called zavegepant (given as a nasal spray) is processed by the body over time, and to better understand the possible benefits and risks of different doses of zavegepant in children aged 6 to 11 years. 

By participating in this trial, your child will receive care from a team of dedicated medical professionals while contributing to research that could help other children who experience migraines.

Who may participate

Joining a clinical trial is an important and personal decision. We thank you for considering participation as an option that may be right for your child. 

Your child might be able to take part in this trial if they:

  • Are 6 to 11 years of age
  • Have a history of migraine for at least 6 months
  • Weigh more than 15 kg (33 lbs.)

There are other requirements that the trial team will discuss with you.

Condition

Migraine

Age

6-11 years

Sex

Male or Female

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

What to expect

Before your child participates, you will both be given all the details about the trial, including potential benefits and risks of taking part. 

If this trial is a good fit for your child and you agree to take part, your child will receive 1 dose of the study medicine (either 5 mg or 10 mg) based on their weight. 

Your child’s participation in the trial may last up to 10 weeks, including the screening period, treatment period, study exit visit, and safety follow-up period. 

There is no cost to participate, and you do not need health insurance to take part. Additionally, you may be reimbursed for trial-related expenses such as travel, parking, and meals.

Length of study treatment

1 dose at the Day 1 visit

Number of study visits

3 in-person visits and 2 phone calls

Long-term follow up

About 28 days

About migraine

Migraine is a debilitating disorder that affects about 9% of children and adolescents.

A migraine is characterized by moderate to severe throbbing pain or a pulsing sensation, usually on one side of the head. Migraine attacks can last for hours to days and interfere with the child’s ability to participate in school and other daily activities. 

In young children, migraine pain can be on both sides of the head and may be non-throbbing. Children may experience nausea, vomiting, blurred vision, dizziness, and fever. They may also be sensitive to light, sound, strong smells, and physical activity. 

Leading a healthy lifestyle and avoiding known triggers can help to prevent migraines in children.

About migraine

Group of children at school – Pfizer Clinical Trials
Group of children at school – Pfizer Clinical Trials

Participation matters

Young girl with mother outside – Pfizer Clinical Trials
Young girl with mother outside – Pfizer Clinical Trials

Participation matters

Diversity in trial participants is important in order to understand how potential medicines work in different people. Race, ethnicity age, and sex can all impact how different people respond to the same treatment. 

When you and your child participate in a trial, you’re helping to represent both your community and all children who experience migraines. Your child’s participation could make a difference.

Frequently asked questions

What is the study medicine in this clinical trial?

The medicine being studied in this clinical trial is a nasal spray called zavegepant. Zavegepant 10 mg nasal spray has been approved by the United States Food and Drug Administration (FDA) for the treatment of migraine in adults, but it is considered investigational in this trial because it has not been approved for use in children.

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What are the possible benefits of participating in this clinical trial?

Your child may or may not directly benefit from participating in this clinical trial. However, their health will be closely monitored by the trial team, and they will be contributing to research that could help other children with migraines in the future.

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What are the potential risks of participating in this clinical trial?

The study medicine may cause side effects including nasal and/or throat irritation, unpleasant taste, nausea, vomiting, and in rare cases, allergic reaction. Blood draws may cause discomfort, bruising, bleeding, and in rare cases, infection. There may be other risks that are unknown at this time. The trial team will provide more information about the potential benefits and risks of taking part.

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Are clinical trials safe?

While all clinical trials come with some risks, participant safety is always the top priority. Clinical trials are reviewed and approved by committees responsible for protecting the rights and safety of all participants. These committees continue to regularly review the trial’s progress to ensure there are no unnecessary or excessive risks to participants.

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What if I change my mind?

Participation is your choice. You can choose to have your child leave the clinical trial at any time for any reason, and their regular medical care will not be affected.

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