Migraine can be a debilitating condition for young people. If you are exploring options, we invite you to learn more.

This clinical trial will help doctors, scientists, & migraine specialists learn if the study medicine (called rimegepant) can prevent migraine in children and teens (aged 6 to 17). The study medicine is taken by mouth and dissolves under the tongue. 

Participants in this trial will receive care from a team of dedicated medical professionals and help to advance research for children and teens who experience migraine.

This study has two phases. After completion of the first phase, if eligible, your child will receive the study medicine (rimegepant) for up to 1 year.

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 you and your child.

Your child might be able to participate in this trial if your child:

  • Is 6 to 17 years old
  • Has been diagnosed with migraine for at least 6 months by a healthcare provider
  • Experiences migraine on 6 or more days per month
  • Experiences headaches on 14 or less days per month
  • Has migraine attacks that last for 4 to 72 hours, on average, when they are not treated

 

Condition

migraine

Age

6-17 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

If you and your child choose to participate, your child will go through a screening assessment. If your child is eligible, your child will:

  • Receive all clinical trial-related care and study medicine at no charge.
  • Receive close monitoring by a trial doctor of your child’s migraine attacks and overall health.

You will:

  • Receive reimbursement for any reasonable expenses you may have as a result of your child taking part in the study such as parking, meals, or other travel-related expenses.

If the screening assessments determine your child is eligible to continue participation, your child will be randomly assigned to the study medicine or placebo. A placebo does not contain any medicine in it but looks like the medicine being studied.

After completion of the first phase of the study, your child may be eligible to participate in the second phase of the study. If your child is eligible and chooses to continue, your child will receive the study medicine (rimegepant) for up to 1 year.

Length of study treatment

First phase - up to 12 weeks/ Second phase - up to 1 year

Number of study visits

First phase - 5 clinic visits/ Second phase - 1 phone visit and 14 clinic visits

Long-term follow up

About 2 months

About Migraine

Migraine is a debilitating disorder that affects about 7.7% to 9.1% of children and increases to about 15% in adolescents. 

A Migraine is characterized by moderate to severe throbbing pain or a pulsing sensation, usually on one side of the head.  In young children, migraine pain can be on both sides of the head and may be non-throbbing. Children and adolescents with migraine may also have nausea, vomiting, blurred vision, dizziness, and fever. They may be sensitive to light, sound, strong smells, and physical activity.   

Migraine attacks can last for hours to days and the pain can be so bad that it interferes with daily activities.

About Migraine

portrait of male(s) and/or female(s) and/or child or adolescent(s) for migraine – Pfizer Clinical Trials
portrait of male(s) and/or female(s) and/or child or adolescent(s) for migraine – Pfizer Clinical Trials

The importance of representation

portrait of male(s) and/or female(s) and/or child or adolescent(s) for migraine – Pfizer Clinical Trials
portrait of male(s) and/or female(s) and/or child or adolescent(s) for migraine – Pfizer Clinical Trials

The importance of representation

The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people with migraine. Many factors, such as genetics, race, ethnicity, gender, and age, can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. Everyone needs to be represented. 

Frequently asked questions

What is the study medicine in this clinical trial?

This trial will investigate a study medicine (called rimegepant) which is thought to work by blocking pain signals in the brain.

During a migraine attack, nerve cells and blood vessels in the brain release substances that can cause pain signals. Some nerve cells contain special molecules that can detect these substances (called receptors). The study medicine is thought to work by blocking these receptors, so they cannot bind to the substances that cause pain signals.

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What is placebo?

A placebo does not contain any medicine in it but looks like the medicine being studied. It helps doctors, scientists, and migraine specialists better understand the safety and effectiveness of the medicine being studied.

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Are there any risks associated with study medicine?

All clinical trials have possible risks. The known risks of taking part in this phase 3 trial will be explained to you during the informed consent process. This happens before you and your child decide to participate. 

This study medicine has a lot of information that has already been collected during the phase 1 and 2 studies . By joining this phase 3 clinical trial your child is helping doctors, scientists, and migraine specialists better understand how well this study medicine may work in migraine for 6-17 year olds.

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What is drug development?

Drug development is the journey from an idea for a potential medicine all the way through to bringing that new medicine to patients who need it. The development process includes laboratory research and a series of clinical trials. Along the way, important information is collected about the potential medicine and how it affects clinical trial participants. If that information shows the potential medicine is safe and effective, clinical trial sponsors provide the information to regulatory authorities, which decide whether to approve the medicine’s use by patients.

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What are clinical trials?

Clinical trials (or research studies) are a type of medical research in which people volunteer to take part. Clinical trials commonly study how potential medicines and other medical treatments affect the participants. 

All medicines and vaccines that become available today for use in patients are first tested in clinical trials involving hundreds to thousands of people.

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What happens in a clinical trial?

What happens in a clinical trial depends on the ‘protocol.’ A protocol is a detailed plan that explains the purpose of the clinical trial and how it will be run. If you consider joining a clinical trial, these details will be explained to you and your child as part of the informed consent process. 

They include:

  • the length of the clinical trial
  • the study medicines, procedures, and tests in the clinical trial
  • the schedule of study activities
  • information about who can participate
  • how side effects will be tracked, managed, and reported
  • the rules that must be followed
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Who will oversee my child’s care in a clinical trial? Can I continue to see my regular medical doctor?
  • As part of a clinical trial, your child’s study-related medical care is provided by the study team at the location where you and your child are participating. This includes the principal investigator (or study doctor) — the healthcare professional who conducts and takes responsibility for the trial at that location — as well as other clinical study team members.
  • During your clinical trial, your child may also continue to see their regular medical doctors for any care that is not related to the study. It is important for you to tell your study team about other conditions your child might have, and to let them know which other doctors are caring for your child. This helps the study team coordinate your child’s overall care.
  • If your child participates, the clinical trial will provide study-related medical care, and your child’s regular medical doctors will address the other aspects of your child’s health. Your child’s regular medical doctors can also work with the study team to understand the details of the study and any impact it may have on your child’s regular medical care.
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Are clinical trials safe?

Clinical researchers must follow guidelines and regulatory requirements to help protect the rights, safety, and well-being of clinical trial participants. These include Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing and conducting clinical trials. 

There are also many entities that provide oversight of clinical trials. These include health authorities or regulators, institutional review boards and independent ethics committees, and data safety and monitoring boards.

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Who can join a clinical trial?

We encourage everybody to consider joining clinical trials. There are many types of clinical trials that study different aspects of health in people with a variety of backgrounds and conditions. Each clinical trial has its own criteria for who may participate. These are called eligibility criteria. 

Eligibility criteria include things like age, sex, overall health, type of condition, and medical treatment history. As part of the steps to join a clinical trial, the trial doctor will confirm whether your child meets all eligibility criteria and are able to participate. 

Participation in a clinical trial is always voluntary. The decision to join is personal, and it is yours.

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Is there any cost to participate in a clinical trial?

Pfizer covers the cost of the study medicines and procedures that are part of our clinical trials. 

Pfizer is also committed to reimbursing participants for reasonable clinical trial-related expenses such as transportation, parking, and meals. 

Because each study is different, we encourage you to ask the study team any questions you have. You can also refer to the informed consent document for the details about any costs for study participants and study-related reimbursement.

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