Migraine is a debilitating neurological disorder that affects about 15% of adults. A Migraine is characterized by moderate to severe throbbing pain or a pulsing sensation, usually on one side of the head. A person with migraine often has nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last for hours to days and the pain can be so bad that it interferes with your daily activities.
When home remedies and medicines have had little success, our migraine clinical trial may be an option.
This clinical trial will help us learn if the study medicine (called zavegepant) can treat migraine pain and relieve symptoms consistently across multiple migraine attacks. The study medicine is taken as a nasal spray when needed.
Throughout this trial you will receive care from a team of dedicated medical professionals.
Who may participate
Joining a clinical trial is an important and personal decision. We thank you for your considering participation as an option that may be right for you.
You might be able to participate in this trial if you:
- Are aged 18 years or older
- Have experienced migraine for more than 1 year, which started before the age of 50
- Experience migraine attacks about 3 to 8 times per month
- Have migraine attacks that last for 4 to 72 hours when they are not treated
Condition
migraine
Age
18+ 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 choose to sign the informed consent, you will go through a screening assessment to see if this study is right for you. If you are eligible, you will:
- Receive all clinical trial-related care and study medicine at no charge
- Receive close monitoring of your migraine attacks and overall health by a trial doctor
- Receive compensation for your time spent completing electronic questionnaires. You will also be reimbursement for any reasonable expenses you may have as a result of taking part in the study such as parking, meals, or other travel-related expenses
If the screening assessments determine you’re eligible to continue participating, you will be randomly assigned to one of two groups. You will receive either the study medicine only -- or you will receive 1 dose of the study medicine and 3 doses of placebo (placebo does not contain any medicine in it but looks like the medicine being studied). This means all participants are likely to receive at least 1 dose of the study medicine.
Length of study treatment
up to 20 weeks
Number of study visits
Up to 4 clinic visits and 3 phone calls
Long-term follow up
3-4 weeks
About Migraine
About Migraine
Frequently asked questions
What is the study medicine in this clinical trial?
This trial will investigate a study medicine (called zavegepant) 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 detect the substances that cause pain signals.
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
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.
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 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
A clinical trial may also have aspects such as randomisation, placebo, or blinding.
Who will oversee my care in a clinical trial? Can I continue to see my regular medical doctor?
- As part of a clinical trial, your study-related medical care is provided by the study team at the location where you’re 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, you may also continue to see your 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 you might have, and to let them know which other doctors are caring for you. This helps the study team coordinate your overall care.
- If you participate, the clinical trial will provide study-related medical care, and your regular medical doctors will address the other aspects of your health. Your 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 regular medical care.
Are clinical trials safe?
All clinical trials have possible risks. The known and unknown risks of participating in a specific study will be explained to you during the informed consent process that happens before you decide whether to participate.
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.
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 your age, sex, overall health, type of condition, and your medical treatment history. As part of the steps to join a clinical trial, the study doctor will confirm whether you meet 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.
Is there any cost to participate in a clinical trial?
Pfizer generally 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.
