Are migraine attacks impacting your quality of life?
The THRIVE Trial is now enrolling participants
People who take part may receive*:
- Trial-related care from local doctors at no cost
- Trial medication at no cost
There is no obligation to participate, so see if you qualify now.
THRIVE — Exploring migraine prevention
What is the THRIVE Trial?
Migraine is a debilitating condition that affects millions of people in the United States each year. Often characterized as a severe, disabling headache, migraine can impact a person’s quality of life and ability to work.
Currently, there are several different types of FDA-approved medications to help prevent migraine. One type of approved medication is calcitonin gene-related peptide (CGRP)-targeting medications. CGRP is a protein found in the body that is thought to play a role in migraine.
- The THRIVE Trial is a Phase 4 clinical trial (also called a “clinical research study”) that is looking into whether the trial drug, which is a CGRP-targeting medication that is FDA-approved to help prevent migraine, will:
- work to prevent migraine in adults for whom similar medications did not work well
- affect participants’ ability to carry out daily activities.
Approximately 150 adults in the US will take part in this clinical trial.
What to expect?
If you join the trial, you will need to visit the trial center, have phone calls with the trial team, and have tests and assessments to monitor your health. These will include:
- questionnaires and interviews about your medical history
- questions about your current and past medications
- physical examinations
- checking your vital signs (blood pressure and heart rate)
- giving blood and urine samples once, at screening
- having an electrocardiogram (ECG)
- using a daily eDiary to record your migraine symptoms and treatments
- pregnancy tests if you are able to get pregnant.
The THRIVE Trial is split into 2 periods: a screening period, and a trial treatment period.
1
Screening period
(1 month)
You will visit the study center to see if the trial is suitable for you and decide whether you want to take part.
2
Trial treatment period
(about 5.5 months)
You will visit the trial center 3 times for trial assessments and have 2 phone calls with the trial doctor. You will receive the trial drug twice during this period.
Who May Take Part?You may be eligible to participate in the THRIVE Trial if you:
are 18–75 years of age
have been diagnosed with migraine for at least 1 year
have taken a CGRP-targeting medication to prevent migraine and this medication did not work well.
There are other trial criteria that you must meet in order to take part in the THRIVE Trial.
A Phase 4 clinical research trial is conducted after the medication is approved by the FDA and made available for patients. Phase 4 trials include participants who are using approved medications. The main objective of Phase 4 clinical research trials is for researchers to check the medication’s performance in real-life scenarios, to study the long-term risks and benefits to using the medication, or to discover any rare side effect(s).
There are always risks and benefits of participating in a clinical research trial. There is always a chance that the approved medication could cause side effects or will not work. However, you should know that there are strict rules in place to monitor the safety of people taking part in a trial. Before joining any clinical research trial, it is important to consider the risks and understand them.
The trial team will explain all the risks and benefits at the first trial visit. Throughout the trial, a team of doctors and nurses will monitor the health of the people taking part. They will be there to answer any questions you may have.
Clinical research trials must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any trial.
In Phase 4 trials information about the safety of the medication has been gathered from many people over a long time. The number of participants in clinical trials starts small and increases as the phases go up from 1 to 4. This is to protect the safety of participants.
Before joining a Phase 4 clinical trial, a person must make sure they understand the benefits, such as getting access to trial-related medical care or helping others in the future. They must also understand the risks, such as unknown side effects, and how much time they will need to spend filling out diaries and attending visits. Potential trial participants can take as much time as they need to decide whether to take part and get as much information as they can. Participants can withdraw from this trial at any time.
It is a personal decision to take part. Participation in the trial is voluntary. Please also consider:
- If a decision is made to participate, the person taking part can withdraw at any time during the trial.
- The trial team will explain the possible benefits and risks of the trial during the informed consent process.
- A person does not have to join any trial if they don’t want to.
- A team of doctors and nurses will carefully monitor the health of people taking part during the trial.
- The approved medication will be provided at no cost.
- Taking part in the trial may help other people with migraine in the future.
People taking part in the clinical trial will need to follow all the instructions from the trial doctor and nurses.
See If You Pre-Qualify
