The RELIEF study is seeking volunteers who regularly have migraine headaches to participate in a research study.
About the RELIEF Study
The RELIEF study is evaluating an investigational drug called eptinezumab to better understand if it could be used to treat active migraine in adults who are candidates for preventative migraine therapy. “Investigational” means that the drug has not been approved by the FDA for doctors to prescribe.
The RELIEF study is testing if a single dose of eptinezumab might begin working soon after being given to the participant. Another goal of the RELIEF study is to learn more about the effectiveness and safety of eptinezumab. In addition, there is a chance that eptinezumab may have some preventative effects.
The study drug, clinic visits, laboratory tests, and procedures will be provided at no cost. You will be paid for each study visit you complete during your participation in this study. You will also be paid for your time to complete the electronic diary during the study and for returning your electronic diary at the end of the study. The study staff can tell you more about payments and how you can receive them.
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What Can I Expect if I Participate?
Study participation lasts up to about 3 months. It will involve 3 visits to the study clinic and multiple scheduled phone calls.
The study is divided into several phases:
At the first study visit, tests will be done and health information collected to see if you can join the study. If you qualify, you will begin tracking your migraine symptoms. If your migraine qualifies on the day you come in during the screening period, you will receive the study drug.
When you start to have a migraine, you will need to call the study center. If your migraine qualifies, you will come to the study center for more testing and possible study drug dosing. You should not drive yourself to and from the study center during your migraine attack. A friend or family member should drive you to and from the study clinic during your migraine attack, or other transportation may be provided. You have a 50% chance (like the flip of a coin) of receiving the investigational drug as an intravenous (IV) infusion. You could also receive a placebo (an inactive substance) as an intravenous (IV) infusion. A placebo is the best way to find out if the treatment being tested works better than receiving no treatment at all. Neither you nor the study doctor will know which treatment you receive until after the study is completed. You will need to stay at the study center for observation for about 4 hours after you receive the treatment. You may use your own rescue medication 2 hours after study drug dosing is needed, and at the discretion of your study doctor.
Approximately 1 month after you have received the study treatment, you will return to the study center for a follow-up visit to check on your health and to collect more information about your migraine headaches.
Answer a few questions to see if you qualify for the RELIEF study.
About Clinical Research
A clinical research study (also known as a clinical trial) is designed to evaluate safety and efficacy of an investigational drug in treating a specific disease or condition. The results of clinical studies help regulatory agencies like the U.S. Food and Drug Administration (FDA) decide if an investigational drug should be made available to patients. Clinical trials are the only way we can develop new and better treatments and improve patient care.
Every clinical study is reviewed by an independent review board or ethics committee, who helps ensure that the study is conducted safely and that the rights and safety of study participants are protected. Clinical studies are conducted by experienced and trained medical professionals who monitor the health of participants during the study.
Participation in the study only lasts about 3 months & requires 3 visits to the clinic