Do you suffer from migraine headaches on a regular basis?

If the answer is yes, then you might be able to participate in a local research study.

About Migraine Headaches

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Migraine affects 39 million Americans and is considered the 6th most disabling disease in the world. * 
It is a disease of the nervous system that results in repeated episodes of:

  • moderate-to-severe headaches
  • nausea and vomiting
  • sensitivities to light and sound

It’s hard to predict when a migraine will occur, they can have a profound impact on daily life.

The medical community has yet to discover exactly what causes migraine attacks, but common migraine triggers include stress or fatigue, bright lights, strong smells, and certain foods. These triggers appear to cause changes in certain body chemicals that cause blood vessels to constrict, leading to sensitivity and pain.

Additional treatments are badly needed to help migraine sufferers.

Your participation could help advance research.

*Source: Migraine Research Foundation. (2019) Raising Money for MIGRAINE RESEARCH. Retrieved from https://migraineresearchfoundation.org/about-migraine/migraine-facts/

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.

Migraine Study 2

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.

Together we can better understand
migraine headaches

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: 

1: Screening Period
Up to 2 months

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. 

2: Study Treatment
When a migraine occurs

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.

3: Follow-up Visit
One month after receiving the study treatment

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

Why Participate in this Clinical Research Study?

Participation may result in an improvement of symptoms or disease, or no improvement at all. It is also possible that some participants may feel worse. However, there are benefits to participating in this clinical study:

  • Helping to advance the research of new, alternative, or better migraine treatments
  • Receiving care and monitoring from specialized medical professionals, treatment for the medical condition being evaluated, and medical supplies at no cost 

Taking part in a clinical trial is completely voluntary. Participation is not required, and if enrolled in a clinical study, you can choose to end participation at any time and for any reason. 

Your participation in the RELIEF study may help us gather valuable information about the investigational medication and the treatment migraines.

Frequently Asked Questions

You will be paid for each study visit you complete, for completing the electronic diary during the study, and for returning your electronic diary at the end of the study. Transportation will be available to and from the clinic on the day you receive study drug. The study drug, clinic visits, laboratory tests, and procedures are provided at no cost.

The investigational drug being tested in this study is called eptinezumab. It is being tested to see if it might be safe and effective for treating active migraine in adults who are candidates for preventive migraine therapy. It’s administered as an intravenous (IV) infusion over approximately 30 to 45 minutes. 

Study tests and procedures include:

  • Blood and urine samples
  • Physical exam and vital signs
  • Electrocardiogram (ECG)
  • Questionnaires and migraine assessments
  • Medical history
  • Keeping track of your migraine symptoms with an electronic diary (a device like a smartphone)

You may qualify to participate if you:

  • Are 18 to 75 years of age
  • Have moderate to severe migraine headaches

Take part in migraine research. Get started now

You have the right to ask any questions at any time as part of the study participation experience. Some examples include:

  • What are the risks and benefits?
  • What is expected of participants?
  • How long does the study last?
  • What should I expect at study visits?

Informed Consent is a process to help explain the details of the study, including the potential risks and benefits, your rights and responsibilities, and possible side effects. 

Participation is completely voluntary. Participants can decide to stop at any time for any reason, even after the Informed Consent form is signed.

A placebo looks like the investigational drug, but it doesn’t have any active ingredients. In placebo-controlled research studies, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.

No. You will be randomly assigned to receive either the investigational drug or a placebo. Neither you nor the study doctor will know which treatment you receive until after the study is completed. 

Every clinical study is reviewed and monitored by an Institutional Review Board (IRB) which helps ensure that the study is conducted safely and that the rights, privacy, and safety of study participants are protected. IRBs are made up of medical professionals, scientists, and members of the community.

Participation is voluntary. You can withdraw from the study at any time and for any reason, even after you’ve signed the Informed Consent form. The study doctor may still need to check your health after you stop the study.

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