Do you or someone that you care about suffer from migraines? Are you wondering what options you may have? Consider the PRECLUDE study – a clinical research study for patients with episodic migraines.
Migraines are headaches of moderate to severe intensity and may also include symptoms of nausea, vomiting, and sensitivity to light or sound. A patient with chronic migraine experiences headaches on 15 or more days per month. A patient with episodic migraine experiences headaches on less than 15 days per month.
We are researching an investigational study drug to understand if it could potentially help in the preventive treatment of episodic migraine in adults.
By choosing to sign up for this study, you would be helping us test the ability of an investigational study drug to prevent migraines.
About the PRECLUDE Study
This study is open to men and women between 18 and 65 years of age. To participate in this study, you must have a diagnosis of migraine and experience 6 to 14 migraine days per month.
Various screening assessments will be performed to determine if you are eligible for this study.
If you qualify and decide to take part in this study, you will be randomly assigned either an investigational study drug or a placebo. A placebo looks the same as the investigational study drug but is not expected to have any effects on the body. Neither you nor the study doctor and staff will know what treatment you are assigned to receive.
Study participants are expected to attend all visits and complete all study procedures, including:
- Investigational study drug or placebo injections during in-person study visits
- Vital signs assessments
- Physical examinations
- Blood and urine tests
- Answer daily questions about your headaches and how you are feeling using an electronic handheld device
The study will last approximately one year. In-person study visits will take place about every three months at the study site, such as a doctor’s office or the hospital. You may be reimbursed for your travel expenses. You will also receive monthly telephone calls from the site to monitor your status.
While you are involved in this research, all study-related care will be provided at no cost to you. You do not need health insurance to participate.
What is a Clinical Research Study?
A clinical research study is carefully designed medical research with human volunteers to learn more about investigational drugs. An investigational drug is a potential treatment that has not been approved for use outside of this study by national health authorities. It is not yet on the market but is allowed for use in a study to help us establish the safety and potential benefits of the investigational drug.
Volunteers for clinical research have different reasons for participating, including:
- Contributing to the advancement of science
- Access to investigational drugs
- Helping researchers find new treatments and medical care
Whatever your reasons, if you decide to participate, we will closely monitor your health and protect your privacy.
See if You Qualify for the PRECLUDE Study on Episodic Migraines
If you think the PRECLUDE study could be for you or someone you care about, please contact Olympian Clinical Research. We are available to answer any questions you may have. Your participation in this research study is voluntary. You may decide not to participate or stop participation in this study at any time without any penalty or loss of benefits to which you may otherwise be entitled.