The purpose of this study is to research the safety and effectiveness of a study drug for the prevention of migraine attacks in adults who experience 6-14 migraine days per month.
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.
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 investigational study drug or placebo. 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.
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.
If you think this study could be for you or someone you care about, please talk to the study doctor or staff. They are available to answer any questions you may have.
Your participation in this research study is voluntary. You may decide to not participate or stop participation in this study at any time without any penalty or loss of benefits to which you may otherwise be entitled.
Please contact the study team via the form below for further information.
You may qualify if:
- You are between the ages of 18 - 65
- You experience 6 - 14 migraine days per month
- You are not currently taking any preventative treatments
View study on ClinicalTrials.gov