Migraines are episodic headaches that are characterized by pulsating head pain, usually occurring on one side of the head that can worsen with routine activity. These attacks may be accompanied by nausea, vomiting, an increased sensitivity to light, an increased sensitivity to sound, dizziness, blurred vision, an aura, and other symptoms.
Episodic migraine refers to attacks that occur less than 15 days per month. Both men and women experience episodic migraine headaches
What is the purpose of this research study?
The purpose of this research study is to evaluate the safety and effectiveness of an investigational drug compared with inactive placebo to see if it can prevent migraine headaches in men and women.
Who qualifies for this research study?
Potential participants are men and women ages 18 to 64 who are in good physical health and have a history of episodic migraine for more than one year. They must experience between 4 and 14 migraine days per month during the 3 months prior to the study. Potential participants must meet specific criteria before entering the research study.
How will I know if I qualify to participate in a study?
Based on some preliminary questions (regarding your age, diagnoses of migraine date of migraine diagnosis, and headache history), your study site may suggest that you schedule a visit (at the doctor’s office or clinic) for further evaluations. When you visit the doctor’s office, the study doctor and his/her team will conduct a study-related examination and tests to see if you can be enrolled in this study. If you qualify and have signed a consent form (provides complete information about the purpose of the study, its benefits and risks, and your rights as a patient), the site will inform you if you are eligible to participate at that time.
How long will my participation in the study last?
Each person’s participation may last up to approximiately 20 weeks and involve about 6 visits to the doctor’s office.
Where are the research sites?
There are approximately 20 centers nationwide that are helping to conduct these studies.
What treatments are available to me if I have a migraine?
As with any therapeutic regimen, individuals may respond differently to any available treatment. Patients should always consult with their physician prior to trying or changing any treatment regimen. Migraine attacks are typically treated with the following medications: ibuprofen, aspirin, aspirin with caffeine, and naproxen – all which are generally available without a prescription. To learn more about these medication options, please discuss them with your physician.
Will I receive the investigational drug or placebo (an active “look-alike” pill)?
If you qualify for the research study and decide to participate, you have a 50% chance of receiving the study drug and a 50% chance of receiving an inactive placebo. However, neither you nor the study doctor will know which one you are receiving.
What are the side effects of this investigational drug?
The qualified study physician will discuss the potential risks of this investigational drug with you before you begin participation in the actual study.
Does my doctor have to give his/her permission for me to participate in this study?
No, but you may contact your personal physician if you would like. You may give the study doctor permission to contact your personal physician.
For More Information, please contact:
Palm Beach Neurological Center
4520 Donald Ross Road, Suite 200
Palm Beach Gardens, Florida 33418
561-694-1010 Ext: 111