IRB Number:

1475-03

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

The purpose of this research study is to determine if there are enough patients with hard to treat epilepsy that might qualify for a future study of a medical device that is being developed to treat epilepsy. Participants will not be testing the device during this study. The study doctor will be assessing seizure type(s) and determine how frequently they occur, and to verify if antiseizure medications can be held constant for a period of 12 weeks.

Who is Eligible to Participate in the Study?

Men or women over the age of 18 with hard to treat epilepsy may be eligible to participate in this research study.

What is Involved With this Study?

Once enrolled in the study, the doctor or other staff will give participants a seizure diary and will explain how to use it. Every day, participants will enter information into the diary about the seizures experienced. Each month, participants will either talk to the doctor or other staff person on the telephone, or they will go to the office to visit and talk with the doctor.



At each appointment we will:

• review the seizure diary and talk about the seizures expereinced over the last month.


• ask questions from a standard questionnaire about the severity of the seizures.

There will be 5 office visits, with the initial visit lasting about one hour. Each subsequent visit is expected to last about 30 minutes. There will also be 8 telephone visits during the study (i.e., one phone call every 4 weeks) lasting about 15 minutes. Participation in this study will end after one year of collecting seizure information.

How long will the Study run?

Participation in the Prospective Seizure Frequency clinical investigation is expected to last for up to one year.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact Karla at (507) 538-9140.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 10/11/2005