IRB Number:

08-002016

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

The primary purpose of this study is to evaluate a potential new treatment for epilepsy. Researchers want to find out if the investigational drug called perampanel is safe and can help people with partial seizures who are already taking seizure medications and the current seizure medications are not enough to control those seizures. Perampanel is being tested as a possible add-on drug for people with seizures who are taking other seizure medications.

Who is Eligible to Participate in the Study?

-- Are over 18 years of age, and
-- Have been diagnosed with refractory partial seizures, and
-- Have been treated with at least 2 different antiepileptic drugs in the past 2 years
-- Are currently on a stable dose of up to 3 antiepileptic drugs
-- Have at least 2 partial seizures in a 3-week period (not counting auras)

Minimum Age:

18

Maximum Age:

99

What is Involved With this Study?

The following tests and procedures will be conducted throughout the study (number of times performed):

• Informed Consent (1)


• Health Survey (2)


• Physical & Neurological Exam (4)


• Weight, Blood Pressure, Pulse, and Temperature (9)


• Height (1)


• Blood Test (7)


• Urine Drug Test (1)


• Urine Pregnancy Test (8, if applicable)


• Electrocardiogram/ECG (6)

The patient will be given a diary to keep track of his or her seizures every day during the first six weeks of the study. At the end of this period, the study doctor will decide whether the patient is eligible to participate in the study.

This study is double-blind, meaning that neither the study doctor nor the participant will know if they are taking active study drug or placebo (an inactive substance which looks like the real medicine but contains no active ingredient).
Eligible patients will be given the study drug or placebo to take once a day for about 19 weeks. They will continue to take their regular seizure medications in addition to the study medication or placebo. At the end of the study, patients may choose to participate in a follow-up study where all participants receive active study drug for 25 months.

How long will the Study run?

The study duration is 29 weeks and consists of 9 office visits. Additional visits may be scheduled if they are considered necessary. At the end of the study, participants have the option of taking part in a follow-up study for the next 25 months.

Who can I Contact for Additional Information on this Trial?

For more information, please contact Riann Boyd by phone: (904)953-7975 or E-mail: Boyd.riann@mayo.edu

What is/are the Locations of this Clinical Trial?

• Jacksonville, FL

Last updated: 07/08/2009