Trial Information

Summary: The purpose of this research program is to assess the effectiveness and safety of a study drug in patients with PGTC Seizures.

The drug being studied is an investigational form of a currently approved prescription medication for some types of epilepsy. This study drug is a new extended-release formulation which may allow patients with seizures to be on a once daily dosing regimen.

This clinical research study is for patients 13 years and older with a diagnosis of epilepsy with PGTC seizures for more than six months. Qualified participants must be currently treated with a stable regimen of 1-2 anti-epileptic drugs for at least four weeks prior to entering the study.

The study design will consist of a baseline period of 8 weeks to determine seizure frequency. At the end of this time, participants who qualify for enrollment may be randomly assigned to receive either varying doses of the study drug or matching placebo (non-active drug). This is a long term study that could last approximately a year and a half with up to 15 clinic visits. Participants may undergo evaluations including medical examination and laboratory tests for safety, and review of epilepsy seizure diary during clinic visits.

Study-related medications and study-related medical examinations are provided at no cost to participants. Reimbursement for time and travel may be provided.

A subject will be eligible for inclusion in this study if the following criteria apply:

• Is at least 13 years of age (male or female).
• Has a confident diagnosis of epilepsy with PGTC seizures.
• Is currently treated with a stable regimen of one or two AED(s) for at least four weeks.
• Is able and willing to maintain an accurate, complete, written daily seizure diary, or has a parent/caregiver who is able and willing to maintain an accurate, complete, written daily seizure diary for the entire duration of the study.

For more information visit www.clinicaltrials.gov

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Trial listings updated: June 1, 2008 at 5:44:47 AM