Trial Information

Summary: A Study to Evaluate the Effects of Two Marketed Drugs in Patients with Epilepsy.

The purpose of this research study is to evaluate the effects of two FDA-approved drugs in participants with partial seizures. This is a clinical research study, lasting 20 weeks, for participants 16 years and older who have experienced at least two partial or complex partial seizures in the previous six months. Qualified participants will be randomly assigned to receive one of two study medications. Participants will continue with their current therapy, in addition to the study drug, for the duration of this study.

A total number of six clinic visits will be scheduled during which participants may undergo evaluations including study-related physical examination, vital sign monitoring, and laboratory tests. Participants will be required to maintain a daily diary card to record number of seizures, other medications, and adverse events (if any).

Inclusion Criteria:

• Age 16 or older
• Has a confident diagnosis of epilepsy.
• Has experienced at least 2 simple partial or complex partial seizures with or without secondary generalization in the previous 6 months.
• Is currently treated with a stable dose (i.e., at least 4 weeks) of either carbamazepine or phenytoin as monotherapy.

Exclusion Criteria:

• Has been non-responsive to a previous trial with lamotrigine or levetiracetam at therapeutic doses, or has a history of hypersensitivity to either drug.
• Has received an investigational drug within 30 days prior to enrollment, or plans to take an investigational drug anytime during the study.
• Currently receiving antidepressant or antipsychotic medication.

And other inclusion or exclusion criteria to be evaluated by the clinical research physician.

Healthy Volunteers: no
Gender: Both
Minimum Age: 16 Years
Maximum Age: N/A

Click Here to find out if you might qualify for this study, or visit www.findclinicals tudy.com.

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Trial listings updated: June 1, 2008 at 5:43:38 AM