Trial Information

Summary: Epilepsy and non-controlled partial seizures

We are conducting a clinical research study for volunteers diagnosed with Epilepsy with partial-onset seizures with or without secondarily generalization. This study tests the effectiveness of an investigational drug reducing seizure frequency in subjects not fully controlled despite optimal treatment with 1 to 2 antiepileptic medications (AED’s), compared to placebo.

Study Criteria:

• Age 16-70
• Body weight = 99lbs
• Focal epilepsy supported by and EEG and CT/MRI
• Must experience at least 8 partial seizures during an 8-week baseline period
• Current treatment with a maximum of 2 AED(s). Vagal nerve Stimulation (VNS) is allowed and not counted as an AED
• If using a VNS, it must have been implanted for at least 9 months
• Subjects cannot be taking felbamate or vigabatrin
• No history of cerebrovasular accident (CVA), including transient ischemic attack (TIA) in the last 6 months
• No severe cardiovascular disease or peripheral vascular disease
• No presence of a terminal illness or serious infection
• No history of a suicide attempt
• No ongoing psychiatric disease other than mild controlled disorder
• Cannot have known multiple drug allergies or severe drug allergy
• No history of drug and/or alcohol abuse in the last 2 years
• Cannot need the use of benzodiazephines frequently (more than once a week)
• Subjects cannot have been previously treated with bivaracetam

If eligible, you will receive investigational drug and study-related medical care at no cost. Reimbursement for time and travel may also be available.

For additional information about this study or to enroll, visit our website:
www.clinicaltrialsinc.com

If you would like to learn more about participating in this study, please send an e-mail message using the form below.