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Therapeutic Areas: Neurology
Disease Category: Epilepsy
Trial Information
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
Lauren Landers
Clinical Trials, Inc
Two Lile Court, Suite 100
Little Rock, AR 72205
Phone: 501-227-6179
Fax: 501-221-3426
EMail: Llanders@clinicaltrialsinc.com
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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