| Ad Title: |
Brivaracetam-evaluation of efficacy and safety |
| Study Title: |
An International, Double-Blind, Parallel-Group, Placebo-Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>/= 16-70 years old) With Partial Onset Seizures. |
| Protocol Number: |
082007-042 |
| Department(s) involved in the Study: |
Neurology
|
| Purpose of the Study: |
An international, double-blind, parallel group, placebo-controlled, randomized study of brivaracetam |
| Participant Eligibility: |
* Subjects from 18 to 70 years old.
* Body weight over 99 pounds.
* Female subjects without childbearing potential.
* Subject capable of understanding and completing daily diaries, visit schedules and medication intake.
* Well characterized focal epilepsy ot epileptic syndrome.
* Must have EEG compatible with diagnosis of focal epilepsy within 5 years.
* Must have Brain MRI or CT scan peformed within the last 2 years.
* History of partial onset seizures whether or not secondarily generalized.
* Must have at least 2 partial onset seizures per month during the 3 months preceding first visit.
* Must have at least 8 partial onset seizures during the 8 week baseline period.
* Must be uncontrolled while treated by 1 to 2 permitted antiepileptic drugs.
* If VNS, must be implanted for at least 9 months and must be on a stable dose of anti-seizure medication(s) for at least 1 month prior to first visit and remain on stable dose(s) of medications during the treatment period. |
| Disease/Condition Under Study: |
Partial Onset seizures, whether or not secondarily generalized |
| Cancer Related Study: |
No
|
| Study Drug(s): |
brivaracetam
|
| Study Device(s): |
|
| Study Doctor: |
Dr. Paul Van Ness |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Parkland Memorial Hospital
|
Yes
|
|
Aston Ambulatory Care Center
|
Yes
|
|
| Contact Phone: |
214_648_6721 |
| Email: |
paul.van_ness@utsouthwestern.edu |
| Other Information: |
* Cannot have diagnosis of Status Epilepiticus 1 year prior to first visit.
* Cannot have any history of cardiovascular or peripheral vascular
disease.
* Cannot have terminal illness or presence of a serious infection.
* Cannot have a history of Liver disease or Kidney disease.
* Cannot have a history of "cluster" seizures. |
| Website Keywords: |
Neurology
|
| Medical Keywords: |
Epilepsy
|
