Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - 70
Updated:8/10/2018
Start Date:September 2007
End Date:January 2009

Use our guide to learn which trials are right for you!

An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures

This study will evaluate the efficacy and safety of Brivaracetam to support the submission
file in the indication of adjunctive treatment in adolescents and adults with partial onset
seizures.


Inclusion Criteria:

- Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only
included where legally permitted and ethically accepted

- Subjects with well-characterized focal epilepsy or epileptic syndrome according to the
International League Against Epilepsy (ILAE) classification

- Subjects had a history of partial onset seizures (POS) whether or not secondarily
generalized (Type I seizures according to the ILAE classification)

- Subjects had at least 2 POS whether or not secondarily generalized per month during
the 3 months preceding Visit 1 (V1)

- Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week
Baseline Period

- Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic
drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a
concomitant AED

Exclusion Criteria:

- History or presence of seizures occurring only in clusters (too frequently or
indistinctly separated to be reliably counted) before Visit 3

- History or presence of status epilepticus during the year preceding Visit 1 or during
Baseline
We found this trial at
41
sites
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Burlington, MA
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chatswood,
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92660
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Springfield, IL
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tupelo, MS
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials