A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any - 4
Updated:4/21/2016
Start Date:October 2004
End Date:January 2007

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

A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age. N01009

To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in
pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects
will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an
evaluation). Other neuropsychological clinical assessments will be performed during the 34
day length of the study.


Inclusion Criteria:

- Pediatric patients from 1 month to less than 4 years of age

- Pediatric patients diagnosed with refractory partial onset seizures, on a stable
regimen of one to two other anti-epileptic drugs and at least 2 partial onset
seizures per week in the two weeks prior to screening

- Patients must have two partial onset seizures (with corresponding clinical event)
during the 48-hour video EEG at screening

Exclusion Criteria:

- A ketogenic diet

- Previous exposure to levetiracetam

- Seizures too close together to count accurately

- Treatable seizure etiology

- Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing
cerebral disease

- Diagnosis of a terminal illness
We found this trial at
43
sites
?
mi
from
Loxahatchee, FL
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
?
mi
from
Cherry Hill, NJ
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
Cleveland, 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
Danville, PA
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Edison, NJ
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
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
Miami, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
?
mi
from
Morgantown, WV
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 Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
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
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
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
?
mi
from
St. Paul, MN
Click here to add this to my saved trials
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Winston Salem, North Carolina 27157
?
mi
from
Winston Salem, NC
Click here to add this to my saved trials