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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy, Partial

Intervention: Levetiracetam (Drug); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: UCB Pharma

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Responder Rate for total partial onset seizures as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)

Secondary outcome:

Responder rate for total seizures (all types) as computed from the 48-hour Evaluation video-EEG (post-baseline) and the 48-hour Selection video-EEG (baseline)

Percent reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG

Percent reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG

Absolute reduction in Average Daily Frequency (ADF) of partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG

Absolute reduction in Average Daily Frequency (ADF) of total seizures (all types) recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG

Percent reduction in Average Daily Frequency (ADF) of electro-clinical partial onset seizures recorded on the 48-hour Evaluation video-EEG compared to those recorded on the 48-hour Selection video-EEG for children 1 month to less than 6 months old

Percentage of drop-outs for any reasons during the study

Percentage of drop-outs due to lack of efficacy during the study

Percentage of drop-outs before 24 hours of Evaluation video-EEG for reasons other than lack or loss of efficacy

Time to Exit (TTE) during the Evaluation Period

Eligibility

Minimum age: 1 Month. Maximum age: 4 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Buenos Aires, Argentina

Mendoza, Argentina

Pilar Buenos Aires, Argentina

Brussels, Belgium

Leuven, Belgium

Campinas, Brazil

Curitiba, Brazil

Porto Alegre, Brazil

Ribeirao Preto, Brazil

Rio de Janeiro, Brazil

Sao Paulo, Brazil

Brno, Czech Republic

Praha 4, Czech Republic

Praha 5, Czech Republic

Lille Cedex, France

Paris, France

Rouen Cedex, France

Strasbourg Cedex, France

Berlin, Germany

Erlangen, Germany

Heidelberg, Germany

Jena, Germany

Kiel, Germany

Budapest, Hungary

Calambrone, Italy

Genoa, Italy

Milano, Italy

Roma, Italy

Mexico City, Mexico

Gdansk, Poland

Bucharest, Romania

Cluj-Napoca, Romania

Tirgu-Mures, Romania

Kalingrad, Russian Federation

Moscow, Russian Federation

Saint Petersburg, Russian Federation

St Petersburg, Russian Federation

Glasgow, United Kingdom

London, United Kingdom

Birmingham, Alabama, United States

Mobile, Alabama, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

Vancouver, British Columbia, Canada

Los Angeles, California, United States

Gainesville, Florida, United States

Loxahatchee, Florida, United States

Miami, Florida, United States

Tallahassee, Florida, United States

Tampa, Florida, United States

Augusta, Georgia, United States

Boise, Idaho, United States

Chicago, Illinois, United States

Kehl, Kork, Germany

New Orleans, Louisiana, United States

Winnepeg, Manitoba, Canada

Boston, Massachusetts, United States

Detroit, Michigan, United States

St. Paul, Minnesota, United States

Lebanon, New Hampshire, United States

Cherry Hill, New Jersey, United States

Edison, New Jersey, United States

Buffalo, New York, United States

New York, New York, United States

Rochester, New York, United States

Syracuse, New York, United States

St John's, Newfoundland and Labrador, Canada

Chapel Hill, North Carolina, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

London, Ontario, Canada

Scarborough, Ontario, Canada

Portland, Oregon, United States

Danville, Pennsylvania, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Saskatoon, Saskatchewan, Canada

Spartanburg, South Carolina, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Salt Lake City, Utah, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Morgantown, West Virginia, United States

Milwaukee, Wisconsin, United States

Additional Information

Clinical Study Summary on UCB.com

Starting date: October 2004
Last updated: July 6, 2015

Page last updated: August 23, 2015

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