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

Completed · Phase 3 · Has a placebo group

Conditions studied: Epilepsy, Partial

In brief

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.

Key facts

Study ID

NCT00175890

Run by

UCB Pharma

People needed

116

Starts

2004-10-01

Expected to finish

2007-01-01

Last updated by the study team

2020-10-01

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Loxahatchee Groves, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Cherry Hill, New Jersey, United States
• Study site — Edison, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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