Status:
COMPLETED
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy, Partial
Eligibility:
All Genders
1-4 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00175890
Start Date
October 1 2004
End Date
January 1 2007
Last Update
October 1 2020
Active Locations (86)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States