Trials / Completed
CompletedNCT00105040
A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures
A 19-week, Randomized, Double-blind, Multicenter, Placebo-controlled Safety Study to Evaluate the Cognitive and Neuropsychological Effects of Levetiracetam 20 - 60 mg/kg/Day, Divided in Twice Daily Dosing, as Adjunctive Treatment in Children 4 - 16 Years Old, Inclusive, With Refractory Partial Onset Seizures
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 4 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
A 12-week Evaluation Period will be used to characterize potential cognitive and neuropsychological effects of LEV (20 - 60 mg/kg/day), as adjunctive treatment in children 4 - 16 years old, inclusive, with refractory partial onset seizures when compared to adjunctive treatment with placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levetiracetam | Oral tablets or oral solution at 20-60 mg/kg/d, divided into twice daily dosing. |
| OTHER | Placebo (PB) | Oral tablets and oral solution |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2007-03-01
- Completion
- 2007-03-01
- First posted
- 2005-03-04
- Last updated
- 2015-03-02
Locations
45 sites across 3 countries: United States, Canada, South Africa
Source: ClinicalTrials.gov record NCT00105040. Inclusion in this directory is not an endorsement.