Trials / Completed
CompletedNCT00152516
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 255 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 1 Month – 16 Years
- Healthy volunteers
- Not accepted
Summary
To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | levetiracetam (LEV) | Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period. |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2005-09-09
- Last updated
- 2013-02-12
- Results posted
- 2010-01-13
Locations
84 sites across 16 countries: United States, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, India, Italy, Mexico, Poland, Romania, Russia, South Africa, United Kingdom
Source: ClinicalTrials.gov record NCT00152516. Inclusion in this directory is not an endorsement.