Trials / Completed
CompletedNCT00615615
Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures
Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 4 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levetiracetam | * high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg * low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less |
| DRUG | Placebo | Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy |
Timeline
- Start date
- 1999-09-01
- Primary completion
- 2003-03-01
- Completion
- 2003-03-01
- First posted
- 2008-02-14
- Last updated
- 2020-07-30
Source: ClinicalTrials.gov record NCT00615615. Inclusion in this directory is not an endorsement.