NCT01392768

Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization

A Double-blind, Phase III, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam as Adjunctive Therapy, in Partial Seizures Control Associated With Refractory Focal Epilepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether levetiracetam as adjunctive therapy is effective in the treatment of partial seizures, with or without secondary generalization, associated with refractory focal epilepsy.

Conditions

• Epilepsy
• Partial Seizures

Interventions

Type	Name	Description
DRUG	Levetiracetam	Oral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam)
DRUG	Placebo	Placebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2011-07-13
• Last updated: 2016-10-31