NCT01506882

An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy

An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.

Conditions

• Epilepsy
• Partial Onset Seizures

Interventions

Type	Name	Description
DRUG	Levetiracetam (LEV)	* Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: LEV 250 mg, LEV 500 mg * Frequency: Twice daily * Route of Administration: Oral use

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-10-01
• Completion: 2015-04-01
• First posted: 2012-01-10
• Last updated: 2015-12-31
• Results posted: 2014-10-13

Locations

27 sites across 1 country: Japan