NCT01229735

Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: UCB Korea Co., Ltd. · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Levetiracetam	250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
DRUG	Topiramate	25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2010-10-28
• Last updated: 2017-08-15
• Results posted: 2016-02-12

Locations

24 sites across 1 country: South Korea