NCT01954121

Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures

An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).

Conditions

• Epilepsy
• Partial Seizures

Interventions

Type	Name	Description
DRUG	Levetiracetam	Immediate release film-coated tablets at strengths of 250 mg and 500 mg. * Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid) * Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid * Down-titration Period (Week 30 up to Week 33)
DRUG	Carbamazepine	Immediate release tablets at a strength of 200 mg. * Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd) * Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid * Down-titration Period (Week 30 up to Week 33)

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-10-01
• Last updated: 2017-08-15
• Results posted: 2016-08-11

Locations

28 sites across 1 country: China