CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 436 enrolled
Drug / intervention
Levetiracetam +1 moredrug
Likely dose
Levetiracetam 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01954121
NCT01954121Phase 3Completed
CompareCT.gov

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

UCB Pharma SA·interventional·Posted Oct 1, 2013·Updated Aug 15, 2017

In Brief

A Phase 3 clinical trial evaluating Levetiracetam and Carbamazepine for Epilepsy and Partial Seizures. Completed, enrolled 436 participants across 28 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial Seizures
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 1, 2013
Enrollment StartSep 1, 2013
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.8 years ago

Interventions

Levetiracetamdrug

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)

Carbamazepinedrug

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)