Epilepsy | Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
Epilepsy research study
What is the primary objective of this study?
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).
Who is eligible to participate?
Inclusion Criteria: - Subject is of Chinese origin and ≥ 16 years of age - Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS) - Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization - Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS Exclusion Criteria: - Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele - Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS) - Subject has only experienced type IA nonmotor seizures - Subject has a history or presence of seizures occurring only in clustered patterns - Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization - Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures - Subject has a history of Status Epilepticus
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LevetiracetamImmediate 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:CarbamazepineImmediate 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)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
LevetiracetamLevetiracetam 1000 mg/day
CarbamazepineCarbamazepine 400 mg/day
Start Date: September 2013
Completed Date: September 2015
Phase: Phase 3
Primary Outcome: Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
Secondary Outcome: Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period
Study sponsors, principal investigator, and references
Principal Investigator: UCB Clinical Trial Call Center
Lead Sponsor: UCB Pharma SA