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

UCB

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Partial Seizures

Treatments

Drug: Levetiracetam

Drug: Carbamazepine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01954121

N01364

Details and patient eligibility

About

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).

Enrollment

436 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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