Overview

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

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UCB Pharma SA
Treatments:
Carbamazepine
Etiracetam
Levetiracetam
Piracetam
Criteria
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