ClinicalTrials.Veeva

Menu

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

UCB logo

UCB

Status and phase

Completed
Phase 3

Conditions

Epilepsy
Partial Seizures

Treatments

Drug: Levetiracetam
Drug: Carbamazepine

Study type

Interventional

Funder types

Industry

Identifiers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

436 participants in 2 patient groups

Levetiracetam
Experimental group
Description:
Levetiracetam 1000 mg/day
Treatment:
Drug: Levetiracetam
Carbamazepine
Active Comparator group
Description:
Carbamazepine 400 mg/day
Treatment:
Drug: Carbamazepine

Trial contacts and locations

28

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems