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Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT01954121•UCB Pharma SA

View on ClinicalTrials.gov

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).

Eligibility

Age

16 - No limit years

Sex

ALL

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

Locations (28)

Beijing, China

Changchun, China

Chengdu, China

Chongqing, China

Guangzhou, China

Hangzhou, China

Key Dates

Start Date

September 1, 2013

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

August 15, 2017

Enrollment

436

ACTUAL participants

Conditions

EpilepsyPartial Seizures

Interventions

Levetiracetam

DRUG

Carbamazepine

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

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Epilepsy; Seizure

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RECRUITINGPHASE1

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NCT02531880

Epilepsy

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

MEHMO Natural History and Biomarkers