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OpenTrials
Completed

NCT Number: NCT01954121

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

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).

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Partial Seizures Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

13, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Immediate 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)

Other names: Keppra

carbamazepine

Drug

Immediate 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)

Other names: Tegretol

Primary outcomes

  1. Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period

    Time frame: 6-months Evaluation Period (From Week 4 to Week 30)

Secondary outcomes

  1. Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period

    Time frame: From Week 1 to Week 30

  2. Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period

    Time frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)

    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.

  3. Time to First Seizure During the Evaluation Period

    Time frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)

    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.

  4. Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug

    Time frame: From Randomization (Week 1) up to Evaluation Visit (Week 30)

    Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.

Sponsors and collaborators

Lead sponsor

UCB Pharma SA

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2013
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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