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

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).

Study Overview

• Status: Completed
• Conditions: Epilepsy; Partial Seizures
• Intervention / Treatment: Drug: Levetiracetam; Drug: Carbamazepine

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • 13
  • Changchun City, China
    • 16
  • Chengdu, China
    • 10
  • Chengdu, China
    • 5
  • Chongqing, China
    • 4
  • Guangzhou, China
    • 11
  • Guangzhou, China
    • 1
  • Guangzhou, China
    • 20
  • Guangzhou City, China
    • 26
  • Hangzhou, China
    • 24
  • Harbin, China
    • 22
  • Kunming, China
    • 29
  • Nanjing, China
    • 21
  • Nanjing City, China
    • 23
  • Nanjing City, China
    • 6
  • Nanjing City, China
    • 8
  • Qingdao, China
    • 27
  • Shanghai, China
    • 14
  • Shanghai, China
    • 15
  • Shanghai, China
    • 18
  • Shanghai, China
    • 2
  • Shijiazhuang, China
    • 19
  • Suzhou, China
    • 3
  • Taiyuan, China
    • 9
  • Tianjin, China
    • 25
  • Wuhan, China
    • 12
  • Xi'an, China
    • 7
  • Xian, China
    • 17

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levetiracetam; Levetiracetam 1000 mg/day	Drug: Levetiracetam; 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
Active Comparator: Carbamazepine; Carbamazepine 400 mg/day	Drug: Carbamazepine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period	6-months Evaluation Period (From Week 4 to Week 30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period		From Week 1 to Week 30
Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period	Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.	From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Time to First Seizure During the Evaluation Period	Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.	From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug	Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.	From Randomization (Week 1) up to Evaluation Visit (Week 30)

Collaborators and Investigators

• Sponsor: UCB Pharma SA

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimate): October 1, 2013

Study Record Updates

• Last Update Posted (Actual): August 15, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Epilepsy; China; Monotherapy; Levetiracetam; Keppra; Partial-onset Seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Nootropic Agents; Levetiracetam; Carbamazepine
• Other Study ID Numbers: N01364