Open-label, randomized, active-controlled study of Levetiracetam (LEV) used as monotherapy in patients with Partial-Onset Seizures

• Conditions: EpilepsyPartial Seizures; MedDRA version: 18.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 18.1Level: PTClassification code 10061334Term: Partial seizuresSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004586-84-Outside-EU/EEA
• Lead Sponsor: CB Pharma SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-12
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 436

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 36
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to demonstrate the noninferiority of the efficacy of Levetiracetam (LEV, 1000 mg/day) versus Carbamazepine immediate-release (CBZ-IR, 400 mg/day) used as monotherapy for at least 6 months. Efficacy will be measured as a primary variable by 6-month seizure freedom in adult subjects (=16 years of age) who are newly or recently diagnosed with epilepsy and are experiencing partial onset seizures (POS) with or without secondarily generalized seizures.;Secondary Objective: The secondary objective is to compare the safety and tolerability of both drugs in the same population.;Primary end point(s): Proportion of subjects remaining seizure free during the 6-months Evaluation Period;Timepoint(s) of evaluation of this end point: 6-months Evaluation Period (From Week 4 to Week 30)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Proportion of subjects retained in the study for the duration of the 30-week period covering the Up Titration Period, Stabilization Period, and Evaluation Period <br>- Time to first seizure or discontinuation due to an Adverse Event (AE) / Lack of Efficacy (LOE) during the Evaluation Period (from the first day in the Evaluation Period following stabilization)<br>- Time to first seizure during the Evaluation Period (from the first day in the Evaluation Period following stabilization)<br>- Time to first seizure during the period covering the Up Titration Period, Stabilization Period, and Evaluation Period from the first dose of study drug<br>;Timepoint(s) of evaluation of this end point: - From Week 1 to Week 30<br>- From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)<br>- From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)<br>- From Randomization (Week 1) up to Evaluation Visit (Week 30)