A MULTICENTER, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, POSITIVE CONTROLLED STUDY COMPARING THE EFFICACY AND SAFETY OF LACOSAMIDE (200 TO 600MG/DAY) TO CONTROLLED RELEASE CARBAMAZEPINE (400 TO 1200MG/DAY), USED AS MONOTHERAPY IN SUBJECTS (=16 YEARS) NEWLY OR RECENTLY DIAGNOSED WITH EPILEPSY AND EXPERIENCING PARTIAL ONSET OR GENERALIZED TONIC CLONIC SEIZURES

Conditions: Epilepsy, partial onset or generalised tonic-clonic seizures.
MedDRA version: 18.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders

Registration Number: EUCTR2010-019765-28-PL

Lead Sponsor: CB BIOSCIENCES GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Subjects must fulfill the following inclusion criteria to be eligible to participate in this study:
1. Subject has previously been assigned to treatment in this study or in a
study of the drugs under investigation in this study.
2. Subject is currently participating or has participated within the last 2
months in any study of an investigational drug or experimental device.
3. Subject has a history or presence of seizures of other types than
partial-onset (IA, IB, IC with clear focal origin) and generalized tonicclonic
(without clear focal origin) seizures (eg, myoclonic, absence).
4. Subject has a history or presence of seizures occurring in clustered
patterns, defined as repeated seizures occurring over a short period of
time (ie, <20 minutes) with or without function regained between 2 ictal
events.
5. Subject has experienced at least 2 unprovoked seizures (separated by a minimum of 48 hours) in the 12 months preceding randomization out of which at least 1 unprovoked seizure occurred in the 3 months preceding Visit 1.
6. Subject has had an electroencephalogram (EEG) and a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) exam of the brain within the past 12 months. If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they need to be completed and results must be available prior to randomization at Visit 2.

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

Exclusion Criteria

Subjects are not permitted to enroll in the study if any of the following criteria are met:
1.Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the drugs under investigation in this study 2.Subject is currently participating or has participated within the last 2 months in any other study of an investigational drug or experimental device 3.Subject has a history or presence of seizures of other types than partial-onset(IA,IB,IC with clear focal origin) and generalized tonic-clonic(without clear focal origin) seizures (eg,myoclonic,absence) 4.Subject has a history or presence of seizures occurring only in clustered patterns,defined as repeated seizures occurring over a short period of time (ie,<20 minutes) with or without function regained between 2 ictal events 5.Subject has a history,clinical,or EEG finding suggestive of idiopathic generalized epilepsy(IGE) at randomization(according to the ILAE Classification of Epileptic Seizures,1989) 6.Subject has current or previous diagnosis of pseudoseizures,conversion disorders,or other nonepileptic ictal events that could be confused with seizures based on expert opinion and/or EEG evidence.7.Subject has any medical or psychiatric condition,which in the opinion of the investigator,could jeopardize the subject’s health or would compromise the subject’s ability to participate in this study 8.Deleted and no longer applicable with Protocol Amendment 2(see protocol amendment details in Section 17.6) 9.Subject has a known hypersensitivity to any components of the investigational product(s) 10.Subject has ever been treated(for any indication) with LCM or CBZ in the past 11.Subject has been treated for epilepsy with any AED(including benzodiazepines) in the last 6 months before Visit 1
• However,acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 3 days prior to randomization
• Prior use of felbamate or vigabatrin is not allowed
• Benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week 12.Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1
13.Subject is taking benzodiazepines for a nonepilepsy indication 14.The use of monoamine oxidase inhibitors(MAOIs) is not allowed within 14 days of Visit 1 15.Subject has experienced seizure(s) while treated with any AED for an indication other than epilepsy 16.Subject is taking any drug or product(eg,grapefruit) that may influence CBZ metabolism(see Section 7.8.3) 17.Subject has a known history of severe anaphylactic reaction,serious blood dyscrasias,or hepatic porphyrias 18.Subject has an acute or sub-acutely progressive central nervous system disease 19.Subject has alanine aminotransferase (ALT),aspartate aminotransferase (AST), or total bilirubin levels=2× the upper limit of normal (ULN) or has alkaline phosphatase levels=3× the ULN
20.Subject has a medical condition that could reasonably be expected to interfere with drug absorption,distribution,metabolism, or excretion. 21.Subject has a history of alcohol or drug abuse within the previous 2 years 22.Subject is of Asian ancestry and tests positive for human leukocyte antigen HLA-B*1502 allele
23.Subject has impaired renal function, ie, creatinine clearance (CLcr) is lower than 30mL/min at Visit 1.Creatinine clearance will be estimated as follows