Study investigating lacosamide- already approved by the European Medicines Agency as add on therapy for the treatment of partial-onset seizures in a new indication- in patients with new or recently diagnosed with epilepsy and experiencing partial-onset or generalized tonic-clonic seizures. Study has two groups: One group of patients will be treated with lacosamide + placebo and a second one with carbamazepine + placebo. Neither the patient nor the doctor will know the treatment group.

Conditions: Epilepsy, partial onset or generalised tonic-clonic seizures.
MedDRA version: 18.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2010-019765-28-DE

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. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Consent form or a specific Assent form, where required, will be signed and dated by minors.
2. Subject is willing and able to comply with all study requirements.
3. Subject is male or female and =16 years of age. Minors will be included in some countries only if legally permitted.
4. Subject has newly or recently diagnosed epilepsy having experienced unprovoked POS (IA, IB, IC with clear focal origin) or generalized tonic-clonic seizures (without clear focal origin) that are classifiable according to the ILAE Classification of Epileptic Seizures, 1981. The discrimination between IC and IIE is not requested for inclusion.
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: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 850
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

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 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 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 a history, clinical, or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization (according to the ILAE Classification of Epilepsies and Epileptic Syndromes, 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:
Adult males: CLcr=(140-age)×weight in kg/(72×