A therapeutic confirmatory, open-label, multi-center, randomized 2 parallel groups, community-based trial studying the efficacy and safety of levetiracetam (1000 to 3000 mg/day oral tablets 250-500 mg b.i.d.) compared to sodium valproate (1000 to 2000 mg/day oral ER tablets 300-500 mg b.i.d.) and carbamazepine (600 to 1600 mg/day oral CR tablets 200-400 mg b.i.d.) as monotherapy in subjects with newly diagnosed epilepsy. - KOMET

Conditions: Monotherapy in subjects with newly diagnosed epilepsy
MedDRA version: 7.0Level: LLTClassification code 10015037

Registration Number: EUCTR2004-001339-41-FI

Lead Sponsor: CB S.A. Pharma Sector

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

•Written informed consent signed and dated by the subject or legally acceptable representative(s).
•Male /female adolescent & adult subjects (age = 16 years old where inclusion in a clinical trial is permitted by law, otherwise = 18 years old).
•Diagnosis of epilepsy (all types of seizures may be included) was made during the past year.
•Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months.
•Female subjects without childbearing potential (2 years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral contraceptives with a least 50 ?g ethinylestradiol per intake, intrauterine device, diaphragm plus spermicide, male condom plus spermicide, female condom, monogamous relationship with a vasectomized partner are acceptable methods. Abstinence will be considered as an acceptable method of contraception on a case-by-case basis upon discussion with UCB CRP or its representative. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status.
•Be considered as reliable and capable of adhering to the protocol, according to the judgement of the Investigator, e.g. able to understand and complete diaries and questionnaires.

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 previously allocated to a trial treatment used in this trial (CBZ, VPA or LEV).
•Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial.
•History of questionable compliance to visit schedule or medication intake; subjects not expected to complete the trial.
•Pregnant or lactating women
•Sexually active women with childbearing potential who are not using a medically accepted birth control method.
•Previous AED treatment, i.e.:
- Subjects ever treated (any indication) with LEV or CBZ or VPA in the past.
- Subjects treated for epilepsy with any AED in the last 6 months before V1. However, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration, and if treatment was stopped at least 1 week before V1. For phenobarbital and phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1.
•Presence of known pseudoseizures within the last year.
•Uncountable seizures (clusters) or history of convulsive status epilepticus.
•Presence or history of allergy to the components of Levetiracetam tablets (lactose, cornstarch, and excipients) or other pyrrolidine derivatives. Subjects with a history of multiple drug allergies or ingredients can be enrolled at the Investigator’s discretion.
•Hematological parameters: absolute neutrophil counts < 1,800/mm3 and/or platelet counts < 100,000/mm3.
•Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs (e.g., end stage renal disease, subjects on dialysis, subjects with hepatic impairment, etc.) Subjects with mild to moderate renal impairment may participate in the trial (creatinine clearance > 30mL/min).
•History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years. (Subjects who have been using anxiolytics for treatment of anxiety symptoms or anti-depressants at a stable dose at least six months prior to the trial may participate in the trial. The anxiolytic or anti-depressant must remain at the same stable dose throughout trial participation.)
•Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
•Presence of a terminal illness or any medical condition that might interfere with the subject’s trial participation.
•Scheduled elective surgery.