Monotherapy in subjects with newly diagnosed epilepsy MedDRA version: 7.0 Level: LLT Classification code 10015037
Conditions
Sponsors
UCB S.A. Pharma Sector
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present trial is to assess the effectiveness of levetiracetam in monotherapy compared to the older AEDs (sodium valproate (VPA) or carbamazepine (CBZ)) evaluating the time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety. ;Secondary Objective: The secondary efficacy objectives are to measure the effectiveness or efficacy by using the following variables: - The time to withdrawal comparing LEV versus CBZ or LEV versus VPA - The retention rate after 6 and 12 months comparing LEV versus “old AED”, LEV versus CBZ or LEV versus VPA - Seizure freedom at 6 and 12 months comparing LEV versus “old AED”, LEV versus CBZ or LEV versus VPA - Time to first seizure comparing LEV versus “old AED”, LEV versus CBZ or LEV versus VPA - The safety and tolerability of LEV as monotherapy will be also evaluated. ;Primary end point(s): The analysis will be based on the ITT population unless stated otherwise. The primary efficacy variable is the time to withdrawal from study treatment and will be calculated from the date of randomization to the first date that the subject permanently discontinued the study treatment. The safety assessments will be made based on the following parameters: - Adverse events and serious adverse events reporting - Physical and neurological examinations - Vital signs, including body weight | — |
Countries
Austria, Czech Republic, Denmark, Finland, Germany, Hungary, Ireland, Italy, Portugal, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed