Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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.
Brief Summary: Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.


Options:
A: Inclusion Criteria:

* Diagnosis of epilepsy (all types of seizures) 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 are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method

Exclusion Criteria:

* Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
* 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
* Pregnant or lactating women
* Presence of known pseudoseizures within the last year
* Uncountable seizures (clusters) or history of convulsive status epilepticus
* Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
* History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
* 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
B: Inclusion Criteria:

* Age 60 yrs or above.
* New onset focal epilepsy i.e. either at least one epileptic seizure in the last 6 months and focal epileptiform discharges on EEG or a relevant lesion on CT/MRI or at least 2 epileptic seizures, one of which occurring in the last 6 months prior inclusion.
* No previous AED treatment, except for a period not longer than 4 weeks prior to inclusion (V0).
* Ability of subject to understand verbal and written instructions, to comply with all study requirements, and to comprehend character and individual consequences of the clinical trial.
* Written informed consent before enrolment in the trial.

Exclusion Criteria:

* Acute symptomatic epileptic seizures occurring acutely within a 2 week period after the onset of an acute illness such as cerebral haemorrhage, cerebral infarct, rapid progressive malignancy or other acute brain abnormalities (i.e. encephalitis, hypoxic brain damage, trauma, metabolic derangement, following brain surgery).
* Dementia (as defined by history)
* Renal insufficiency as defined by GFR \< 50 mL/min.
* Increased liver enzymes (GOT, GPT, gGT) or increased bilirubin ≥ 2-fold the upper limit of normal (ULN).
* Pre-treatment with valproic acid within the four weeks prior inclusion (V0).
* Contraindication against or history of hypersensitivity to any of the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products.
* Participation in other clinical trials and observation period of competing trials within the last 2 months, respectively.
* History of drug or alcohol abuse within the last 2 years.
* Medical condition which interferes with the participation in the trial according to the opinion of the investigator.
* Patients with life expectancy \< 1 year due to malignant disease
* Psychiatric morbidity requiring legal guardianship.
C: Inclusion Criteria:

* Seizures indicative of new-onset epilepsy (or epilepsy relapse) of untreated epilepsy
* at least one but not more than 20 unprovoked seizures within past 3 months
* weighing more than 110 pounds
* considered to be a good candidate for rapid initiation of anti-seizure medication
* able to swallow a tablet whole (without crushing it).

Exclusion Criteria:

* Not having taken anti-seizure medications within the past 30 days
* no provoking factors for seizures (presence of alcohol withdrawal, drug intoxication, acute meningitis or encephalitis, acute head injury or stroke, acute hypoxic/ischemic encephalopathy, or brain tumor)
* no presence of active liver disease or serious kidney disease
* not pregnant or breast-feeding
* not using birth control.
D: For inclusion in the study, subjects must fulfill all of the following at the time points indicated:

Visit 1 (Days -1 to -7; Screening)

* Have signed an informed consent before undergoing any study-related activities. Subjects of Asian ancestry (subjects with a direct ancestor of Asian origin, irrespective of the generational difference) are required to give written informed consent for genotyping.
* Male or female ≥18 years of age.
* Newly diagnosed epilepsy with at least 2 well documented, unprovoked, clinically evaluated and classified partial seizures (with or without secondary generalization) with clear focal origin, documented clinically OR by electroencephalogram (EEG) OR by imaging studies, within 12 months of Visit 1. In this context, seizures that occur within a period of 48 hours are counted as one seizure.
* At least 1 seizure during the previous 3 months.
* Demonstrated cooperation and willingness to complete all aspects of the study.
* Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum ß-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study visit (PSV).

Visit A1 (Day 1; Randomization and start of double-blind treatment period)

* Have satisfactorily completed the electronic subject diary (eDiary).
* Female subjects with childbearing potential must not be pregnant as confirmed by a negative urine pregnancy test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the PSV.

Subjects having any of the following at the time points indicated are to be excluded from the study:

Visit 1 (Days -1 to -7)

* History of pseudo-seizures
* Seizures occurring only in clusters.
* History of absence, myoclonic, clonic, tonic, or atonic seizures.
* Documented EEG within 12 months of Visit 1 suggestive of primarily generalized epilepsy.
* History of status epilepticus within the 3 months prior to Visit 1.
* Known progressive neurologic disorder (progressive brain disease, epilepsy secondary to progressive cerebral lesion) as assessed by magnetic resonance imaging or computer tomography.
* Former or current use of any anti-epileptic drug (AED), except for the use of a single AED for a maximum duration of 2 weeks before Visit 1.
* Previous use of ESL or carbamazepine (CBZ).
* Using mono-amine oxidase inhibitors (MAOIs), tricyclic antidepressants, nefazodone, isoniazid, or protease inhibitors or any other anti-retroviral agents (e.g. efavirez) that may raise the levels of CBZ-CR.
* Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants.
* History of uncontrolled psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months, a history of suicide attempt, schizophrenia, chronic treatment with benzodiazepines (except short-acting benzodiazepines) or barbiturates.
* Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide-Severity Rating Scale (C-SSRS).
* History of alcohol, drug, or medication abuse within the last 2 years.
* Uncontrolled cardiac (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, hematological, or oncology disorder.
* History of bone marrow depression.
* History of hepatic porphyrias (e.g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda).
* Relevant clinical laboratory abnormalities (e.g. sodium \<130 mmol/L, alanine or aspartate transaminases \>2 x the upper limit of normal, white blood cell count \<3000 cells/mm3) (measured at Visit 1).
* Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (measured at Visit 1).
* Subjects of Asian ancestry who test positive for the presence of the HLA-B\*1502 allele.
* Pregnancy or lactating.
* Participation in other drug clinical trial within the last 2 months or having received an investigational medicinal product (IMP) within 5 half-lives of that IMP, whichever is longer.
* Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.

Visit A1 (Day 1)

* Former or current use of any AED, except for the use of a single AED for a maximum duration of 2 weeks before Visit 1 and with a drug-free period of at least 5 days before Visit A1. Benzodiazepines are allowed, no more than twice a week, for an epileptic indication and as rescue medication during the ≥5-day drug-free period.
* Using prohibited medication.
* Pregnancy.
* Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.

Answer: A