Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects With Seizures Indicative of New Onset Epilepsy
Brief Summary: The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug to an effective dose, may include severe or frequent seizures, or high risk to the patient of recurrent seizures.


Options:
A: Inclusion criteria:

* Male or Female ≥13 years of age
* Have a confident diagnosis of epilepsy with partial seizures for at least 24 weeks prior to the Baseline Phase
* Have a documented history of partial seizures such that the investigator must judge that the subject is likely to have at least 4 partial seizures during the 8-week Baseline Phase.
* Have experienced at least 4 partial seizures (i.e., simple or complex partial seizures with or without secondary generalization) during an 8-week (i.e., 56 days) prospective Baseline Phase with at least one partial seizure occurring during each 4-week (i.e., 28-day) period.
* NOTE: With prior authorization from GlaxoSmithKline (GSK), retrospective data may take the place of up to the first 4 weeks (i.e., first 28 days) of the Baseline Phase for subjects providing reliable documentation of the following:

  1. A complete daily seizure diary that includes the number, and type (i.e., simple or complex partial seizures with or without secondary generalization), of seizures experienced each day for up to 28 consecutive days immediately prior to the prospective Baseline Phase
  2. Stability of prescribed dosages of background antiepileptic drug (AED)
  3. Compliance with background AED

All subjects permitted to use retrospective baseline data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The retrospective plus the prospective Baseline Phases must equal the 56 consecutive days prior to the start of dosing with study drug.

* be currently receiving AED monotherapy treatment with a stable regimen of a non-enzyme inducing AED for at least four weeks prior to starting the Baseline Phase.
* be able and willing to maintain an accurate, complete, written daily seizure diary, or has a parent/caregiver who is able and willing to maintain and accurate, complete, written daily seizure diary for the entire duration of the study.
* be able to comply with the dosing of study drugs, background AED, and all study procedures.
* understand and sign written informed consent, or will have a parent or a legally authorized representative who has done so, prior to the performance of any study assessments
* if female, and of childbearing potential be using an acceptable form of birth control, to include one of the following:

  1. Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (a minimum of 2 weeks).
  2. Consistent and correct use of one of the following methods of birth control:

Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject.

Any intrauterine device (IUD) with a documented failure rate of less than 1% per year

Double barrier method consisting of spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm).

NOTE: Women who have had a hysterectomy, tubal ligation, or are post-menopausal are considered to be of non-childbearing potential.

NOTE: A pharmacokinetic interaction has been observed between lamotrigine (LTG) and estrogen-based oral contraceptives. Therefore, the use of hormonal therapy (e.g., for contraception or hormone replacement therapy) is not allowed.

Exclusion criteria:

* Exhibits any primary generalized seizures (e.g., absence, myoclonic primary generalized tonic-clonic seizures).
* Has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
* Is taking an enzyme-inducing AED (EIAED - e.g. carbamazepine, phenytoin, phenobarbital, primidone) or is taking more than 1 background AED.
* Is currently taking lamotrigine (LTG) or has previously had an adequate trial of LTG.
* Is currently taking felbamate
* Is using hormone therapy
* Is abusing alcohol and/or other substances
* Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study.
* Is receiving chronic treatment with any medication that could influence seizure control
* NOTE: Use of benzodiazepines is allowed as specified in Section 8.1.2
* Is currently following the ketogenic diet.
* Is using vagal nerve stimulation
* Is planning surgery to control seizures during the study.
* Is pregnant, breastfeeding, or planning to become pregnant during the study or within the three weeks after the last dose of study drug.
* Is suffering from acute or progressive neurological disease, severe psychiatric disease or severe mental abnormality that is likely to interfere with the objectives of the study.
* Has any clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs.
B: 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.
C: Inclusion Criteria:

* Age ≥ 12 years
* Body weight ≥ 30kg (patients 12-15 years of age) and ≥ 40kg (patients over 16 years of age), respectively
* Either one epileptic seizure with high risk of relapse (partial seizure semiology, MRI lesion or pathological focal EEG findings) or a newly diagnosed epilepsy (≥ 2 unprovoked seizures) with at least 1 seizure within the past 3 months before begin of trial participance
* Treatment with no or a maximum of one anticonvulsant drug at the time of inclusion
* Fertile women of ≥ 16 years of age must use at least one of the following contraceptives for at least one month prior to initiation of trial participance: Oral contraceptive, contraceptive diaphragm, intrauterine contraceptive device (coil), tube ligation. For girls between 12 and 15 years of age a written confirmation of sexual abstinence, given by a person having the care and custody of the child, is sufficient.
* Informed consent by the proband in written form after being informed about character, relevance and consequences of the clinical trial, and additional informed consent given by a person having the care and custody of the child for patients between 12 and 17 years of age, respectively.

Exclusion Criteria:

* Patients with non-epileptic seizures or acute symptomatic seizures whose cause can be corrected
* Patients who suffer from absence seizures or simple partial seizures without motor signs (aura) only
* Patients who had a chronic focal epilepsy or an epileptic state in their medical history
* Patients with progressive neurological, degenerative or malignant diseases which are clinically relevant from the investigator's point of view (e.g. cardiovascular or endocrinic diseases)
* Patients who have been treated with Levetiracetam or Lamotrigine before
* Patients with known manifest renal insufficiency (creatinine clearance \< 80 mL/min)
* Patients with known hypersensitivity to Levetiracetam, Lamotrigine or another component of the trial drugs
* Patients who are attended by a legal guardian
* Patients suffering from a psychiatric disease or affective disorders (within the past 6 months), which had to be treated with electric convulsive therapy, tranquilizing agents, monoamine oxidase inhibitors or CNS-active sympathomimetics (e.g. methylphenidate)
* Patients who were suffering from alcohol- or drug-addiction within the past 12 months
* Pregnant or breast-feeding women
* Patients who participated in another clinical trial within the past 30 days
D: 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

Answer: B