Remegal Different Doses in Patients With Refractory Partial Seizures

Phase II

Inclusion criteria

• Subject will report to have partial onset seizures for at least the last 2 years despite prior therapy with at least 2 different consecutive AEDs.
• Subject will report an average of at least 4 partial onset seizures per 28 days prior to entry in the Baseline phase.
• Seizure-free period will be no longer than 21 days in the 4-week period prior to entry in the Baseline phase.
• Subject will be on stable dosage regimen of a maximum of 3 AEDs,.
• The dosage of concomitant AED therapy will be kept constant for at least 4 weeks prior to entry into the Baseline phase.
• 'Subject will receive information will be given time to think about their participation and will give their written informed consent.
• Subject will be male or female between 18 and 65 years old.
• Subject will have a diagnosis of epilepsy with simple partial seizures and/or complex-partial seizures both with or without secondary generalization according to the ILAE (1981):

• The results of at least one prior electroencephalogram (EEG) and magnetic resonance imaging/computerized tomography scan should be consistent with the diagnosis of partial seizures.
• In the case of simple partial seizures, only those who motor signs will be included.

Exclusion criteria

• Subject with non-epileptic events including psychogenic seizures that could be confused with seizures.
• Subject with seizures that cannot be counted due to clustering.
• Subject with a history of primary generalized seizures.
• Subject with a history of status epilepticus within the 12 months period prior to trial entry.
• Subject with concomitant treatment of felbamate or previous felbamate therapy within the last 6 months prior to trial entry.
• Subject with concomitant treatment of vigabatrin. Subjects with previous vigabatrin therapy must have had a visual field test prior to trial entry.
• Subject with a progressive structural lesion in the central nervous system or a progressive encephalopathy.
• Subject who received REMEGAL in a previous trial.
• Subject currently participating or who participated within the last two months in any trial of an investigational drug or experimental device.
• Pregnant or nursing women and/or those of childbearing potential who are not surgically sterile, two years postmenopausal or do not practice two combined methods of contraception, unless sexually abstinent, during the duration of the trial.
• Subject with 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 trial.
• Subject with a history of chronic alcohol or drug abuse within the previous 2 years.
• Subject with alanine amino transferase (ALT), aspartate amino transferase (AST), alkaline phosphatase, total bilirubin, or serum creatinine level more than or equal to 2 times the upper limit of normal.
• Subject with clinically significant abnormal vital signs.
• Subject with a known history of severe anaphylactic reaction or serious blood dyscrasias.
• Subject with any other clinically significant disease, surgical condition or recent chronic consumption of non-AED medications (within the preceding four weeks prior to trial entry) that might reasonably have been expected to interfere with drug absorption, distribution, metabolism or excretion.
• Subject taking one of the following medications influencing the central nervous system within four weeks prior to trial entry: neuroleptics, monoamine oxidase (MAO) inhibitors, anxiolytics, amphetamines, sedative antihistamines, tranquilizers, hypnotics, narcotic analgesics, except for medication taken as epileptic treatment.
• Subject with confirmed clinically significant abnormality in ECG, including prolonged QTc interval.