Remegal Different Doses in Patients With Refractory Partial Seizures

Exclusion Criteria

• •1. Subject with non-epileptic events including psychogenic seizures that could be confused with seizures.
• •2. Subject with seizures that cannot be counted due to clustering.
• •3. Subject with a history of primary generalized seizures.
• •4. Subject with a history of status epilepticus within the 12 months period prior to trial entry.
• •5. Subject with concomitant treatment of felbamate or previous felbamate therapy within the last 6 months prior to trial entry.
• •6. Subject with concomitant treatment of vigabatrin. Subjects with previous vigabatrin therapy must have had a visual field test prior to trial entry.
• •7. Subject with a progressive structural lesion in the central nervous system or a progressive encephalopathy.
• •8. Subject who received REMEGAL in a previous trial.
• •9. Subject currently participating or who participated within the last two months in any trial of an investigational drug or experimental device.
• •10. 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.
• •11. 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.
• •12. Subject with a history of chronic alcohol or drug abuse within the previous 2 years.
• •13. 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.
• •14. Subject with clinically significant abnormal vital signs.
• •15. Subject with a known history of severe anaphylactic reaction or serious blood dyscrasias.
• •16. 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.
• •17. 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.
• •18. Subject with confirmed clinically significant abnormality in ECG, including prolonged QTc interval.