EXTENT: EXtended Tolerability and Efficacy of a Novel Formulation of Oxcarbazepine in a Trial in Partial Epilepsy

This is an interventional treatment trial for Partial Epilepsy focused on measuring Epilepsy, oxcarbazepine Read More

Inclusion Criteria:

• Female and male patients with minimal age of 18 years on the date of the first study visit.
• Stable treatment with Oxcarbazepine treatment (Timox® /Trileptal®), dosage: exactly 900 mg or exactly 1200 mg or exactly 1500 mg for at least 1 month prior to screening.
• >= 2 partial onset seizures with or without secondary generalisation refractory to existing AED therapy within the baseline period.
• Weight between >= 50 kg and < 100 kg.
• for females with child-bearing potential: negative pregnancy rest and highly effective form of birth control (females using hormonal contraceptives should use a different or additional means of birth control, e.g. IUD, abstinence, vasectomized partner, double barriere methods with or without oral contraceptives)
• Stable regimen of <= 2 concomitant AEDs (vagus nerve stimulator included) during the baseline period; lamotrigine dose may be adjusted at baseline.
• Ethnic origin: Caucasian.
• Subjects capable of complying with the study stipulations.
• Patients who have provided written informed consent to participate in this study.

Exclusion Criteria:

• Epilepsy secondary to progressive metabolic disease, malignant neoplasm, substance abuse, or active infection.
• Status epilepticus at any time during the baseline period.
• Lennox-Gastaut syndrome.
• Generalized epilepsy as primary diagnosis.
• Severe cardiac, pulmonary, haematological, hepatic, renal or neoplastic pathology.
• Acute medical conditions and/or conditions that could interfere with the absorption, metabolism or excretion of oxcarbazepine.
• History of clinically relevant psychiatric illness and/or drug abuse, drug addiction or alcoholism within the last 2 years.
• Treatment with psychotropic drugs, anticholinergic drugs, anti-parkinson medication, α1-antagonists, α2-antagonists, carbamazepine, topiramate, felbamate, vigabatrin. Stable treatment with selective serotonin-reuptake-inhibitor (SSRI) having been given for at least 4 weeks prior to screening as supportive treatment of partial epilepsy can be accepted.
• Intake of sodium lowering medication, e.g. diuretics and non-steroidal anti- inflammatory drugs. Occasional and short-term intake of non-steroidal anti- inflammatory drugs on demand (Ibuprofen, Paracetamol, ASS, Diclofenac and others) is allowed.
• Hypersensitivity towards oxcarbazepine or chemically related drugs.
• Low sodium serum levels (< 128 mmol/L). Sodium serum levels ≥ 126 and < 128 mmol/L can be accepted for inclusion, if these levels have been stable for at least 3 months.
• Symptomatic hyponatremia.
• Pregnancy or breast feeding.
• Participation in drug trials during 3 months preceding the study.