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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to investigate the safety and efficacy of a novel formulation of oxcarbazepine that is released more slowly than the current formulation. The study medication will be used as a treatment against partial epilepsy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Desitin Arzneimittel GmbH
• Collaborator: FGK Clinical Research GmbH
• Treatments: Carbamazepine; Oxcarbazepine

Criteria

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.