Partial onset epilepsy
Conditions
Interventions
Trade Name: Timox
Product Name: Timox
Pharmaceutical Form: Tablet
Product Name: Oxcarbazepine retard
Product Code: Oxcarbazepine sustained release formulation
Pharmaceutical Form: Tablet
Pharmaceutic
Sponsors
Desitin Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with partial onset epilepsy with or without secondar generalization with either monotherapy with carbamazepine or oxcarbazepine or therapy with carbamazepine or oxcarbazepine and one additional antiepileptic drug Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. epilepsy secondary to progressive methabolic disease, malignant neoplasm, substance abuse, or active infection; epilepsy due to an intracranial process without any progression may be tolerated. 2. primary generalized epilepsy 3. severe cardiac, pulmonary, hematological, hepatic, renal, gastrointestinal or neoplastic disease; 4. acute medical conditions and/or conditions that could interfere with the study aims 5.relevant hepatopathy (ALT or AST > 100 U/l, gGT > 150 U/l, bilirubin > 1,5 mg/dl) 6. Relevant nephropathy (creatinine > 1.4 mg/dl) 7. low sodium levels (<130 mmol/l) 8 history of atrioventricular block and/or clinically relevant arrhythmia 9.intake of bezodiazepines on more than occasional basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm non-inferiority of the once-daily application of the sustained release study preparation (SR-OXC) compared to the twice-daily immediate release reference preparation Timox®(IM-OXC).;Secondary Objective: Proportion of patients remaining seizure-free during the 12 weeks of randomised treatment; proportion of adverse events;Primary end point(s): The primary endpoint for statistical analysis is the time-to exit (failure time), i.e. the time when one of the exit creiteria is fulfilled. It is of no clinical relevance for which reason the patient stopped continuing the treatment. | — |
Countries
Austria
Outcome results
None listed