A randomized, phase III, double blind, active-controlled, two-armed, multi-center study on efficacy and safety of once-daily oxcarbazepine (-modified release formulation) versus twice-daily oxcarbazepine (Timox®) in 300 patients with partial onset epilepsy - OXC retard
- Conditions
- Partial onset epilepsy
- Registration Number
- EUCTR2004-002260-25-AT
- Lead Sponsor
- Desitin Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method