Refractory partial epilepsy, with or without secondary generalisation MedDRA version: 9.0 Level: LLT Classification code 10065336
Conditions
Interventions
Product Name: Oxcarbazepine modified release (MR)
Product Code: OXC MR
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OXCARBAZEPINE
CAS Number: 28721075
Current Sponsor code: OXC
Concent
Sponsors
Desitin Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male patients with minimal age of 18 years on the date of the first study visit. 2. Stable treatment with Oxcarbazepine (Trileptal® /Timox®), dosage: exactly 900 mg or exactly 1200 mg or exactly 1500 mg, for at least 1 month prior to screening. 3. = 2 partial onset seizures with or without secondary generalisation refractory to existing AED therapy within the baseline period. 4. Weight between = 50 kg and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Epilepsy secondary to progressive metabolic diease, malignant neoplasm, substance abuse, or active infection. 2. Status epilepticus at any time during the baseline period. 3. Lennox-Gastaut syndrome. 4. Generalized epilepsy as primary diagnosis. 5. Severe cardiac, pulmonary, haematological, hepatic, renal or neoplastic pathology. 6. Acute medical conditions and/or conditions that could interfere with the absorption, metabolism or excretion of oxcarbazepine. 7. History of clinically relevant psychiatric illness and/or drug abuse, drug addiction or alcoholism within the last 2 years. 8. Treatment with psychotropic drugs, anticholinergic drugs, anti-parkinson medication, alpha1-antagonists, alpha2-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. 9. 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. 10. Hypersensitivity towards oxcarbazepine or chemically related drugs or excipients of the study medication. 11. 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. 12. Pregnancy or breast feeding. 13. Participation in clinical trials during 3 months preceding the study. 14. Symptomatic hyponatremia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the maintenance dosage where dose uptitration has to be discontinued due to adverse events.;Secondary Objective: Secondary study objectives are to evaluate the adverse event profile, course of performance and cognition during up-titration to a maximum dose of 2700 mg/day with OXC MR in comparison with OXC IR by means of a validated Adverse Event Profile Plus Questionnaire and the EpiTrack test protocol and to compare both groups on the criteria Seizure frequency per 28 days and plasma concentrations of OXC and MHD obtained before morning dose and 1-3 hours after drug intake (immediately after Adverse Event Profile Plus and the EpiTrack test (n=6 patients/centre).;Primary end point(s): The maintenance dosage where dose up-titration has to be discontinued due to adverse events. | — |
Countries
Germany
Outcome results
None listed