Safety and Efficacy of Novel Modified Release Formulation of Oxacarbazepine (OXC MR) vs an Immediate Release Oxacarbazepine (OXC IR) Product in Patients with Partial Epilepsy. Open-Labelled, Controlled, Parallel Group, Flexible Dose, Multicentre Study

Phase 1

• Conditions: Refractory partial epilepsy, with or without secondary generalisation; MedDRA version: 9.0Level: LLTClassification code 10065336

• Registration Number: EUCTR2006-003834-14-DE
• Lead Sponsor: Desitin Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-11
• Study Completion: 2009-03-10
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 < 100 kg.
5. 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 barrier methods with or without oral contraceptives)
6. Stable regimen of = 2 concomitant AEDs (vagus nerve stimulator included) during the baseline period; lamotrigine dose may be adjusted at baseline.
7. Ethnic origin: Caucasian.
8. Subjects capable of complying with the study stipulations.
9. Patients who have provided written informed consent to participate in this study.
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>adverse events.