E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Refractory partial epilepsy, with or without secondary generalisation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065336 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the maintenance dosage where dose uptitration has to be discontinued due to adverse events. |
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E.2.2 | Secondary objectives of the trial |
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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The maintenance dosage where dose up-titration has to be discontinued due to adverse events. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the last visit of the last patient at the site where the last patient has his/her follow-up visit. (See section 9.3.3 of the study protocol) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |