E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adjunctive therapy of partial-onset seizures in elderly patients |
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E.1.1.1 | Medical condition in easily understood language |
elderly patients suffering from epilepsy of partial-onset seizures, drug is given as an additioanl anti-epileptic drug |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10015037 |
E.1.2 | Term | Epilepsy |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 safety and tolerability of ESL as adjunctive therapy in patients aged ≥65 years with partial epilepsy, over a 26-week Treatment Period. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to explore the efficacy of ESL as adjunctive therapy in patients aged ≥65 years with partial epilepsy, over a 26-week Treatment Period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria at Screening (V1). Patient must be /have: 1) written informed consent; 2) of age 65 years or older; 3) a documented diagnosis of epilepsy for at least 12 months; 4) at least 1 partial-onset seizure (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to Screening; 5) currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to Screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS); 6) willing and able to comply with all trial requirements, in the judgement of the investigator. At Visit 2 (start of ESL treatment), patient must have: 7) at least 2 partial-onset seizures (documented in the diary) during the 8-week Baseline Period. 8) satisfactorily complied with the study requirements during the Baseline Period.
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E.4 | Principal exclusion criteria |
At Visit 1 (Screening), patients must not be / have: 1. only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures); 2. primarily generalised seizures; 3. known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia; 4. occurrence of seizures too close to count accurately; 5. history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to Screening; 6. seizures of non-epileptic origin; 7. major psychiatric disorders; 8. history of suicide attempt; 9. currently treated with oxcarbazepine; 10. previous use of ESL or participation in a clinical study with ESL; 11. known hypersensitivity to other carboxamide derivatives (e.g., oxcarbazepine, carbamazepine) or to any of the excipients; 12. uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo – or hyper thyroidism of any type; 13. second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator; 14. relevant clinical laboratory abnormalities as determined by the investigator (e.g., plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the normal range, or white blood cell count <3,000 cells/mm3); 15. calculated creatinine clearance values < 30 mL/min at screening; 16. any other condition or circumstance that, in the opinion of the investigator, may compromise the patient’s ability to comply with the study protocol; 17. received an investigational drug (or a medical device) within 3 months of Screening or is currently participating in another trial of an investigational drug (or medical device) trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is safety assessed by incidence of adverse events, clinical laboratory safety tests, ECG, blood pressure and heart rate. |
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E.5.2 | Secondary end point(s) |
Efficacy parameters are evaluated as secondary endpoints.
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Bulgaria |
Croatia |
Czech Republic |
France |
Germany |
Poland |
Portugal |
Romania |
Spain |
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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 trial will end as soon as the 100 evaluable patients have completed the trial with the last visit. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |