| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | Newly diagnosed epilepsy patients are over 65 years. In this age group more cases are symptomatic and it is apparently another disorder than epilepsy in adults. Epilepsy in the elderly is easier to control with AEDs. But the elderly patients are on several concomitant drugs and therefore the interaction and side-effect profiles are of great importance.
| |
| MedDRA Classification |
| 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 | This is an explorative study to explore the safety profile and efficacy of levetiracetam as first line monotherapy in newly diagnosed epilepsy patients over the age of 65 years. Levetiracetam will be compared to standard treatment.
The primary objective of the trial is:
•Percentage of patients seizure free during the 12 months
| |
| E.2.2 | Secondary objectives of the trial | •Percentage of patients seizure free during the 12 months
• Time to first seizure.
•Drop out rate due to lack of efficacy and/or side effect.
•Time to withdrawal
•Retention rate after 52 weeks as a measure of combined efficacy and safety comparing LEV with VPA.
Safety endpoints:
•Withdrawal for safety reasons by the investigator such as:
oOccurrence of a status epilepticus
oUnacceptable side effect
oOr any other significant safety reason
•Side effects the first 12 weeks
•Side effects the last 24 weeks
•Need for adjustment of concomitant medication +/- hospitalisation
•Changes in body weight | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | ••Newly diagnosis of epilepsy (all types of seizures may be included) was made during the past year
•Age: 65 years and above.
•Patient must have had at least two unprovoked seizures with more than 24 hours interval in the past year and at least one seizure during the last 6 months.
or
•Patients with a known cerebral vascular events and having had the first seizure more than two weeks after the infarction was diagnosed.
and
•Must be considered as reliable and capable of adhering to the protocol.
•Written informed consent signed and dated by the patient or legally acceptable representative(s).
| |
| E.4 | Principal exclusion criteria | ••Expected life span less than 12 months.
•Previous AED treatment, i.e.:
o Patients ever treated (any indication) with LEV or VPA in the past;
o However, acute and subacute seizure treatment with drugs other than LEV or VPA is accepted with a maximum of 2 weeks duration, and if treatment was stopped at least 1 week before V1.
oHowever, acute seizure treatment with VPA iv is accepted with a maximum of 2 weeks duration, and if treatment was stopped at least 4 week before V1.
•Presence of known pseudoseizures within the last year.
•History of convulsive status epilepticus
•Known hematological parameters: absolute neutrophil counts < 1,800/mm3 and/or platelet counts < 100,000/mm3.
•Presence or history of allergy to the components of levetiracetam tablets (lactose, cornstarch, and excipients) or other pyrrolidine derivatives and valproate.
•Presence of major psychiatric illness unless the patient is on appropriate therapy
•Participation in another clinical trial with an investigational drug | |
| E.5 End points |
| E.5.1 | Primary end point(s) | | •Percentage of patients seizure free during the 12 months | |
| 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 | Information not present in EudraCT |
| 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) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| 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.8.5 | The trial involves multiple Member States | Yes |
| 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 | Information not present in EudraCT |
| 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 | |
| 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 | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
