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.
Conditions
Interventions
Product Name: Levetiracetam
Product Code: ucb L059
Pharmaceutical Form: Tablet
INN or Proposed INN: levetiracetam
CAS Number: 102767-28-2
Current Sponsor code: ucb L059
Other descriptive name: (S)-a-e
Sponsors
Birthe Pedersen
Eligibility
Sex/Gender
All
Inclusion criteria
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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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
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. o However, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: • 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: o Occurrence of a status epilepticus o Unacceptable side effect o Or 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;Primary end point(s): • Percentage of patients seizure free during the 12 months | — |
Countries
Sweden
Outcome results
None listed