Patients with a first seizure after an ischemic cerebral infarction.
Conditions
Interventions
Product Name: Levetiracetam
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Levetiracetam
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Product Nam
Sponsors
Neurologische Klinik Bad Neustadt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years First seizure according to the actual classification of the international league against epilepsy (ILAE 1989) Seizure between 48 hours and 14 days after stroke Clinical and computertompgraphic proof of hemispherical infarction Written informed consent 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
Exclusion criteria: Patients with brain stem or cerebellar infarction Patients with progredient neurological, degenerative, malignant or other diseases which interfere with the study Patients with primary cerebral hemorrhage Patients with diseases judged as clinically relevant by the physician (cardiovascular, hepatic, renal, endocrinological, psychiatric diseases) and who interfere with the study (life expectancy below 5 years) Patients with anamnestic hints for epileptioc seizures Patient with migraine Patients with known hypersensitivity against Levetiracetam or Piracetam Participation in another clinbical trial in within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of efficacy, safety and influence on quality of life of Levetiracetam monotherapy in patients with a seizure after ischemic cerebral infarction.;Secondary Objective: Investigation of EEG and laboratory changes, Levetiracetam blood levels and course of the therapy.;Primary end point(s): Time to second seizure under Levetiracetam therapy | — |
Countries
Germany
Outcome results
None listed