KECOM (Keppra add-on bij patienten met epilepsie)
A
rondomised observer-blind first add-on comparative study in patients with
partial seizures.
Protocol
number 2002-1-Keppra
inclusion criteria
-
age between 18 and 70 years, with a minimum weight of 45 kg
-
late symptomatic or cryptogenic localisation-related epilepsy with
partial-onset seizures, with or without secondary generalization
-
steady-state treatment with CBZ monotherapy for at least 28 days
-
uncontrolled on CBZ or requiring another AED for other reasons
(subjective complaints of side-effects).
Evidence of a progressive
cerebral lesion, degenerative disorder, malignancy or a history with malignancy
in the past 5 years; cognitive impairment that could interfere with the
cognitive testing procedure; females who do not practice reliable contraception;
documented history with generalized status epilepticus in the past three months;
unstable medical disease (i.e. cardiovascular, hepatic, renal, gynaecologic,
musculoskeletal, gastrointestinal, metabolic, endocrine) in the last 2 years; a
history of alcohol or drug abuse, of psychiatric disorder requiring
electro-convulsive therapy, chronic use of major tranquillisers (neuroleptics,
antidepressants, or MAO inhibitors) in the past 6 months; subjects who are
schizophrenic or have exhibited any psychotic symptomatology; regularly
treatment with antihistamines, metoclopramide or CNS-active compounds, or an
experimental drug during the past 30 days; a history with poor compliance of
antiepileptic treatment.
Flow chart: :
|
Neurological investigation; visit of the trial nurse + tests en blood
will be taken |
1 or 2 weeks later: start with keppra or valproate |
4 weeks after the start with the new medication: visit of the trial
nurse |
12 weeks after the start with the new medication: - visit of the neurologist and the trial nurse - tests and blood will be taken |
During the last interview we will advice how to proceed with treatment
after the trial |