Epilepsy Clinical Trial
Official title:
Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.
This is a double blind, placebo controlled, add-on clinical trial, of levetiracetam efficacy
and safety, in epilepsy cluster seizure.
Efficacy is evaluated in the range of 2 to 24 hours after taking the tablet. If the patient
has a seizure during this interval, he is considered as a non-respondent patient.
Seizure clustering has been defined as a series of unusual frequency of seizures with return
to baseline between events. The most common definition of cluster seizure is three seizures
per 24 hours.
The usual treatment of cluster seizure is benzodiazepin. This is recognized efficient
therapy but has many side effects. Thus it is important to develop as an new therapeutic to
improve patient care. Levetiracetam is an antiepileptic drug used in addition to other
antiepileptic drugs with less side effects than benzodiazepin.
The aim of this study is to evaluate the effectiveness and safety of levetiracetam in
epilepsy cluster seizure.
This is a double blind, placebo controlled, add-on clinical trial with two phases :
Phase 1 : Double blind phase during 24 hours (H0 to H24). After consent signature and
randomization, the patient takes two tablets of levetiracetam or placebo. If the patient has
a seizure between H3 and H24, he is considered as a non-respondent patient. If there is a
risk of rapid evolution to an statue epilepticus, the investigator can break the blind and
adapt the patient treatment accordingly.
Phase 2 : This is an open phase after H24. this phase consists of breaking the blind with
free adaption of the therapy by the investigator, and patients follow-up during 1 month.
The randomization is stratify by center. The size of randomization blocks is random because
of the systematic breaking blind after 24 hours.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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