Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.|
- Ratio of patients who are free of seizure between H3 and H24 in both groups.
- Items 1,2,3 of the Clinical Global Impression scale.
- Side effects during the study.
- Time between H0 and the last seizure.
- Type and ratio of epileptic fit between H0 and H24.
- Number of seizures occured between H3 and H10, H10 and H17, H17 and H24, corresponding to the half-time of the treatment (7 hours).
- Description of therapeutic adaptation at 1 month after patient enrolment.
|Study Start Date:||February 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376766
|Nice, Alpes de Haute provence, France, 06002|
|Etablissement la Teppe|
|Tain l'Hermitage, Drome, France, 26600|
|Grenoble, Isere, France, 3043|
|St Etienne, Loire, France, 42055|
|Lille, Nord, France, 59037|
|Clermont-Ferrand, Puy de Dome, France, 63003|
|Lyon, Rhone, France, 69000|
|Chambery, Savoie, France, 73000|
|Nancy, France, 54035|
|Strasbourg, France, 67091|
|Principal Investigator:||Louis Maillard, Dr||Central Hospital, Nancy, France|
|Principal Investigator:||Serge CHASSAGNON, Dr||University Hospital of Strasbourg|
|Principal Investigator:||Cecile SABOURY, Dr||University Hospital of Strasbourg|
|Principal Investigator:||Edouard HIRSH, Dr||University Hospital of Strasbourg|
|Principal Investigator:||William SZHURAJ, Dr||University Hospital of Lille|
|Principal Investigator:||Philippe DERAMBURE, Dr||University Hospital of Lille|
|Principal Investigator:||Jerome PETIT, Dr||La Teppe Institution|
|Principal Investigator:||Vincent TAREL, Dr||Regional Hospital of Chambery|
|Principal Investigator:||Dominique ROSENBERG, Dr||University Hospital of Clermont-Ferrand|
|Principal Investigator:||Helene CATENOIX, Dr||University Hospital of Lyon|
|Principal Investigator:||Philippe RYVELIN, Dr||University Hospital of Lyon|
|Principal Investigator:||Philippe CONVERS, Dr||University Hospital of St Etienne|
|Principal Investigator:||Pierre THOMAS, Dr||University Hospital of Nice|