Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376766
Status:
TERMINATED
Last Update Posted:
2015-05-28
First Post:
2006-09-14
Brief Title:
Clinical Trial TROCC Quick Oral Treatment of Cluster Epileptic Seizures
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Rapid Oral Treatment of Cluster Epileptic Seizures Efficacy Assessment of Levetiracetam in Cluster Seizures
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment recruitment recruitment recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None