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Sponsors and Collaborators: |
University Hospital, Grenoble Institut National de la Santé Et de la Recherche Médicale, France UCB |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00376766 |
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.
Condition | Intervention | Phase |
---|---|---|
Epilepsy Drug Resistant |
Drug: levetiracetam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures. |
Estimated Enrollment: | 112 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | April 2008 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Neurology department | |
Nancy, France, 54035 | |
Neurology department | |
Strasbourg, France, 67091 | |
France, Alpes de Haute provence | |
Neurology department | |
Nice, Alpes de Haute provence, France, 06002 | |
France, Drome | |
Etablissement la Teppe | |
Tain l'Hermitage, Drome, France, 26600 | |
France, Isere | |
Neurology department | |
Grenoble, Isere, France, 3043 | |
France, Loire | |
Neurology department | |
St Etienne, Loire, France, 42055 | |
France, Nord | |
Neurology department | |
Lille, Nord, France, 59037 | |
France, Puy de Dome | |
Neurology department | |
Clermont-Ferrand, Puy de Dome, France, 63003 | |
France, Rhone | |
Neurology department | |
Lyon, Rhone, France, 69000 | |
France, Savoie | |
Neurology Department | |
chambery, Savoie, France, 73000 |
Principal Investigator: | Louis Maillard, Dr | University Hospital of Nancy |
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 |
Study ID Numbers: | DTCIC 05 24 |
Study First Received: | September 14, 2006 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00376766 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Cluster seizure seizure clustering repetitive seizure |
Drug resistant epilepsy Levetiracetam keppra |
Signs and Symptoms Epilepsy Seizures Neurologic Manifestations |
Central Nervous System Diseases Etiracetam Brain Diseases |
Nootropic Agents Therapeutic Uses Nervous System Diseases |
Central Nervous System Agents Pharmacologic Actions Anticonvulsants |