Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)

This study has been terminated.
(recruitment recruitment recruitment recruitment difficulties)
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
UCB, Inc.
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00376766
First received: September 14, 2006
Last updated: March 11, 2008
Last verified: April 2007

September 14, 2006
March 11, 2008
February 2007
Not Provided
Ratio of patients who are free of seizure between H3 and H24 in both groups.
Same as current
Complete list of historical versions of study NCT00376766 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Epilepsy
  • Drug Resistant
Drug: levetiracetam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
April 2008
Not Provided

Inclusion Criteria:

  • Age from 18 to 65
  • Drug resistant epilepsy, partial seizure
  • Epilepsy diagnosed for more than 2 years
  • Epilepsy treated for more than 1 year with no change of treatment in the month before the enrolment
  • Onset of cluster seizure in the 24 hours before enrolment
  • For women : effective contraception
  • Affiliation to the French social security

Exclusion Criteria:

  • Inability to tolerate levetiracetam, likely poor compliance
  • Patient taking antiepileptic treatment (benzodiazepine) in addition to current treatment during the last 48h00.
  • Patient taking 1g/day of levetiracetam with Creatinin clearance < 50ml/min
  • Patient taking 2g/day of levetiracetam with Creatinin clearance < 80ml/min
  • Patient taking more than 2g/day of levetiracetam
  • Hepatic or cardiovascular pathology
  • Progressive psychiatric pathology
  • Degenerative neurologic disease
  • Cluster seizure due to an acute symptomatic reason
  • Disorder of consciousness
  • Suspicion of status epilepticus or rapid evolution to status epilepticus
  • Suspicion of psychogenic nonepileptic seizure
  • Pregnant woman or nursing woman
  • Suicidal thoughts
  • Incapacity to give consent, minor patient
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00376766
DTCIC 05 24
No
Not Provided
University Hospital, Grenoble
  • Institut National de la Santé Et de la Recherche Médicale, France
  • UCB, Inc.
Principal Investigator: Louis Maillard, Dr University Hospital, 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
University Hospital, Grenoble
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP