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 Pharma
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00376766
First received: September 14, 2006
Last updated: March 11, 2008
Last verified: April 2007
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Ratio of patients who are free of seizure between H3 and H24 in both groups.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 112
Study Start Date: February 2007
Estimated Study Completion Date: April 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376766

Locations
France
Neurology department
Nice, Alpes de Haute provence, France, 06002
Etablissement la Teppe
Tain l'Hermitage, Drome, France, 26600
Neurology department
Grenoble, Isere, France, 3043
Neurology department
St Etienne, Loire, France, 42055
Neurology department
Lille, Nord, France, 59037
Neurology department
Clermont-Ferrand, Puy de Dome, France, 63003
Neurology department
Lyon, Rhone, France, 69000
Neurology Department
Chambery, Savoie, France, 73000
Neurology department
Nancy, France, 54035
Neurology department
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Grenoble
Institut National de la Santé Et de la Recherche Médicale, France
UCB Pharma
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00376766     History of Changes
Other Study ID Numbers: DTCIC 05 24
Study First Received: September 14, 2006
Last Updated: March 11, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Cluster seizure
seizure clustering
repetitive seizure
Drug resistant epilepsy
Levetiracetam
keppra

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents

ClinicalTrials.gov processed this record on October 01, 2014