Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)
NCT ID: NCT00376766
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
112 participants
INTERVENTIONAL
2007-02-28
2008-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.
NCT00175890
Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
NCT00150748
Intravenous Levetiracetam as First-line Anticonvulsive Treatment in Patients With Non-convulsive Status Epilepticus
NCT00603135
A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
NCT01228747
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
NCT01506882
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
levetiracetam
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
UCB Pharma
INDUSTRY
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Louis Maillard, Dr
Role: PRINCIPAL_INVESTIGATOR
Central Hospital, Nancy, France
Serge CHASSAGNON, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Strasbourg
Cecile SABOURY, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Strasbourg
Edouard HIRSH, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Strasbourg
William SZHURAJ, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Lille
Philippe DERAMBURE, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Lille
Jerome PETIT, Dr
Role: PRINCIPAL_INVESTIGATOR
La Teppe Institution
Vincent TAREL, Dr
Role: PRINCIPAL_INVESTIGATOR
Regional Hospital of Chambery
Dominique ROSENBERG, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Helene CATENOIX, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Lyon
Philippe RYVELIN, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Lyon
Philippe CONVERS, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of St Etienne
Pierre THOMAS, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Nice
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurology department
Nice, Alpes de Haute provence, France
Etablissement la Teppe
Tain-l'Hermitage, Drome, France
Neurology department
Grenoble, Isere, France
Neurology department
Lille, Nord, France
Neurology department
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Neurology department
Clermont-Ferrand, Puy de Dome, France
Neurology department
Lyon, Rhone, France
Neurology Department
Chambéry, Savoie, France
Neurology department
Nancy, , France
Neurology department
Strasbourg, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Haut SR, Shinnar S, Moshe SL. Seizure clustering: risks and outcomes. Epilepsia. 2005 Jan;46(1):146-9. doi: 10.1111/j.0013-9580.2005.29004.x.
Dreifuss FE, Rosman NP, Cloyd JC, Pellock JM, Kuzniecky RI, Lo WD, Matsuo F, Sharp GB, Conry JA, Bergen DC, Bell WE. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med. 1998 Jun 25;338(26):1869-75. doi: 10.1056/NEJM199806253382602.
Mitchell WG, Conry JA, Crumrine PK, Kriel RL, Cereghino JJ, Groves L, Rosenfeld WE. An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group. Epilepsia. 1999 Nov;40(11):1610-7. doi: 10.1111/j.1528-1157.1999.tb02047.x.
Shorvon SD, Lowenthal A, Janz D, Bielen E, Loiseau P. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. European Levetiracetam Study Group. Epilepsia. 2000 Sep;41(9):1179-86. doi: 10.1111/j.1528-1157.2000.tb00323.x.
Cereghino JJ, Biton V, Abou-Khalil B, Dreifuss F, Gauer LJ, Leppik I. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology. 2000 Jul 25;55(2):236-42. doi: 10.1212/wnl.55.2.236.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DTCIC 05 24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.