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

Information source: University Hospital of Grenoble
Information obtained from ClinicalTrials.gov on May 09, 2007
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy; Drug Resistant

Intervention: levetiracetam (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Hospital of Grenoble

Official(s) and/or principal investigator(s):
Louis Maillard, Dr, Principal Investigator, Affiliation: University Hospital of Nancy
Serge CHASSAGNON, Dr, Principal Investigator, Affiliation: University Hospital of Strasbourg
Cecile SABOURY, Dr, Principal Investigator, Affiliation: University Hospital of Strasbourg
Edouard HIRSH, Dr, Principal Investigator, Affiliation: University Hospital of Strasbourg
William SZHURAJ, Dr, Principal Investigator, Affiliation: University Hospital of Lille
Philippe DERAMBURE, Dr, Principal Investigator, Affiliation: University Hospital of Lille
Jerome PETIT, Dr, Principal Investigator, Affiliation: La Teppe Institution
Vincent TAREL, Dr, Principal Investigator, Affiliation: Regional Hospital of Chambery
Dominique ROSENBERG, Dr, Principal Investigator, Affiliation: University Hospital of Clermont-Ferrand
Helene CATENOIX, Dr, Principal Investigator, Affiliation: University Hospital of Lyon
Philippe RYVELIN, Dr, Principal Investigator, Affiliation: University Hospital of Lyon
Philippe CONVERS, Dr, Principal Investigator, Affiliation: University Hospital of St Etienne
Pierre THOMAS, Dr, Principal Investigator, Affiliation: University Hospital of Nice

Overall contact:
Laurent VERCUEIL, Dr, Phone: 0476765488, Email: LVercueil@chu-grenoble.fr

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.

Clinical Details

Official title: Rapid Oral Treatment of Cluster Epileptic Seizures. Efficacy Assessment of Levetiracetam in Cluster Seizures.

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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.

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Laurent VERCUEIL, Dr, Phone: 0476765488, Email: LVercueil@chu-grenoble.fr

Neurology department, Nice, Alpes de Haute provence 06002, France; Recruiting
Pierre Thomas, Dr
Veronique Bourg, Dr, Sub-Investigator

Etablissement la Teppe, Tain l'Hermitage, Drome 26600, France; Recruiting
Jerome Petit, Dr

Neurology department, Nancy 54035, France; Recruiting
Louis Maillard, Dr
Louis Maillard, Dr, Principal Investigator

Neurology department, Strasbourg 67091, France; Recruiting
Edouard Hirsch, Pr
Cecile Saboury, Dr, Principal Investigator

Neurology department, Grenoble, Isere 3043, France; Recruiting
Laurent Vercueil, Dr
Laurent Vercueil, Dr, Principal Investigator

Neurology department, St Etienne, Loire 42055, France; Recruiting
Philippe Convers, Pr

Neurology department, Lille, Nord 59037, France; Recruiting
Derambure Philippe, Pr
Szhuraj William, Dr, Sub-Investigator

Neurology department, Clermont-Ferrand, Puy de Dome 63003, France; Recruiting
Dominique Rosenberg, Dr
Dominique Rosenberg, Dr, Principal Investigator

Neurology department, Lyon, Rhone 69000, France; Recruiting
Ryvlin Phillipe, Pr
Helene Catenoix, Dr, Sub-Investigator

Neurology Department, chambery, Savoie 73000, France; Recruiting
Viencent TAREL, Dr
Vincent Tarel, Dr, Principal Investigator

Additional Information

Related publications:

Haut SR, Shinnar S, Moshe SL. Seizure clustering: risks and outcomes. Epilepsia. 2005 Jan;46(1):146-9.

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.

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.

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.

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.

Starting date: February 2007
Ending date: April 2008
Last updated: April 19, 2007

Page last updated: May 09, 2007

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