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

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.

Conditions

• Epilepsy
• Drug Resistant

Interventions

DRUG

levetiracetam

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• UCB Pharma

  collaborator INDUSTRY

• University Hospital, Grenoble

  lead OTHER

Principal Investigators

• Louis Maillard, Dr · Central Hospital, Nancy, France

• Serge CHASSAGNON, Dr · University Hospital of Strasbourg

• Cecile SABOURY, Dr · University Hospital of Strasbourg

• Edouard HIRSH, Dr · University Hospital of Strasbourg

• William SZHURAJ, Dr · University Hospital of Lille

• Philippe DERAMBURE, Dr · University Hospital of Lille

• Jerome PETIT, Dr · La Teppe Institution

• Vincent TAREL, Dr · Regional Hospital of Chambery

• Dominique ROSENBERG, Dr · University Hospital, Clermont-Ferrand

• Helene CATENOIX, Dr · University Hospital of Lyon

• Philippe RYVELIN, Dr · University Hospital of Lyon

• Philippe CONVERS, Dr · University Hospital of St Etienne

• Pierre THOMAS, Dr · University Hospital of Nice

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-28

Primary Completion

2008-04-30

Completion

2008-04-30

Countries

• France

Study Locations