Status:
TERMINATED
Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
UCB Pharma
Conditions:
Epilepsy
Drug Resistant
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00376766
Start Date
February 1 2007
End Date
April 1 2008
Last Update
May 28 2015
Active Locations (10)
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1
Neurology department
Nice, Alpes de Haute provence, France, 06002
2
Etablissement la Teppe
Tain-l'Hermitage, Drome, France, 26600
3
Neurology department
Grenoble, Isere, France, 3043
4
Neurology department
Lille, Nord, France, 59037