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

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

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