Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus (NCT01150331) | Clinical Trial Compass
CompletedPhase 3
Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus
France203 participantsStarted 2009-07
Plain-language summary
Compare the efficiency of the association, first line, the intravenous levetiracetam and the intravenous clonazepam, in that of a monotherapy of clonazepam intravenous in the pre-hospital treatment of tonicoclonic generalised status epilepticus.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria :
* Age ≥ 18 years
* Patient taken care by a prehospital medical team participating in the study
* Diagnosis of tonicoclonic generalized status epilepticus confirmed on the spot by a physician of the team.
Exclusion criteria :
* Parent or the reliable person indicated by the patient present not giving its agreement for the inclusion
* Pregnancy clinically detectable or known for close relations at the time of the status epilepticus
* tonicoclonic generalized status epilepticus after anoxia post cardiac arrest
* Patient having already received another treatment for the same episode of status epilepticus
* Patient having already participated in the study during a previous episode of status epilepticus
* Patient in "latent" status epilepticus. Definition : patient in the coma having epileptic demonstrations (CLONISMS MYOCLONISMS) small or invalid, contrasting with permanent generalized electric seizures on the EEG
* Patient presenting certain diagnosis of pseudo name psychogenic seizure
* Patient whose neurological status requires an immediate surgery (traumatism)
* Patient having a hyper-responsiveness about the levetiracetam or about the other by-products of pyrrolidone or an one of the excipients
* Patient having a hyper-responsiveness about the clonazepam, about the benzodiazepins or about one of the other constituents of the product
* Patient under medical guardianship
* Not membership in a schema of medical assurance.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient's percentage having stopped convulsing in the 15 minutes following the injection. The stop of the crisis is defined as the stop of all epileptic movements (myoclonic, clonic or tonic)