Could a drug combo stop seizures faster? new trial tests the idea
NCT ID NCT01150331
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tested whether giving two anti-seizure drugs together (levetiracetam plus clonazepam) works better than clonazepam alone for stopping prolonged seizures in the ambulance or at home. 203 adults with generalized tonic-clonic status epilepticus took part. The main goal was to see if seizures stopped within 15 minutes after the injection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- levetiracetam and clonazepam (anti-seizure drugs)
- What this could lead to
- If it works, this could point toward a more effective first-line treatment for stopping prolonged seizures before reaching the hospital.
- What could go wrong
- This trial is completed but results are not yet widely confirmed. Adding levetiracetam may not improve outcomes over clonazepam alone, and both drugs carry risks like drowsiness or breathing problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
203 people
The number who actually took part.
- Start date
-
Jul 2009
- Finished
-
Oct 2013
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Status; epilepticus, tonic-clonic are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Necker Hospital
Paris, 75015, France