Status; Epilepticus, Tonic-clonicPhase 3SAMU-KEPPRANCT01150331
Study of Antiepileptic Drug in Generalised Convulsive Status Epilepticus
A Phase 3 study testing Levetiracetam/Clonazepam in people with Status; Epilepticus, Tonic-clonic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status; Epilepticus, Tonic-clonic
- What is being tested?
- Levetiracetam/Clonazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus
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.
Read the detailed description
At this time, the prehospital treatment of the status epilepticus use some molecule ("FOSPHENYLOINE") with large contra-indications. In this case the physician is not able to know the past medical history of the patient, the biological examinations and so he can not decide which molecules he can use.
The levetiracetam is a knowledge medication in the epilepsy since more than twenty years. One of specificity of the levetiracetam is to be able to be used in all situations (no clinical or biological contre-indication). This molecule seems like to be very interesting to be used in prehospital system.
The goal of this study is to evaluate the association levetiracetam / clonazepam in first line in the prehospital treatment of the status epilepticus
- Conditions
- Status; Epilepticus, Tonic-clonic
- Being tested
- Levetiracetam/Clonazepam, Clonazepam/Placebo levetiracetam IV
- Keywords
- status epilepticus, generalised convulsive status epilepticus, first line treatments, double-blind randomized controlled trial, prehospital treatment
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam/ClonazepamDrug
Also called Association of two anti-epileptic drugs in first line
Association of two anti-epileptic drugs in first line
Clonazepam/Placebo levetiracetam IVDrug
Also called Association of placebo to an active comparator (clonazepam)
Association of placebo to an active comparator (clonazepam)
| Study group | Role | What they receive |
|---|---|---|
| Clonazepam + levetiracetam | Experimental | Clonazepam IV 1 mg+ levetiracetam IV 2500 mg Receives: Drug: Levetiracetam/Clonazepam |
| Clonazepam + placebo | Active comparator | Clonazepam IV 1 mg + placebo levetiracetam IV Receives: Drug: Clonazepam/Placebo levetiracetam IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 15 minutes
Secondary outcomes (13)
Period between the first injection and the clinical stop of the convulsion
Measured: up to 15 minutes
Period between the first injection and the presence of signs of awakening
Measured: up to three days
Time of hospitalization
Measured: up to 15 days
Patient's percentage having received the second injection of clonazepam to T5 min
Measured: 5 minutes
Patient's percentage having received an injection of second anticonvulsivant to T15 min
Measured: 15 minutes
Patient's percentage presenting signs of awakening to T35 min
Measured: 35 minutes
Patient's percentage having been intubated for the general anesthesia
Measured: 35 minutes
Score of glasgow coma scale for the patients with no signs of awakening to T35 and to the arrival of the hospital
Measured: up to 35 minutes
Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up
Measured: up to 15 days
Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital
Measured: up to 15 days
Frequency of adverse events and their severity
Measured: up to 15 days
Frequency of respiratory, hemodynamic and cardiac occurence of complications
Measured: up to 15 days
Analysis of the main criteria of efficiency by sous groups according to the etiology of the generalised tonic-clonic status epilepticus and according to this duration during the therapeutic clinical care
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Status; Epilepticus, Tonic-clonicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Pierre Carli, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150331
- Sponsor's protocol ID
- P070704
- Acronym
- SAMU-KEPPRA
- Status last verified
- Jan 2026
- First submitted
- 23 Apr 2010
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Navarro V, Dagron C, Elie C, Lamhaut L, Demeret S, Urien S, An K, Bolgert F, Treluyer JM, Baulac M, Carli P; SAMUKeppra investigators. Prehospital treatment with levetiracetam plus clonazepam or placebo plus clonazepam in status epilepticus (SAMUKeppra): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2016 Jan;15(1):47-55. doi: 10.1016/S1474-4422(15)00296-3. Epub 2015 Nov 28.
PubMed 26627366Navarro V, Dagron C, Demeret S, An K, Lamhaut L, Bolgert F, Baulac M, Carli P. A prehospital randomized trial in convulsive status epilepticus. Epilepsia. 2011 Oct;52 Suppl 8:48-9. doi: 10.1111/j.1528-1167.2011.03236.x.
PubMed 21967362
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Levetiracetam Intravenous in Association With Clonazepam Versus Clonazepam Alone in Prehospital Care of Generalised Tonicoclonic Status Epilepticus
- ClinicalTrials.gov ID
- NCT01150331
- Acronym / sponsor ID
- SAMU-KEPPRA / P070704
- Conditions
- Status; Epilepticus, Tonic-clonic
- Keywords
- status epilepticus, generalised convulsive status epilepticus, first line treatments, double-blind randomized controlled trial, prehospital treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jul 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At this time, the prehospital treatment of the status epilepticus use some molecule ("FOSPHENYLOINE") with large contra-indications. In this case the physician is not able to know the past medical history of the patient, the biological examinations and so he can not decide which molecules he can use.
The levetiracetam is a knowledge medication in the epilepsy since more than twenty years. One of specificity of the levetiracetam is to be able to be used in all situations (no clinical or biological contre-indication). This molecule seems like to be very interesting to be used in prehospital system.
The goal of this study is to evaluate the association levetiracetam / clonazepam in first line in the prehospital treatment of the status epilepticus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clonazepam + levetiracetam | Experimental | Drug: Levetiracetam/ClonazepamClonazepam IV 1 mg+ levetiracetam IV 2500 mg |
| Clonazepam + placebo | Active comparator | Drug: Clonazepam/Placebo levetiracetam IVClonazepam IV 1 mg + placebo levetiracetam IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam/ClonazepamAlso: Association of two anti-epileptic drugs in first lineAssociation of two anti-epileptic drugs in first line | Drug | Clonazepam + levetiracetam |
| Clonazepam/Placebo levetiracetam IVAlso: Association of placebo to an active comparator (clonazepam)Association of placebo to an active comparator (clonazepam) | Drug | Clonazepam + placebo |
Primary outcome
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)
Time frame: 15 minutes
13 secondary outcomes
Period between the first injection and the clinical stop of the convulsion
Time frame: up to 15 minutes
Period between the first injection and the presence of signs of awakening
Time frame: up to three days
Time of hospitalization
Time frame: up to 15 days
Patient's percentage having received the second injection of clonazepam to T5 min
Time frame: 5 minutes
Patient's percentage having received an injection of second anticonvulsivant to T15 min
Time frame: 15 minutes
Patient's percentage presenting signs of awakening to T35 min
Time frame: 35 minutes
Patient's percentage having been intubated for the general anesthesia
Time frame: 35 minutes
Score of glasgow coma scale for the patients with no signs of awakening to T35 and to the arrival of the hospital
Time frame: up to 35 minutes
Patient's percentage having had a recurrence of epileptic seizure during the hospital follow-up
Time frame: up to 15 days
Patient's percentage presenting convulsions or signs of awakening to the arrival to the hospital
Time frame: up to 15 days
Frequency of adverse events and their severity
Time frame: up to 15 days
Frequency of respiratory, hemodynamic and cardiac occurence of complications
Time frame: up to 15 days
Analysis of the main criteria of efficiency by sous groups according to the etiology of the generalised tonic-clonic status epilepticus and according to this duration during the therapeutic clinical care
Time frame: up to 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 26627366Navarro V, Dagron C, Elie C, Lamhaut L, Demeret S, Urien S, An K, Bolgert F, Treluyer JM, Baulac M, Carli P; SAMUKeppra investigators. Prehospital treatment with levetiracetam plus clonazepam or placebo plus clonazepam in status epilepticus (SAMUKeppra): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2016 Jan;15(1):47-55. doi: 10.1016/S1474-4422(15)00296-3. Epub 2015 Nov 28.
- Derived from this study: PubMed 21967362Navarro V, Dagron C, Demeret S, An K, Lamhaut L, Bolgert F, Baulac M, Carli P. A prehospital randomized trial in convulsive status epilepticus. Epilepsia. 2011 Oct;52 Suppl 8:48-9. doi: 10.1111/j.1528-1167.2011.03236.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Carli, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam/Clonazepam in people with Status; Epilepticus, Tonic-clonic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.