E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-convulsive status epilepticus |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Our objectives were to assess whether IV levetiracetam could be administered safely in the treatment of non-convulsive status epilepticus, whether it was efficacous in termination non-convulsive status epilepticus fast when administered together with IV lorazepam, and whether is was efficacious in preventing relapse within 12 hours after treatment. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
We included adult male and female patients with non-convulsive SE (NCSE), and more particularly complex partial SE (CPSE) and SE in coma. NCSE was defined as a change in behaviour and/or mental status from baseline associated with EEG changes consistent with SE. We subdivided CPSE into CPSE in patients with epilepsy and CPSE de novo. We considered subtle SE as a subgroup of SE in coma. Subtle SE was defined as SE that evolved from convulsive seizures to seizures with minor motor manifestations, such as muscle twitches, tonic eye deviation and nystagmoid eye jerks, and ictal EEG changes. |
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E.4 | Principal exclusion criteria |
Simple partial SE (SPS), absence SE and postanoxic myoclonus or myoclonic status epilepticus, organic or psychogenic pseudoseizures, and coma with the following EEG patterns: periodic lateralised epileptiform discharges (PLEDs), bilateral independent periodic lateralised epileptiform discharges (BiPLEDs), periodic epileptiform discharges (PEDs), generalized periodic epileptiform discharges, stimulus-induced rhythmic periodic ictal-like discharges (SIRPIDs), and triphasic waves. Cases that were doubtful on electroclinical grounds, in whom a diagnosis of SE would only be made a posteriori after a therapeutic trial with anti-epileptic drugs, were also excluded. Prior treatment for seizures was not an exclusion criterion. Current treatment with levetiracetam was an exclusion criterion. Renal failure was not an exclusion criterion. Contraindications for administration of VPA, such as hepatitis, mitochondrial disease, pancreatitis, pregnancy and hepatic porphyria, were exclusion criteria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome was responder rate immediately after IV administration of lorazepam and before administration of valproate comparing the group that received placebo versus the group that received levetiracetam |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |