Trial · NCT04309721
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Administration or not of either (i) an additional second-line antiepileptic drug, either intravenous or orally, or (ii) a third-line (anesthetic drug) | Within de 6 hours after the perampanel or placebo administration | Administration or not of either (i) an additional second-line antiepileptic drug, either intravenous or orally, or (ii) a third-line (anesthetic drug), within the 6 hours following study drug (perampanel or placebo) administration |
| Secondary | Seizure cessation | at 3 hours and 6 hours after the perampanel or placebo administration | Seizure cessation is defined clinically by the interruption of any epileptic movements (clonic, tonic or myoclonic) |
| Secondary | Time to seizure cessation | within the 6 hours after the administration of perampanel or placebo | |
| Secondary | The need for endotracheal intubation | within the 24 hours after the administration of perampanel or placebo | |
| Secondary | Percentage of patients with altered consciousness | at 3 hours and 6 hours after the perampanel or placebo administration | Altered consciousness is defined as Glascow Coma Scale (GCS) \<8 |
| Secondary | Duration of hospitalization | From randomization untill 14 days after the administration of perampanel or placebo | Duration of overall hospitalization (ICU/step down/standard hospitalisation) and duration of hospitalization in ICU/step down unit, both censored 14 days after randomisation |
| Secondary | Rate of patient with seizure recurrence | From hour 3 until hour 24 after the administration of perampanel or placebo | Seizure recurrence is defined as focal motor seizure lasting less than 10 minutes, between hour 3 and hour 24 after the administration of perampanel or placeb. Recurrence is defined by reappearance of epileptic movements after a period of at least one hour of seizure cessation |
| Secondary | Rate of patient with status epilepticus recurrence, in patients with seizure cessation | From hour 3 until hour 24 after the administration of perampanel or placebo | Status epilepticus recurrence is defined as focal motor seizure lasting 10 minutes or more, or repeated focal motor seizures (≥4 seizures in 10 min), between hour 3 and hour 24 after the administration of perampanel or placebo. |
| Secondary | Rate of patients with secondary generalized seizures | From hour 0 until hour 24 after the administration of perampanel or placebo | Secondary generalized seizures is defined as convulsive tonic or clonic bilateral seizure lasting less than 5 minutes |
| Secondary | Progression to a convulsive generalized status epilepticus | From hour 0 until hour 24 after the administration of perampanel or placebo | Convulsive generalized status epilepticus is defined as convulsive tonic or clonic bilateral seizure lasting more than 5 minutes or more, or 2 or more seizures in 5 minutes without recovery of consciousness between the seizures |
| Secondary | Mortality rate at the end of the study period | Up to 14 days (end of hospitalization) or 14 days if the patient is still hospitalized | |
| Secondary | Glasgow Outcome Scale score at the end of the study period | Up to 14 days (end of hospitalization) or 14 days if the patient is still hospitalized | Glasgow Outcome Scale (GOS) is 5 values score from 1 (death) to 5 (resumption to normal life; there may be minor neurologic and/or psychological deficits). |
| Secondary | Global neurological state at the end of the study period | Up to 14 days (end of hospitalization) or 14 days if patient is still hospitalized | The neurological state of patients will be evaluated for comparison with that before status epilepticus. Three states will be distinguished: unchanged, new neurological deficit or death |
| Secondary | Number of adverse events and their severity | from randomization until to 14 days after the administration of perampanel or placebo | |
| Secondary | Subgroup analysis of the primary and secondary outcomes measure according to the etiology | At H0 (below or above the median of SE duration | Several etiological categories will be defined : * acute symptomatic versus remote symptomatic versus cryptogenic causes * identification of a brain lesion versus not |
| Secondary | Subgroup analysis of the primary and secondary outcomes measure according to duration of status epilepticus | At H0 (below or above the median of SE duration | |
| Secondary | Subgroup analysis of the primary and secondary outcomes measure according to type of conventional antiepileptic drug administrated | At H0 (below or above the median of SE duration) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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