Epilepticus; Status, Focal Motor Clinical Trial
— PEPSIOfficial title:
Efficacy of add-on PEramPanel in Focal Motor Status Epilepticus
| Verified date | December 2023 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Randomized controlled trial on focal motor status epilepticus (SE), studying the add-on efficacy of the enteral administration of perampanel (PER) to a conventional intravenous antiepileptic drug.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | November 13, 2023 |
| Est. primary completion date | November 2, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Patients aged 18 years or above, including the protected adults with a focal motor status epilepticus, defined by prominent clinically objective focal motor symptoms (clonic, tonic, myoclonic, adversive or oculoclonic), lasting for more than 10 minutes before any treatment or repeated focal motor seizures during this period (= 4 seizures in 10 min) 2. The focal motor status continues (or patients show = 2 focal motor seizures) 5 minutes or more after the beginning of administration of benzodiazepines. The delay between administration of benzodiazepines and randomization must not exceed 6 hours. 3. Affiliation to a French social security system (recipient or assign) excluding "Aide Médicale" Etat (AME) Exclusion Criteria: 1. Known severe liver (Factor V <50 %) or kidney (glomerular filtration rate : 15-29 ml/min/1,72 m2) insufficiency 2. Women with known or clinically detected pregnancy 3. Patients with known allergies to perampanel or to any of the excipients mentioned in the summary of product characteristics(SmPC) 4. Patients with postanoxic status 5. Patients in coma (Glasgow<8) 6. Patients with motor events for which a nonepileptic psychogenic origin is suspected 7. Patients whose status epilepticus is linked to a pathological condition, such as trauma, who needed immediate surgery 8. Known current treatment by perampanel 9. Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) 10. Known participation in another trial with medication and/or previously included in PEPSI study |
| Country | Name | City | State |
|---|---|---|---|
| France | Neuro-physiologie clinique, CHU Lille (Hôpital Roger Salengro) | Lille | |
| France | Réanimation polyvalente, CHU (Hopital Roger Salengro) | Lille | |
| France | Urgences, CHU Lille (Hôpital Roger Salengro) | Lille | |
| France | Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital | Paris | |
| France | Hôpital Pitié Salpêtrière - ICU | Paris | |
| France | Neurologie et Neurovasculaire, GH Paris Saint Joseph | Paris | |
| France | Réanimation Polyvalente, GH Paris Saint Joseph | Paris | |
| France | S.A.U, Pitié-Salpêtrière Hospital | Paris | |
| France | Accueil des Urgences, Centre Hospitalier de Versailles - André Mignot | Versailles | |
| France | Neurologie, Centre Hospitalier de Versailles - André Mignot | Versailles | Ile De France |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Administration or not of either (i) an additional second-line antiepileptic drug, either intravenous or orally, or (ii) a third-line (anesthetic drug) | 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 | Within de 6 hours after the perampanel or placebo administration | |
| Secondary | Seizure cessation | Seizure cessation is defined clinically by the interruption of any epileptic movements (clonic, tonic or myoclonic) | at 3 hours and 6 hours after the perampanel or placebo administration | |
| 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 | Altered consciousness is defined as Glascow Coma Scale (GCS) <8 | at 3 hours and 6 hours after the perampanel or placebo administration | |
| Secondary | Duration of hospitalization | Duration of overall hospitalization (ICU/step down/standard hospitalisation) and duration of hospitalization in ICU/step down unit, both censored 14 days after randomisation | From randomization untill 14 days after the administration of perampanel or placebo | |
| Secondary | Rate of patient with seizure recurrence | 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 |
From hour 3 until hour 24 after the administration of perampanel or placebo | |
| Secondary | Rate of patient with status epilepticus recurrence, in patients with seizure cessation | 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. | From hour 3 until hour 24 after the administration of perampanel or placebo | |
| Secondary | Rate of patients with secondary generalized seizures | Secondary generalized seizures is defined as convulsive tonic or clonic bilateral seizure lasting less than 5 minutes | From hour 0 until hour 24 after the administration of perampanel or placebo | |
| Secondary | Progression to a convulsive generalized status epilepticus | 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 | From hour 0 until hour 24 after the administration of perampanel or placebo | |
| 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 | 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). | Up to 14 days (end of hospitalization) or 14 days if the patient is still hospitalized | |
| Secondary | Global neurological state at the end of the study period | 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 | Up to 14 days (end of hospitalization) or 14 days if patient is still hospitalized | |
| 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 | Several etiological categories will be defined :
acute symptomatic versus remote symptomatic versus cryptogenic causes identification of a brain lesion versus not |
At H0 (below or above the median of SE duration | |
| 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) |