Patients with a focal motor status epilepticus
Conditions
Interventions
Trade Name: Fycompa
Product Name: Fycompa
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PERAMPANEL
CAS Number: 380917-97-5
Other descriptive name: PERAMPANEL
Concentration unit: mg mill
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
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 after the beginning of administration of benzodiazepines, 3. Affiliation to a French social security system (recipient or assign) excluding AME Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 332 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 332
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the add-on efficacy of enteral administration of perampanel (versus placebo) to the conventional second line intravenous antiepileptic drug, on seizure cessation, measured within the 2 and 3 hours after the administration of perampanel or placebo (between H2 and H3), in benzodiazepine-resistant focal motor status epilepticus. ;Secondary Objective: To evaluate the add-on efficacy of enteral administration of PER to the conventional 2nd line IV antiepileptic (AE) drug, on the: •Rate of seizure cessation •Time to seizure cessation •Time to seizure cessation,without the use of an additional 2nd line IV AE drug •Need for additional 2nd line AE drugs to control the SE •Need for endotracheal intubation for general anesthesia and for disorder of consciousness •% of patients with altered consciousness •Duration of overall hospitalization and in ICU/step down unit •Rate of seizure recurrence and SE recurrence in patients with seizure cessation of at least 1h •% of patients with secondary generalized seizures and number of secondary generalized seizures •Progression to a convulsive generalized SE •Mortality rate, the GOS and return to previous neurological state •Number of adverse events and their severity •% of patients with seizure cessation within 1h after the administration of the conventional 2nd line IV AE drug;Primary end point(s): No Seizure or seizure cessation within the 2 and 3 hours after the perampanel or placebo administration (H2 to H3) : - defined clinically by the absence or cessation between H2 and H3 of any epileptic movements (clonic, tonic or myoclonic) - once the seizures stop, no seizure recurrence should be observed during at least 60 minutes. - without the use of an additional second line intravenous antiepileptic drug between H0 and H3. ;Timepoint(s) of evaluation of this end point: The primary end point will rely on clinical assessment (systematic neurological observation of 2 minutes duration) at least every 15 minutes fro | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Seizure cessation from H2 to H6, H2 to H12 and H2 to H24 • Time to seizure cessation, within the 24h after the administration of perampanel or placebo, • Time to seizure cessation, within the 24h after the administration of perampanel or placebo, without the use of an additional second line intravenous antiepileptic drug •The need for additional second line antiepileptic drugs to control the status epilepticus within the 24h • The need for endotracheal intubation for general anesthesia within the 24h • The need for endotracheal intubation for disorder of consciousness within the 24h • Glascow Coma Scale (GCS; see Annex) score<8 at H3, H6, H12 and H24; measured by physician • Duration of overall hospitalization (ICU/step down/standard hospitalisation/ after care and rehabilitation) and duration of hospitalization in ICU/step down unit, both censored 14 days after randomization • Seizure recurrence, defined as focal motor seizure lasting less than 10 minutes, between H3 and H24 and time of recurrence. Recurrence is defined by reappearance of epileptic mouvements after a period of at least one hour of seizure cessation • Status epilepticus recurrence, defined as focal motor seizure lasting more than 10 minutes or repeated focal motor seizures (=4 seizures in 10 min), between H3 and H24 and time of recurrence • Secondary generalized seizures, defined as convulsive tonic or clonic bilateral seizure lasting less than 5 minutes, between H0 and H24. • Convulsive generalized status epilepticus, defined as convulsive tonic or clonic bilateral seizure lasting more than 5 minutes or 2 or more seizures in 5 minutes without recovery of consciousness between the seizures, between H0 and H24. • Vital status, Glasgow Outcome Scale score and return to previous neurological state (i.e. before focal status epilepticus) at the end of the study period (end of hospitalization or after 14 days if still hospitalized); measured by physician • Occu | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed