Status:
TERMINATED
Perampanel in Focal Status Epilepticus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Epilepticus; Status, Focal Motor
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
In spite of the use of various antiepileptic drugs, the SE, generalized or focal, are refractory to the treatment in around 25 % of the cases. There is therefore a need to develop new therapy with nov...
Eligibility Criteria
Inclusion
- 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)
- 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.
- Affiliation to a French social security system (recipient or assign) excluding "Aide Médicale" Etat (AME)
Exclusion
- Known severe liver (Factor V \<50 %) or kidney (glomerular filtration rate : 15-29 ml/min/1,72 m2) insufficiency
- Women with known or clinically detected pregnancy
- Patients with known allergies to perampanel or to any of the excipients mentioned in the summary of product characteristics(SmPC)
- Patients with postanoxic status
- Patients in coma (Glasgow\<8)
- Patients with motor events for which a nonepileptic psychogenic origin is suspected
- Patients whose status epilepticus is linked to a pathological condition, such as trauma, who needed immediate surgery
- Known current treatment by perampanel
- Known galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)
- Known participation in another trial with medication and/or previously included in PEPSI study
Key Trial Info
Start Date :
November 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04309721
Start Date
November 2 2022
End Date
November 13 2023
Last Update
December 14 2023
Active Locations (10)
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1
Urgences, CHU Lille (Hôpital Roger Salengro)
Lille, France, 59037
2
Neuro-physiologie clinique, CHU Lille (Hôpital Roger Salengro)
Lille, France
3
Réanimation polyvalente, CHU (Hopital Roger Salengro)
Lille, France
4
Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital
Paris, France, 75013