A

Phase 1

• Conditions: Patients with a focal motor status epilepticus; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-000882-19-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-08
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 332

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified