Overview

Perampanel in Focal Status Epilepticus

Status:
Not yet recruiting

Trial end date:
2022-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

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 "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