Perampanel in Focal Status Epilepticus

NCT04309721 | Terminated Phase 3

• 2 other identifiers: P160949J2019-000882-19
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 10

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.

Conditions

Epilepticus; Status, Focal Motor

Keywords

Perampanel; Placebo; Antiepileptic drug

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Seizure cessation

  at 3 hours and 6 hours after the perampanel or placebo administration

• Time to seizure cessation

  within the 6 hours after the administration of perampanel or placebo

• The need for endotracheal intubation

  within the 24 hours after the administration of perampanel or placebo

• Percentage of patients with altered consciousness

  at 3 hours and 6 hours after the perampanel or placebo administration

• Duration of hospitalization

  From randomization untill 14 days after the administration of perampanel or placebo

Study Arms (2)

Perampanel

EXPERIMENTAL

immediate enteral administration of Perampanel, 12 mg

Drug: Perampanel

Placebo

PLACEBO COMPARATOR

immediate enteral administration of placebo

Drug: Placebo

Interventions

Perampanel DRUG

Single-dose of Perampanel 12 mg film-coated tablet, will be given orally in patients with status epilepticus that do not involve the oral and pharyngeal musculatures. In alternative, perampanel will be administered by a nasogastric feeding tube, a procedure which has been recently reported to be safe and tolerated in patients with generalised status epilepticus

Also known as: Experimental group

Perampanel

Placebo DRUG

Single-dose of placebo of Perampanel, administered orally. Placebo of perampanel will be given orally, in patients with status epilepticus that do not involve the oral and pharyngeal musculatures. In alternative, Placebo of perampanel will be administered by a nasogastric feeding tube, a procedure which has been recently reported to be safe and tolerated in patients with generalised status epilepticus

Also known as: Control group

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (10)

Urgences, CHU Lille (Hôpital Roger Salengro)

Lille, 59037, France

Location

Neuro-physiologie clinique, CHU Lille (Hôpital Roger Salengro)

Lille, France

Location

Réanimation polyvalente, CHU (Hopital Roger Salengro)

Lille, France

Location

Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

Hôpital Pitié Salpêtrière - ICU

Paris, 75013, France

Location

Réanimation Polyvalente, GH Paris Saint Joseph

Paris, 75014, France

Location

Neurologie et Neurovasculaire, GH Paris Saint Joseph

Paris, France

Location

S.A.U, Pitié-Salpêtrière Hospital

Paris, France

Location

Accueil des Urgences, Centre Hospitalier de Versailles - André Mignot

Versailles, France

Location

Neurologie, Centre Hospitalier de Versailles - André Mignot

Versailles, Île-de-France Region, 78157, France

Location

MeSH Terms

Interventions

perampanel; Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Vincent Navarro, DDS,PhD

  Groupe Hospitalier Pitié-Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: March 16, 2020
• Study Start: November 2, 2022
• Primary Completion: November 2, 2022
• Study Completion: November 13, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

FR (10)