Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1 participants
INTERVENTIONAL
2022-11-02
2023-11-13
Brief Summary
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Detailed Description
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New antiepileptic drugs emerge as potential drugs for SE. Perampanel (PER) is a new drug available for add-on therapy in patients with a focal epilepsy. The mechanism of action of this drug is original, as it is a non-competitive α-amino-3-hydroxy-5-methylisoxazole-4-propionate (AMPA) receptor antagonist. Several studies suggested that AMPA-mediated glutamatergic transmission plays an important rule during the SE.
In this study the investigator will focus on patients suffering from early focal motor SE, for several reasons:
(i) There is no randomized controlled double-blind trial in this population, and therefore no evidence to help physicians.
(ii) The investigator aims to perform a trial on early SE, after failure of only one drug (a benzodiazepine, recommended as first line treatment), in order to properly evaluate the effect of the tested drug (add-on of perampanel).
(iii) The perampanel is available only for oral administration. Focal SE usually does not affect the vital prognosis and can be treated less aggressively. Use of oral loading doses of antiepileptic drugs is frequent, and therapies may be changed or adapted in the time-frame of hours or days.
(iv) Patients with a focal SE, presenting motor symptoms, can be included without the need of an EEG. Similarly, the primary end-point, cessation of the motor events, does not require specific exam, and can also be done clinically.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Perampanel
immediate enteral administration of Perampanel, 12 mg
Perampanel
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
Placebo
immediate enteral administration of placebo
Placebo
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
Interventions
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Perampanel
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
Placebo
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Affiliation to a French social security system (recipient or assign) excluding "Aide Médicale" Etat (AME)
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Vincent Navarro, DDS,PhD
Role: PRINCIPAL_INVESTIGATOR
Groupe Hospitalier Pitié-Salpêtrière
Locations
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Urgences, CHU Lille (Hôpital Roger Salengro)
Lille, , France
Neuro-physiologie clinique, CHU Lille (Hôpital Roger Salengro)
Lille, , France
Réanimation polyvalente, CHU (Hopital Roger Salengro)
Lille, , France
Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital
Paris, , France
Hôpital Pitié Salpêtrière - ICU
Paris, , France
Réanimation Polyvalente, GH Paris Saint Joseph
Paris, , France
Neurologie et Neurovasculaire, GH Paris Saint Joseph
Paris, , France
S.A.U, Pitié-Salpêtrière Hospital
Paris, , France
Accueil des Urgences, Centre Hospitalier de Versailles - André Mignot
Versailles, , France
Neurologie, Centre Hospitalier de Versailles - André Mignot
Versailles, Île-de-France Region, France
Countries
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Other Identifiers
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2019-000882-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P160949J
Identifier Type: -
Identifier Source: org_study_id