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A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy

2020-01-22 12:12:55 | BioPortfolio

Summary

The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.

Study Design

Conditions

Epilepsy

Intervention

Perampanel

Status

Completed

Source

Eisai Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-22T12:12:55-0500

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Correlation of Serum Level of Perampanel (PER) to Cerebrospinal Fluid (CSF) and Brain Tissue Levels of PER

Perampanel is a drug used to treat patients with epilepsy/seizures. This study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spina...

Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civils de Lyon)

Perampanel is a non-competitive antagonist of the AMPA receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years...

Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy

The purpose of this study is to evaluate the pharmacokinetics (PK) of an oral suspension of perampanel given as an adjunctive therapy and to generate preliminary safety and efficacy data i...

A Study of Intravenous Perampanel in Japanese Participants With Epilepsy

The purpose of the study is to evaluate the safety and tolerability of perampanel administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12 milligrams per...

Effects of Perampanel on Neurophysiology Test Perimeters

This is a study to evaluate the effects of perampanel, a FDA approved drug for epilepsy, on commonly performed neurophysiology tests: electroencephalogram (EEG), somatosensory evoked poten...

PubMed Articles [1006 Associated PubMed Articles listed on BioPortfolio]

Effect of perampanel on aggression in patients with refractory focal epilepsy: A 6-month longitudinal study.

Clinical trials have demonstrated the efficacy of perampanel for the treatment of epilepsy. However, patients treated with this and other antiepileptic drugs often exhibit aggressive behaviors. We inv...

Effectiveness of perampanel as a first add-on antiepileptic drug for the treatment of partial epilepsy.

Perampanel (PER) is a newly introduced antiepileptic drug (AED) and is used in over 50 countries. In the current study, we analyzed the efficacy of PER for patients with partial epilepsy who were recr...

Efficacy and impact on cognitive functions and quality of life of perampanel as first add-on therapy in patients with epilepsy: A retrospective study.

Cognitive dysfunctions are frequent in patients with epilepsy. This comorbidity significantly alters their quality of life and plays an important role in their therapeutic management. Perampanel is a ...

Efficacy and safety of adjunctive perampanel in adolescent patients with epilepsy: Post hoc analysis of six randomized studies.

This post hoc analysis of six randomized, double-blind, Phase II and III studies evaluated efficacy and safety of adjunctive perampanel (2-12 mg/day) in adolescent patients (aged ≥12 to ≤17 ye...

Efficacy and serum concentrations of perampanel for treatment of drug-resistant epilepsy in children, adolescents, and young adults: comparison of patients younger and older than 12 years.

Perampanel (PER) is a selective, non-competitive antagonist of the alpha-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid (AMPA) receptor. In Japan, PER is approved for patients with epilepsy who a...

Medical and Biotech [MESH] Definitions

A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)

A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)

An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.

An autosomal dominant inherited partial epilepsy syndrome with onset between age 3 and 13 years. Seizures are characterized by PARESTHESIA and tonic or clonic activity of the lower face associated with drooling and dysarthria. In most cases, affected children are neurologically and developmentally normal. (From Epilepsia 1998 39;Suppl 4:S32-S41)

A subtype of epilepsy characterized by seizures that are consistently provoked by a certain specific stimulus. Auditory, visual, and somatosensory stimuli as well as the acts of writing, reading, eating, and decision making are examples of events or activities that may induce seizure activity in affected individuals. (From Neurol Clin 1994 Feb;12(1):57-8)

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