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Purpose: To evaluate safety, tolerability, and seizure outcome data during long‐term treatment with once‐daily adjunctive perampanel (up to 12 mg/day) in patients with refractory partial‐onset seizures.
Methods: Study 307 was an extension study for patients completing the double‐blind phase of three pivotal phase III trials (studies 304, 305, and 306). The study consisted of two phases: an open‐label...
PurposeThree phase III studies (304 [ClinicalTrials.gov identifier: NCT00699972], 305 [NCT00699582], 306 [NCT00700310]) evaluated perampanel, an α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid (AMPA) receptor antagonist, as adjunctive therapy for refractory partial seizures. We report post hoc analyses of pooled study data by randomized dose.
MethodsPatients with partial seizures despite receiving...
Quality of life is directly related to the number and severity of adverse effects, and a successful antiepileptic medication must demonstrate a good balance between efficacy and tolerability. Perampanel is a newly licensed antiepileptic medication for the adjunctive treatment of patients (age 12 and older) with partial epilepsy with or without secondary generalization. Safety endpoints in the three...
Perampanel (PER) has been tested in three randomized placebo‐controlled prospective phase III trials as an adjunctive antiepileptic drug (AED) in adult and adolescent patients age 12 years and older who had ongoing focal epileptic seizures despite receiving one to three AEDs. Patients were randomized to once‐daily placebo or maintenance dosages of 2, 4, or 8 mg of PER daily in one trial or to dosages...
With perampanel the first‐in‐class selective alpha‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolprepionic acid (AMPA) receptor antagonist has been finally approved for add‐on treatment in patients with focal‐onset seizures. This suggests additional therapeutic potential in hitherto difficult‐to‐treat epilepsies.
Perampanel (PER) has been approved for adjunctive treatment of partial‐onset seizures in patients age 12 years and older. In Germany, PER was licensed and marketed in September of 2012. At our tertiary referral epilepsy center, a couple of difficult‐to‐treat patients were awaiting this introduction of PER; therefore, we were able to initiate treatment in many patients within a short period of time...
The antiepileptic drug (AED) perampanel is approved in ≥40 countries as adjunctive therapy for drug‐resistant partial seizures in patients with epilepsy. This post hoc analysis of pooled data from three phase III, double‐blind, randomized studies of perampanel examines between‐gender differences in perampanel efficacy and safety. Of the 1,478 subjects in the pooled analysis (719 male, 759 female),...
ObjectivePerampanel, a selective, noncompetitive α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid (AMPA) glutamate receptor antagonist, is indicated for adjunctive treatment of partial seizures in patients ≥12 years based on three phase III clinical studies. The perampanel U.S. Prescribing Information includes a boxed warning for serious psychiatric and behavioral adverse reactions. To provide...
Objective
Assess cognitive effects of adjunctive perampanel in adolescents.
Methods
In this double‐blind study (ClinicalTrials.gov identifier: NCT01161524), patients aged 12 to <18 years with partial‐onset seizures despite receiving 1–3 antiepileptic drugs were randomized (2:1) to perampanel or placebo. Perampanel was increased weekly in 2‐mg increments to 8–12 mg/day (6‐week titration; 13‐week...
ObjectiveThe noncompetitive α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid (AMPA) receptor antagonist perampanel was shown in phase III trials to be an effective and well‐tolerated adjunctive treatment for partial‐onset seizures. In adolescents, it is necessary to characterize cognitive, neuropsychological, and behavioral side effects of antiepileptic drugs (AEDs). The current analysis focuses...
Objective
To analyze occurrence of falls among patients with partial seizures, with/without secondarily generalized seizures (SGS), and primary generalized tonic–clonic seizures (PGTCS) in the perampanel phase III clinical studies.
Methods
Studies 304, 305, and 306 randomized subjects (≥12 years) with drug‐resistant partial seizures (with/without SGS) to perampanel 2, 4, 8, or 12 mg or placebo...
Objective
Perampanel (PER), a selective non‐competitive α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid (AMPA)‐receptor antagonist, exhibits broad‐spectrum anticonvulsant activity in several seizure models, but its potential disease‐modifying effects have not been investigated. Because of the relevance of AMPA receptors in epileptogenesis and psychiatric comorbidities, we studied the effects...
Objective
Perampanel (PER) was used in 12 patients with Unverricht‐Lundborg disease (ULD) to evaluate its efficacy against myoclonus and seizures.
Methods
We treated 11 patients with EPM1 mutations (6 F, 5 M, aged 13–62 years) and a 43‐year‐old man with de novo KCNC1 mutation. PER was introduced by 2 mg steps at 2–4 week intervals until 6 mg/day, with a possible dose reduction or dose increase...
Objective
The purpose of this study was to evaluate changes in health care resource utilization following the initiation of perampanel for the treatment of epilepsy in the United States.
Methods
Health care claims from Symphony Health's Integrated Dataverse database between December 2012 and November 2015 were analyzed. Patients newly initiated on perampanel, having ≥1 epilepsy (International Classification...
Objective
Perampanel (PER) is a selective noncompetitive antagonist at α‐amino‐3‐hydroxy‐5‐methyl‐4‐isoxazolepropionic acid receptors, the first of its class approved for the adjunctive treatment of partial onset seizures and generalized seizures. This study explored anti‐ictogenic and antiepileptogenic effects of PER in rats at different stages of development.
Methods
Using a rapid kindling model...
Refractory nonconvulsive status epilepticus (NCSE) occurs in 10%‐30% of patients following resuscitation after cardiac arrest. Both the optimal treatment and prognosis of postanoxic status epilepticus remain uncertain. We analyzed acute electroencephalographic changes, neurological outcome at 3 months, and adverse effects in consecutive postanoxic patients with super‐refractory NCSE treated with add‐on...
Objective
To evaluate long‐term safety/tolerability and seizure outcomes in patients with focal seizures treated with adjunctive perampanel in the open‐label extension (OLEx) Study 307 (ClinicalTrials.gov identifier: NCT00735397).
Methods
Patients could enter the OLEx after completing one of the double‐blind, phase III studies. Safety/tolerability and seizure outcomes (median percent reduction...
Status epilepticus (SE) is typically defined as a prolonged self‐sustaining seizure or repeated seizures showing an incomplete recovery between them. SE represents a medical emergency often associated with significant disability, morbidity, and mortality. Despite the clinical impact, the mechanisms underlying the transition from self‐limited seizures to protracted, medically refractory seizures are...
Perampanel is an adjunctive treatment for epilepsy that works through the direct inhibition of AMPA receptors. The same molecular mechanism has recently been shown for a fatty acid, decanoic acid, prescribed in the medium chain triglyceride ketogenic diet for the treatment of patients with drug‐resistant epilepsy. Because each compound has been proposed to act through a distinct AMPA receptor binding...
People of different ethnic or racial backgrounds may experience variations in pharmacokinetic and pharmacodynamic responses to drug therapies. Our post hoc analysis evaluated the efficacy, safety, and tolerability of perampanel in Asian and non‐Asian populations with refractory focal seizures with or without focal to bilateral tonic‐clonic (FBTC) seizures. This analysis pooled data from 4 randomized,...
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