Prior Clinical Studies Research Articles

Spinal Arachnoiditis

The diagnostic and therapeutic courses of 68 patients with the discharge diagnosis of spinal arachnoiditis were reviewed. The combination of oil myelography and spinal surgery was the probable cause of arachnoiditis in almost all cases. The clinical presentation featured leg pain (90%), low-back pain (80%), and sphincter disturbance (25%). Motor, sensory, and reflex changes were present in two thirds of the cases, with a majority having defects attributable to bilateral or multiple root level involvement. Specific analysis of previous operative procedures cerebrospinal fluid (CSF) studies, and myelographic patterns did not disclose any consistent correlation with the clinical presentation. Results are interpreted in light of prior clinical and experimental studies on the reaction of the meninges to trauma and myelography.

Attentiveness in behaviorally deviant and nondeviant children: I. Auditory vigilance performance.

The present study examined the vigilance performance of 16 behaviorally deviant and 16 nodeviant children and suggested that the vigilance paradigm might serve as a basis for a standardized test of continuous attention in children. The deviant and nondeviant children performed an auditory vigilance task administered on two separate occasions, 4 days apart. Performance during the first administration of the task deteriorated significantly for the deviant children as a function of time but not for the nondeviant ones. This finding was consistent with several prior clinical studies with children and suggested that the behaviorally deviant children were relatively less able to maintain a continuous level of attention. In addition, the vigilance procedure yielded relatively high test-retest reliability coefficients for both groups of children as well as performance which tended to vary as a function of chronological age.

Erythema Nodosum and Pustular Ringworm

<h3>Objective:</h3> Evaluate PK and generate preliminary safety and efficacy data for perampanel oral suspension given as adjunctive therapy in pediatric patients (aged ≥1 to &lt;24 months) with epilepsy in Study 238 (NCT02914314). <h3>Background:</h3> Perampanel is a once-daily oral antiepileptic drug (AED) for partial-onset seizures and primary generalized tonic-clonic seizures. <h3>Design/Methods:</h3> Study 238 is a multicenter, open-label Phase II study comprising the Pretreatment and Treatment Phases (Core Study), and the Extension Phase. Planned enrollment is ≥16 patients with evaluable PK data. The primary endpoint is perampanel PK during the Maintenance Period of the Core Study. Secondary (safety) endpoints include incidence rate of treatment-emergent adverse events (TEAEs) and clinical laboratory parameters. Perampanel is initiated at 0.5 mg/day and titrated to a maximum dose of 12 mg/day (patients taking non–enzyme-inducing AEDs [EIAEDs]) or 16 mg/day (patients taking EIAEDs) based on clinical response and tolerability. <h3>Results:</h3> As of July 26, 2018, 11 patients were enrolled and 9 (2 aged &gt;6 to ≤12 months and 7 aged &gt;12 to &lt;24 months) entered into the Core Study. Of these, 7 have completed the Core Study, 1 is ongoing, and 1 discontinued due to inadequate therapeutic effect. Limited PK data, based on dose-normalized plasma concentrations, from 7 patients (aged &gt;6 to &lt;24 months; 1 taking EIAEDs) suggested that perampanel exposure was within the range of patients aged ≥2 years. TEAEs were experienced by 8 (88.9%) patients, and treatment-related TEAEs occurred in 5 (55.6%) patients. The most common TEAEs were upper respiratory tract infection (55.6%), pyrexia (44.4%), nasopharyngitis (33.3%), and somnolence (33.3%). <h3>Conclusions:</h3> Preliminary data suggest that perampanel is safe and well tolerated in pediatric patients with epilepsy aged &gt;6 to &lt;24 months and perampanel exposure is comparable with patients aged ≥2 years. The safety profile is consistent with prior clinical studies. Enrollment is ongoing. <b>Funding:</b> Eisai Inc. <b>Disclosure:</b> Dr. Renfroe has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai, Livanova, Ipsen. Dr. Rozentals has nothing to disclose. Dr. Aluri has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai. Dr. Umetsu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai. Dr. Ma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai. Dr. Laurenza has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai and Takeda. Dr. Ngo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai.