The effects of a flexible visual acuity-driven ranibizumab treatment regimen in age-related macular degeneration: outcomes of a drug and disease model.

Purpose: Differences in treatment responses to ranibizumab injections observed within trials involving monthly (MARINA and ANCHOR studies) and quarterly (PIER study) treatment suggest that an individualized treatment regimen may be effective in neovascular age-related macular degeneration. In the present study, a drug and disease model was used to evaluate the impact of an individualized, flexible treatment regimen on disease progression.

Methods: For visual acuity (VA), a model was developed on the 12-month data from ANCHOR, MARINA, and PIER.

Combination therapy from the regulatory perspective.

For a combination regimen to receive regulatory approval, it must provide some incremental advantage over a previous standard. Although this advantage is typically a greater likelihood of achieving a clinically relevant endpoint, there are others. For example, the additive effects of two agents may allow each to be employed in relatively low doses, improving tolerability.

Oxcarbazepine pharmacokinetics and tolerability in children with inadequately controlled epilepsy.

This two-part, open-label study evaluated the pharmacokinetics, safety, and tolerability of oxcarbazepine as combination therapy in 112 children 2 to 12 years old with inadequately controlled epilepsy. Part I was a pharmacokinetic study in children stratified by age (2-5 years and 6-12 years) and randomized to receive a single oxcarbazepine dose of 5 mg/kg or 15 mg/kg. Mean specific AUC and t(1/2) values of the active metabolite (MHD) were approximately 30% lower in younger children compared with older children, regardless of dose.

Combining entacapone with levodopa/DDCI improves clinical status and quality of life in Parkinson's Disease (PD) patients experiencing wearing-off, regardless of the dosing frequency: results of a large multicentre open-label study.

The efficacy of entacapone and its impact on patient quality of life (QOL) was investigated in an open-label study of 899 patients with idiopathic Parkinson's Disease (PD) experiencing wearing-off fluctuations. Patients were divided into 3 groups (3, 4 or 5 doses daily) based on their current levodopa dosage frequency. Patients received 200 mg entacapone with each levodopa/dopa-decarboxylase inhibitor (DDCI) dose, while continuing their same levodopa/DDCI dosage regimen for 4 weeks.

Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder.

Objective: To evaluate the safety and efficacy of extended-release methylphenidate with a bimodal profile using SODAS technology (Ritalin LA ) compared with placebo in children aged 6-14 years with attention deficit hyperactivity disorder (ADHD).

Method: This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study in children meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD. Following titration and a 1-week placebo washout period, patients were randomized to 2 weeks of double-blind treatment with either Ritalin LA (10-40 mg/day) or placebo.

Selfotel in acute ischemic stroke : possible neurotoxic effects of an NMDA antagonist.

Background And Purpose: Based on neuroprotective efficacy in animal models, we evaluated the N-methyl D-aspartate antagonist Selfotel in patients with ischemic stroke, after doses up to 1.5 mg/kg were shown to be safe in phase 1 and phase 2a studies.

Methods: Two pivotal phase 3 ischemic stroke trials tested the hypothesis, by double-blind, randomized, placebo-controlled parallel design, that a single intravenous 1.

Carbamazepine in agitation and aggressive behaviour following severe closed-head injury: results of an open trial.

Ten patients presenting agitation and anger outbursts at various stages following a severe closed head injury, were treated in a prospective open trial with carbamazepine, with doses ranging from 400 to 800 mg per day, during 8 weeks. Group analysis demonstrated a statistically significant improvement of a score made up from six target items from the neurobehavioural rating scale. Improvement mainly concerned irritability and disinhibition.

Comparative effects of low and high doses of clomipramine and placebo in panic disorder: a double-blind controlled study. French University Antidepressant Group.

This study was designed to explore the dose-response relationship for clomipramine in patients with panic disorder, with or without agoraphobia. After 1 week of single-blind placebo pretreatment, 180 such patients were assigned to a multicentre placebo-controlled comparison of the effects of high and low doses of clomipramine, and were followed up for 8 weeks. In alleviating anxiety and panic disorder, both clomipramine doses were more efficacious than placebo for panic disorder and, to a lesser degree, for phobia.

[Controlled study of treatment of residual depression by clomipramine versus placebo].

The choice of a new treatment strategy for a patient suffering from residual depression in sometimes difficult; in reality, any change in the prescription involves a risk of losing any benefit, even partial, that has recently been obtained; consequently, can one be sure that a new antidepressant treatment will be beneficial? To attempt to find the answer to this question, the Laboratories Ciba-Geigy have conducted a controlled study versus placebo to evaluate the efficacy of clomipramine in residual depression which has been progressing for more than a year. 207 patients were pre-included in the 7-day wash-out phase and treated with placebo. During this period, a clinical examination and laboratory work-up made it possible to exclude patients with a curable cause of partial resistance to antidepressants (e.

Influence of lateralized sensorimotor and neuropsychological activities on electroencephalographic spectral power.

In order to test the effect of 'lateralized' sensorimotor and neuropsychological activities on EEG spectral power (P), we recorded EEGs over the right and left central regions with 3 different derivations C5P3/C6P4, C5Cz/C6Cz, and C5 ears-linked (EL)/C6EL in 14 young, right-handed men who underwent ten 2 min sequences including 4 during rest (3 with eyes closed (EC), 1 with eyes open (EO], and 6 during tasks reputed to involve preferentially the left (Le) or the right (Ri) hemisphere, i.e., pure left and pure right motor activity of the hand (EC), pure neuropsychological tasks consisting in lexical followed by spatial form analysis and finally mixed (neuropsychological and motor) EC tasks consisting in writing followed by left hand object recognition.

The influence of vigilance states on paroxysmal EEG activities and clinical seizures in children.

We studied the relationships between clinical variables and those related to the states of vigilance in 18 cases of benign partial epilepsy with centro-temporal spike-waves, 22 cases of definite symptomatic partial epilepsy, and 16 cases of undetermined partial epilepsy. The time of day during which the seizures appeared and the paroxysmal activity densities during non-REM and REM sleep are not distributed differently among the 3 electro-clinical types. However, the benign epilepsy with centro-temporal spikes group had more patients with sleep-sensitive paroxysmal activities.