18 results
With this project we aim to determine the efficacy of anti-IL-5 treatment (mepolizumab) on virus-induced exacerbations in allergic asthma patients.Specific research questionsDoes IL-5 neutralisation:1) reduce the inflammatory response (T cell…
Primary: To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS).Secondary: Safety, tolerability, other efficacy parameters, quality of life.
The potential for risperidone to induce hyperprolactinemia in pediatric patients is well known.However, the effects of drug-induced serum prolactin elevations on growth and sexual maturation havenot been as well characterized in pediatric…
This study looks if the third generation antipsychotic aripiprazole can improve activity of the prefrontal cortex and cognitive and social function, when compared to the second generation antipsychotic risperidone.
Primary ObjectivesThe primary objective is to assess the efficacy (primarily through time to relapse) of long-acting injectable (LAI) paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over…
The primary objective of this study is to test the hypothesis that discontinuation of antipsychotics does not lead to deterioration in functioning as measured by the ABC.
Primary study objective Is the reduction of 1 to several antipsychotic antipsychotic associated with more relapse? Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is defined as: - An absolute increase of> 2 on one of…
The primary objective of this study is: To study the effect of controlled discontinuation of long-term used risperidone, for the treatment of challenging behavior, on behaviour and health. Our hypothesis is that long-term use of risperidone for…
Primary: To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) every 4 weeks versus placebo on health-related quality of life (HR-QoL) in adult and adolescent subjects with severe eosinophilic asthma. Secondary: To assess the effects of…
Primary Objective: The aim of this study is to determine the time to all-cause discontinuation of penfluridol (acemap; oral long acting neuroleptic) as compared to second-generation oral neuroleptics (olanzapine, risperidone) using an open label…
Primary: To evaluate the efficacy and safety of mepolizumab 100 mg and 300 mg subcutaneous given every 4 weeks compared to placebo on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations despite the use…
Primary: To provide extended treatment with mepolizumab to subjects with severe asthma and a history of improved disease control while receiving mepolizumab as defined by this protocol.Secondary: To collect data on long term clinical data.
Primary: To collect long term safety data.Secondary: To collect data on long term asthma control.
Primary Objective:To demonstrate that CHF 1535 twice daily is superior to Formoterol twice daily in terms of COPD exacerbations rate during 48 weeks of treatment and in terms of pulmonary function (change in pre-dose morning FEV1 from baseline to 12…
The objective of this protocol is to provide a mechanism to supply mepolizumab on an individual subject basis to eligible asthma subjects who previously participated in a GSK-sponsored mepolizumab study. During the execution of the protocol SAEs…
Primary objective:To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) compared to placebo, given every 4 weeks in liquid formulation by safety syringe (SS) to COPD participants at high risk ofexacerbations despite the use of optimized…
The study is designed to investigate why withdrawal of off-label antipsychotic drugs for behavioral problems in people with intellectual disability often fails by comparing two blinded groups (withdrawa group versus control group). This has led to…
In SPACe 2 STAR, we aim to reach further, we will test whether application of TDM in clinical practice is indeed able to reduce the number/severity of metabolic side effects, while retaining clinical effectiveness in children by means of a…