26 results
RationaleSince gamma band activity is thought to be an important mechanism in perceptual binding and cognitive function, interest in changes in gamma band activity in neuropsychiatric disorders has grown rapidly. Changes in gamma band oscillations…
The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…
Primary: To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient*s assessment of gout pain intensity in the target joint at 72 hours post-dose (on a 0-100mm VAS). To confirm that canakinumab…
Primary: To determine whether IL-1 inhibition by Canakinumab is efficacious in treatment of Schnitzler syndrome.Secondary:1. To assess the effect of canakinumab on Schnitzler syndrome (clinical signs/symptoms and inflammatory biomarkers C-reactive…
Primary: Long term safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
Main objectiveLorazepam is frequently used as an anaesthesiological premedication before surgery in order to reduce patients resistance. Does lorazepam also improve the quality of recovery in patients scheduled for day-case-surgery?Secondary…
Primary: to demonstrate the superiority of at least one dose of canakinumab compared to placebo in reducing the risk of recurrent major cardiovascular disease events (cardiovascular death, non-fatal MI and stroke) in a population of clinically…
The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…
This study is being performed to document the effects of the new compound AZD7325 on brain functions and to investigate whether it has fewer side-effects compared lorazepam.
The main objective of this study is to investigate which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB. Other objectives are the influence of the different medication schemes on…
Aim of the study is to investigate what the influence is of insomnia on driving performance and to what extent this influence is attenuated by the use of hypnotics. Therefore, over-the-road driving performance of treated and untreated patients…
First, to estimate the cost-effectiveness of SCIT with tree pollen (TP), grass pollen (GP), and house dust mites (HDM) - the most prevalent allergies treated with SCIT - or combinations compared with UC. Second, to estimate the clinical efficacy of…
The purpose of this open-label phase III extension study is to collect additional long term safety and efficacy data on canakinumab in the treatment of SJIA from patients who qualify to roll-over into this study from the CACZ885G2305 and…
To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.Secondary Objectives * To assess the safety and tolerability of monthly 150 mg subcutaneousdoses of ACZ885 in subjects with AAA over a treatment…
Primary: The primary objective of the randomized treatment epoch and for the overall study is to demonstrate that subcutaneous canakinumab administered every 4 weeks is superior to placebo in achieving a clinically meaningful reduction of disease…
Primary Objective- To investigate the ability of TMS-EEG measures to detect effects on cortical excitability of valproic acid, levetiracetam and lorazepam in healthy subjects- To investigate the ability of TMS-EMG measures to detect effects on…
The primary objective of this study will be to determine the pharmacokinetic profile of lorazepam oral liquid 1 mg/ml in the paediatric ICU population, with specific attention for the population aged up to 12 years of age.The secondary objectives…
The objective of this study is:1. To evaluate the efficacy, safety and the tolerance of Canakinumab in 'IVIG-resistent' patients (cohort 1) and 'IVIG-naive' patients (cohort 2) with Kawasaki disease.2. To evaluate the incidence…
Primary: Safety run-in part (part 1):• Recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with pembrolizumab plus chemotherapy. Double-blind, randomized, placebo-controlled part (part 2):• Progressive free survival (PFS) between…