16 results
To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.
The primary objective is to evaluate the efficacy of Namisol® in the management of behavioural disturbances in patients with dementia. Secondary objectives are:- To evaluate the efficacy of Namisol® on secondary outcome measures, such as quality of…
The primary aim of this study is to investigate the analgesic effect of perioperatively administered Namisol® to reduce postsurgical pain on the day of surgery and in the first five days after major abdominal surgery. A secondary aim is to…
To document the long term safety and efficacy of sarilumab added to DMARDs.
In this study, we explore the correlation between baseline intratumoral CD8+ cell density and objective response rate (ORR) as well as other biomarker parameters in subjects with unresected stage IIIB to IVM1c melanoma treated with talimogene…
Primary:- To assess the effect of TAK-861 on EDS as measured by sleep latency from the MWT.Secondary:- To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score. - To evaluate the safety and tolerability of…
To evaluate the long-term safety and tolerability of TAK-861.
Primary:The primary objective of this study is to determine whether DMF taken over 12 months is effective in reducing MS-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in subjects with…
To investigate the analgesic profile of different classical and non-classical analgesic compounds using a battery of pain tests (PainCart) in healthy subjects compared to a negative control.Secondary:- Investigate the association between subjective…
Part IPrimary objectiveTo investigate the pharmacokinetics of the main metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of 3 different controlled release tablet formulations (FP187: V1, V2B, and V3B) and…
The objectives of the study are to assess the safety and tolerability of ascending doses of SAR422459 in patients with Stargardt macular disease and to evaluate the possible biological activity of SAR422459.
Primary ObjectiveThe primary objective is to investigate the PK of the MMF * the main metabolite of DMF * following administration of a delayed-and slow-release tablet formulation (FP187-GC) and the marketed enteric-coated delayed release…
Primary Objective:To evaluate the efficacy potential, safety and tolerability of intravenously administered ANXV, in ascending doses, and two different dosing regimens, in patients with confirmed moderate to severe COVID-19.Secondary Objectives:To…
Primary objective: Our key objective is to determine if a cannabinoid manipulation is more effective than a glucocorticoid manipulation to facilitate fear memory extinction retention in an experimental model of exposure therapy in healthy…
Primary ObjectivesEvaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants with cholangiocarcinoma with FGFR2 rearrangement. Secundary ObjectivesEvaluate the efficacy of pemigatinib versus…
Primary objective is: * To determine the overall survival (OS) benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA.Secundary objectives are:* To determine the PFS benefit of PAG treatment…