122 results
1. To demonstrate the clinical efficacy of leuco-methylthioninium bis(hydromethanesulfonate) (also known as LMTM,TRx0237) in mild Alzheimer*s disease as assessed by change from baseline on:• Alzheimer*s Disease Assessment Scale - Cognitive Subscale…
PrimaryTo estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced PNET and to assess the predictive probability of success in a…
The objective of the first two cohorts of this study is to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06372865 after a single dose across a wide exposure range up to the maximum tolerated dose or the maximum…
The primary objective of the study is to evaluate the safety and tolerability of a range of single IV and SC doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in subjects with painful lumbar radiculopathy.Secondary…
Primary objective:To assess the BE under fasted conditions of BRV 10mg, 75mg, and 100mg oral tablets of commercial formulation vs BRV 50mg oral tablet(reference) of clinical development formulation,To assess the BA under fasted conditions of BRV…
To assess the efficacy of idebenone, compared to placebo, in improving or delaying the loss of respiratory function in patients with DMD
The primary objective of the study is to assess the safety and tolerability of BMS-708163 in patients with prodromal Alzheimer*s disease.
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…
To evaluate the efficacy of BRV at doses of 100 and 200mg/day compared to PBO as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant AEDsTo assess…
The objectives of this study are:- to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in adult patients with stable coronary heart disease (CHD), CHD risk equivalents or at elevated risk for cardiovascular…
The primary objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment they received during the randomised phase of the trial.The key secondary objective is to compare the rate of withdrawal from…
PRM-151 is being developed for potential therapeutic use to prevent, treat and reduce fibrosis. This study will provide an assessment of the safety, tolerability, pharmacokinetics and pharmacodynamics of PRM-151 after administration of ascending…
Primary:The primary objective of the study is to evaluate the long-term safety profile of dexpramipexole in subjects with ALS.Secondary:The secondary objective of this study is to evaluate the longterm efficacy of dexpramipexole in this study…
The primary objective of this study is to assess the efficacy of Ecopipam to reduce self-injurious behaviors (SIB) in adults and children with Lesch-Nyhan Disease (LND) in an outpatient setting. The secondary objectives of this study are to assess…
This is the first study of MLN3897 in any disease population. It seeks to establish:1) The ability of MLN3897 to modify the signs and symptoms of RA.2)The safety and tolerability of MLN3897 in combination with MTX.3)The PK/PD profile of MLN3897 in…
The purpose of this study is to investigate how quickly and to what extent rogaratinib is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Rogaratinib will be labelled with 14 Carbon (…
Primary Objective:To evaluate the efficacy of ELX/TEZ/IVA in subjects 6 through 11 years of age with CF, heterozygous for F508del and a MF mutation (F/MF)Secondary Objectives:• To evaluate the PD of ELX/TEZ/IVA• To evaluate the safety of ELX/TEZ/IVA
Primary:To examine the effect of zolpidem on the pharmacokinetics (PK) of DS-5565 in human plasmaTo assess the safety and tolerability of concomitant administration of DS-5565 and zolpidem as defined by the adverse event (AE) profile.Secondary:To…
In this study, we will investigate what the effect of the new compound emvododstat is on how quickly and to what extent 2 approved medications (dextromethorphan in Part 1 and rosuvastatin in Part 2) are absorbed, transported, and eliminated from the…