123 results
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…
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…
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…
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 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.
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…
To investigate effect of tizanidine ER 12 mg on simulated driving performance, cognitive and psychomotor functions compared with placebo, tizanidine IR 8 mg (two 4 mg doses given 6.5 hours apart) and active-control in healthy subjects
The primary objectives for Part 1:-To determine the recommended Phase II dose of RO5424802 to be used in Part 2 of the study-To evaluate the safety and tolerability of 600mg and 900mg doses of RO5424802 administered twice daily to subjects with…
Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…
The co-primary objectives of this study are as follows:* To evaluate the effect of presatovir (GS-5806) on RSV viral load and development of lower respiratory tract complication (LRTC) in RSV positive autologous or allogeneic HCT recipients with…
To investigate the effect of modafinil (200 mg) and caffeine (300 mg) on vigilance in low, medium and high caffeine consumers during the circadian trough in order to determine the best pharmacological agent to target fatigue.
The purpose of the study is to investigate how quickly and to what extent BIM23B065 is distributed, metabolized (broken down) and excreted from the body, and what the main route of excretion from the body is (urine or feces); this is called…
Please refer to protocol, section 1.2 "Rationale"
To investigate the efficacy of testosterone enhanced exposure therapy for social anxiety disorder.
To demonstrate that treatment with avelumab in combination with standard of care (SOC) CRT is superior to SOC CRT alone in prolonging progression-free survival (PFS) in front-line patients with high-risk (as defined in Inclusion Criterion 2),…
To evaluate the efficacy of HDM-SPIRE in the reduction of symptoms and the use of allergy rescue medication associated with HDM allergy in subjects with clinically relevant symptoms.
Objectives: To compare PFS using RECIST 1.1 as assessed by BICR and OS in PD-L1 positive subjects and all subjects between the following treatment comparisons:(a) Pembrolizumab + chemotherapy versus chemotherapy(b) Pembrolizumab versus…
The primary objective of this study is to compare microglia activation as measured with proton Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are randomised to CBD and those randomised to placebo. Secondary…