80 results
The primary objective of the study is to assess the safety and tolerability of BMS-708163 in patients with prodromal Alzheimer*s disease.
· Evaluate the efficacy and safety of BF2.649 administered by escalating doses and followed by 5-week stable doses in narcoleptic patients with excessive daytime sleepiness (EDS) as compared to placebo.· Evaluate the efficacy and safety of BF2.649…
To assess the efficacy of idebenone, compared to placebo, in improving or delaying the loss of respiratory function in patients with DMD
Evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy attacks.Evaluate the additive/synergistic effect of the combination of BF2.649 and Modafinil on excessive daytime sleepiness (EDS…
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
To establish the MTD and/or recommended phase II dose of the coadministration of LDE225 and INC424 in patients with MF, who have not previously received therapy with a JAK inhibitor
Primary:To demonstrate the efficacy of LMTM as assessed by the change from Baseline on:* Addenbrooke*s Cognitive Examination Revised (ACE-R)* Symptomatic effect as reflected by the Functional Activities Questionnaire (FAQ)* Disease-modifying effect…
The primary objective is to evaluate the long-term safety and tolerability of BRV at individualized doses up to a maximum of 200mg/day in focal epilepsy subjects.The second objective is to evaluate the maintenance of efficacy of BRV over time.
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: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…
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…
Primary:The primary objective of the study is to evaluate the efficacy of oral administration of dexpramipexole 150 mg twice daily compared to placebo for 12 months in subjects with ALS.Secondary:The secondary objectives of the study are to evaluate…
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…
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…
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 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.
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…
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…