15 results
To evaluate the effect of intranasal esketamine 84 mg on cognition, and duration of cognitive effects (if present), as assessed using a computerized test battery (Cogstate®).
Primary Objective: To characterize the effect of repeat-dose administration of brigatinib 180 mg QD on the single-dose PK of midazolam.Other Objectives:Safety: To assess the safety and tolerability of brigatinib in patients with ALK-positive or ROS1…
Primary ObjectiveTo evaluate the effect of a single 84-mg dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal esketamine on same-day driving performance as assessed by…
The purpose of this study is to find out how safe and effective a new drug called bimekizumab is for long-term use in treating hidradenitis suppurativa. Bimekizumab (hereafter referred to as *the study drug*) has been approved by the health…
Phase 1:The primary objective of this trial is to investigate whether oral esketamine is non-inferior to ECT after eight weeks of individually optimized treatment, in participants with NTRD.Phase 2:To compare the efficacy of maintenance oral…
Primary objectiveThe primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe HS.Secondary objectiveThe secondary objective of this study is to assess the safety, tolerability, immunogenicity,…
Primary Objectives:To determine the efficacy of brigatinib, as evidenced by confirmed objective response rate (ORR), in patients with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.…
Objective: Primary objective: To determine pharmacokinetic profiles of an esketamine oral thin film with 50 or 100 mg esketamine; Secondary objective: (1) To determine the pharmacodynamic profile of an esketamine oral thin film containing 50 or 100…
In this open-label extension study, we look at how safe and effective the new medicinal product called bimekizumab (hereafter called the *study drug*) is for long-term treatment of hidradenitis suppurativa. Open label means that both you and your…
The primary objective is to investigate whether pharmacological conditioning with S(+)-ketamine compared to pharmacological conditioning with placebo medication reduces pain sensitivity in patients with FMS.
The primary objective of this open-label extension (OLE) study is to assess the long-term safety and tolerability of bimekizumab administered over a period of up to 112 weeks.
Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously every 4 weeks (sc Q4W) compared to placebo in the treatment of subjects with active nr-axSpA.Secondary objectives:The…
Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously (sc) every 4 weeks (Q4W) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).…
Primary Objective:The primary objective of this study is to compare the efficacy of bimekizumab administered scfor 16 weeks versus secukinumab at achieving complete clearance (PASI100) in subjects withmoderate to severe chronic plaque PSO.The…
To investigate whether oral esketamine is non-inferior to ECT in achieving treatment response on depression severity in NTRD.