8 results
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…
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®).
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…
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…
Primary objectives Phase I: To determine the recommended phase 2 dose (RP2D) of the lapatinib-trametinib combination in patients with KRASm NSCLC Phase II: To determine the progression free survival of the lapatinib-trametinib combination compared…
Primary: The co-primary objectives of this study are* to compare independently adjudicated progression-free survival (PFS) following treatment with neratinib pluscapecitabine versus lapatinib plus capecitabine in patients with HER2-positive (HER2+)…
Primary Objective: Phase I dose escalationThe main objective of the phase I part is to determine safety and the recommended phase II dose (RP2D) of the triple combination.Phase IIThe main objective of the phase II part is to determine efficacy of…
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.