12 results
Evaluation of the effects of octreotide LAR in head-and-neck paraganglioma on:1. tumor volume 2. catecholamine produktion 3. clinical and biochemical parameters
Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…
Primary: To evaluate the efficacy of ontamalimab in inducing remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:* To evaluate the…
Primary: To evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:*…
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®).
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…
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…
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.
Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…
To evaluate the safety and tolerability of long term treatment with ontamalimab in subjects with moderate to severe UC or CD.
To investigate whether oral esketamine is non-inferior to ECT in achieving treatment response on depression severity in NTRD.