14 results
This study, a three-phased cross-over study, aims to define a proper formulation for oral and oromucosal melatonin by investigating the Tmax and relative bioavailability derived from melatonin levels in salivary samples of healthy volunteers after…
To compare the treatment effect of Circadin 2/5 mg to that of placebo on sleep maintenance (TST) as assessed by the Sleep and Nap Diary after 13 weeks of double-blind treatment.
Primary ObjectivesThe primary objectives of this study are to evaluate the analgesic effect size over 12 weeks of several doses and dosage regimens of JNJ-42160443 compared with placebo in subjects with moderate to severe, chronic, low back pain (…
Primary Objectives• To evaluate the analgesic efficacy of JNJ-42160443 (1, 3, and 10 mg; administered as a single, subcutaneous injection every 28 days) in reducing average pain intensity, in subjects with postherpetic neuralgia neuralgia • To…
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…
A phase Ib / II randomized study of BI 836845 in combination with exemestane and everolimus versus exemestane and everolimus alone in women with locally advanced or metastatic breast cancer.With following objectives:Phase Ib part: To determine the…
The general aim of the present study is to investigate, in a longitudinal-experimental design, the effects of melatonin treatment and light therapy in children on sleep, health, and various psychosocial, behavioural, and cognitive outcomes. A second…
To assess the efficacy of idebenone, compared to placebo, in improving or delaying the loss of respiratory function in patients with DMD
- To gather long-term data on the safety and tolerability of idebenone inFriedreich*s Ataxia- To explore the effect of idebenone after longer term administration onneurological symptoms and signs as assessed by the InternationalCooperative Ataxia…
Does melatonin by improving sleep parameters improve quality of life of hemodialysis patients?
Primary:* To assess the long-term safety of idebenone in DMD patients who completed the SIDEROS study.Secondary:* To describe the long-term evolution of respiratory function in idebenone-treated DMD patients who completed the SIDEROS study,…
In this study the best treatment of DSPS will be investigated by comparison of existing treatments. We will investigate is patients with ADHD and DSPS have less favorable blood values for biomarkers of chronic diseases in comparison with norm values…
Primary Objective- To demonstrate dose proportionality between 1 mg and 5 mg of PedPRM (Neurim Pharmaceuticals Ltd.) following a single oral dose in healthy male and female volunteers (treatment A and C), under fed conditions.Secondary Objectives-…
This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…