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A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel Group
Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of
Subjects with Moderate to Severely Active Crohn*s Disease

To evaluate the safety and efficacy of intravenously administered FFP104 in subjects with active Crohn*s disease following repeat doses of FFP104.

A Phase II Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of VS 6063 in Subjects with Malignant Pleural Mesothelioma

Primary Efficacy Objectives• To compare the overall survival (OS) in subjects with malignant pleural mesothelioma receiving VS-6063 or placebo.• To compare the progression free survival (PFS) in subjects with malignant pleural mesothelioma receiving…

A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder

Subjects randomized to the placebo treatment are unlikely to benefit from the study. However, OAB is not a life-threatening disease and it is not expected that a 12 to 15 week exposure to placebo treatment will have a negative impact on disease…

Transplantation of faeces in ulcerative colitis; restoring nature*s homeostasis

Primary objective: to study the effect of faecal transplantation in a phase II randomised placebo controlled design on simple clinical colitis activity index (SCCAI) and endoscopic Mayo score. Secondary objective: to study intra individual changes…

A Phase 2A, Double-blind, Placebo-controlled, Randomized
Study to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male patients with increased Cardiometabolic Risk

To determine the safety and efficacy (in increasing insulin sensitivity) of TRC 150094 once daily dosing for 4 weeks in male subjects with increased cardiometabolic risk.To evaluate the effect of TRC150094 on hepatic fat and metabolic parameters.To…

A double blind, randomized, parallel, study to assess the effects of aliskiren/amlodipine and amlodipine monotherapy on ankle foot volume (AFV) in patients naïve to trial drugs with mild to moderate hypertension.

Primary objective:To assess and compare the effects of aliskiren/amlodipine and amlodipine on pedal edema after 4 weeks of treatment as measured by ankle foot volume (AFV) (water displacement method) in patients with mild to moderate hypertension.…

Vitamin D treatment effect on retinal nerve fiber loss after optic neuritis

Primary objective:- To determine whether high dose vitamin D treatment in optic neuritis can reduce axonal loss as measured by OCT. Secondary objectives: - To investigate whether the occurrence of a second attack (defining clinically definite MS) is…

Low pressure pneumoperitoneum during laparoscopic donornephrectomy: a pilot study

The feasability of a randomized trial studying the advantageous effects of low-pressure pneumoperitoneum during laparoscopic donornephrectomy will be assessed.

First International Randomized Study in MAlignant Progressive Pheochromocytoma and Paraganglioma

Primary objective: To determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous…

Combining N-of-1 trials to estimate population clinical effectiveness of drugs using Bayesian hierarchical modeling. The case of Mexilitin for patients with Non-Dystrophic Myotonia.

(voor meer details zie CMO-protocol paragraaf 2: Objectives) Primary Objective: The objective of this project is to further refine N-of-1 trial methodology, and explore whether Bayesian analysis of multiple N-of-1 trials can serve as a sufficient…

A randomised sequential trial of Lithium in amyotrophic lateral sclerosis

To determine the effect of lithium treatment (plasma levels between 0,4-0,8 mEq/liter) versus placebo - in addition to riluzole 2dd 50 mg - on reaching a clinical endpoint in patients with ALS.

A double-blind, randomized, placebo-controlled, single-center, two-way cross-over study with KH176 in patients with the mitochondrial DNA tRNALeu(UUR) m.3243A>G mutation and clinical signs of mitochondrial disease

Objectives: Primary Objective1. To evaluate the effect of KH176 on gait (Gaitrite®) parameters: step-length and variability in step-time and step-width in patients with a m.3243A>G mutationSecondary Objectives2. To explore the effect of KH176…

Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery

To assess safety and tolerability of EA-230 in patients undergoing cardiac surgery with cardiopulmonary bypass.To assess the anti-inflammatory effects of EA-230 in patients with systemic inflammation following cardiac surgery. To assess the effects…

A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis

The primary objective of this study is to evaluate in patients suffering from diffuse cutaneous SSc (DcSSc) the effect of 800mg and 1200mg IVA337 daily on the skin compared to placebo. The modified Rodnan Skin Score (MRSS) will be used to determine…

European phase-II clinical trial evaluating efficacy of low dose rhIL-2 in patients with recently diagnosed type 1 diabetes

Primary objective1. To evaluate efficacy of ILT-101 for the preservation of residual pancreatic β cells function2. To select the optimal regimen of administration of ILT-101.Secondary objectivesTo assess:1. Tregs expansion after an induction period…

Smartphone based Monitoring and cognition Modification Against Recurrence of Depression

In the current protocol we describe 2 work packages in which we aim to perform: A. >=2 focus-groups to gauge acceptability of the smartphone-app (WP1); B. follow-up remitted patients with recurrent MDD for 1.5 year while the background app (…

The effects of Vitamin K2 supplementation on the progression of Coronary Artery Calcification

The primary objective of this study is to determine whether daily oral supplementation of Vitamin K2 will slow down or arrest CAC-progression after 12 and 24 months in comparison to placebo in patients with established CAC. Secondary, we wish to…

STEPWISE Parkinson: A smartphone based, titrated exercise solution for patients with Parkinson*s disease in daily life

The aim of this study is to investigate whether a smartphone app can increase physical activity in PDpatients for a long period of time (one year). The secondary aim is to test the potential effects of an increase in physical activity on physical…

A multi-national, multi-centre, double-masked, placebo-controlled proof of concept trial to evaluate the safety and efficacy of oral soraprazan in Stargardt disease

Primary objective:To evaluate the efficacy of soraprazan in reducing the amount of lipofuscin inRPE cells of subjects with Stargardt disease by assessing the change inquantitative auto-fluorescence (qAF8) from baseline to after treatment…

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn*s disease with an option for open-label treatment extension (CALDOSE-2)

Primary objective• To determine the optimal dose of IMU-838 to induce symptomatic remission (based on stool frequency [SF] and abdominal pain [AP], as assessed in the Crohn*s Disease Activity Index [CDAI] patient reported outcome [PRO]-2) in…