Search for a trial

Effect of Health games on Cognitive Function in Parkinson*s Disease

The main aim of this phase-II-proof-of-principle study is to test whether the health game AquaSnap offers improvement of cognitive impairment in PD patients with mild cognitive impairment, using an RCT. The long-term ambition is to test whether the…

Oridispersible Minitablets of Enalapril in Children With Heart Failure due to Dilated Cardiomyopathy (WP08 Trial)

Primary:To obtain paediatric pharmacokinetic data of enalapril and its active metabolite enalaprilat in paediatric patients treated with enalapril ODMTs to describe the dose exposure in the paediatric population with DCM.Secondary:1. To demonstrate…

PROSPECTIVE FASE-II TRIAL EVALUATING THE OUTCOME OF INDUCTION CHEMOTHERAPY FOLLOWED BY EXTENDED LYMPH NODE DISSECTION AND CHEMORADIATION FOR HIGH RISK INVASIVE BLADDER CANCER

- To evaluate the bladder-preservation rate after chemoradiation - To evaluate the toxicity and complications of treatment with induction chemotherapy followed by ePLND and chemoradiation

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination with Anastrozole to those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy with Abemaciclib in Combination with Anastrozole in Postmenopausal Women with Hormone Receptor Positive, HER2 Negative Breast Cancer

The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…

Efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in well differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel® 120 mg administered every 28 days.

Objectives:Primary:• To assess progression free survival (PFS) when treated with lanreotide Autogel® 120 mg administered every 14 days based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.0, and according to central review.Secondary:•…

FAST * Food Allergy Specific ImmunoTherapy
A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish

To evaluate the efficacy and safety of a SCIT-treatment with a mutant recombinant fish-parvalbumin (mCyp c1) quantified in mass units and formulated in a solution with alum, in subjects with fish-allergy.

A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (HD)

The primary objective of TRIHEP 3 is to evaluate the efficacy of triheptanoin in (i) increasing the short term energy response in the metabolic profile of the brain of early affected HD patients, as captured by 31P-MRS, and (ii) slowing atrophy in…

A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) (CLDK378A2112)

Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…

A randomized, double-blind, placebo-controlled study to compare the immune effects of multiple doses of vitamin D3 in patients with allergic rhinitis/rhino-conjunctivitis caused by birch pollen and in healthy control subjects.

The primary objective is to evaluate whether 2.5 µg VD3 analogue (Zemplar® * Abbvie) in multiple subcutaneously administered doses induces a more favourable (read: anti-inflammatory) systemic immune modulation both in general parameters and allergen…

A phase I/II *minor histocompatibility antigen UTA2-1 loaded, PD-L silenced Dendritic cell vaccination trial after allogeneic Stem Cell Transplantation to improve the safety and efficacy of Donor Lymphocyte Infusions.

Primary objectives:- To evaluate the toxicity and feasibility of a DLI-combined minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination in B cell hematological malignancies- To evaluate the effect of a DLI-combined minor H ag UTA2-1…

A Phase I/II Open Label Study in MPS IIIB Subjects to Investigate the Safety, Biodistribution, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously

To evaluate the safety and tolerability of IV administration of SBC-103 in subjects with MPS lllB, Sanfilippo B.

A placebo-controlled, double-blind, randomized trial to compare the effect of treatment on plaque burden as determined by intravascular ultrasound and to evaluate the efficacy, pharmacokinetics, safety, and tolerability of MDCO-216 given as multiple weekly infusions in subjects with a recent acute coronary syndrome.

Primary ObjectivesTo evaluate the effect of MDCO-216 treatment on the change in PAV of a target coronary artery as measured by IVUS imaging following five weekly infusions of MDCO-216 (20 mg/kg) compared with placebo in subjects with a recent ACS.…

2-STEP: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) in neonates with gestational age of *36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia

To explore the safety, tolerability and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia.

A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

In this study, we explore the correlation between baseline intratumoral CD8+ cell density and objective response rate (ORR) as well as other biomarker parameters in subjects with unresected stage IIIB to IVM1c melanoma treated with talimogene…

A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers (BET115521)

Primary:To evaluate the clinical activity of GSK525762 in NUT Midline Carcinoma and other solid tumors.Secondary:Effect of treatment with GSK525762 on tumor growth and survival. Pharmacokinetics of GSK525762. Safety.

A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation

Primary Objectives*To evaluate the safety and tolerability of multiple oral doses of GLPG1837 in subjects with CF and at least one copy of the S1251N mutation.Secondary Objectives*To assess changes in sweat chloride from baseline (Day 1) as the…

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 randomized, double blind, double-dummy placebo controlled, 3-way cross-over study to determine the test-retest reliability of, and the effect of oral retigabine and riluzole on, peripheral motor nerve excitability measurements in patients with ALS.

Patients with ALS are routinely prescribed riluzole, the only registered drug for the treatment of ALS. This study will evaluate the concentration-effect relationship of riluzole (100 mg) and retigabine (300 mg) on axonal excitability measures. In…

A randomized, open-label, active-controlled, Phase II study of intravenous anetumab ravtansine (BAY 94-9343) or vinorelbine in patients with advanced or metastatic malignant pleural mesothelioma overexpressing mesothelin and progressed on first line platinum/pemetrexed-based chemotherapy

The main purpose of this study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in patients with stage IV, mesothelin overexpressing malignant pleural mesothelioma. Efficacy will be measured…

A Double-blind, Randomised, Placebo-controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients with Vasopressor-dependent Septic Shock

To demonstrate superiority of selepressin plus standard care versus placebo plus standard care in the number of vasopressor- and mechanical ventilator-free days (with penalty for mortality) in patients with vasopressor-dependent septic shock