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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…

A randomized, blinded, placebo-controlled, phase II trial of LEE011 in patients with relapsed, refractory, incurable teratoma with recent progression

PrimaryTo assess the efficacy of LEE011 compared to placebo in patients with relapsed/refractory teratoma with recent progressionSecondaryTo assess other measures of efficacy of LEE011 compared with placebo To assess safety and tolerability of…

The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System in Reducing Functional Mitral Regurgitation (FMR) associated with heart failure.

The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a…

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…

Effect of Gelofusine on 111In-DTPA-AHX-Lys40-Exendin 4 uptake in the kidney

Primary Objective: The primary objective is to determine whether the administration of Gelofusine will reduce the kidney uptake of 111In-labeled exendin in humans by enhancing the excretion of 111In-labeled exendin. These highly relevant data can…

A randomized, double-blind, placebo controlled, multiple dose study to evaluate the clinical efficacy, safety, tolerability, dose relation, pharmacokinetics and pharmacodynamics of CJM112 in moderate to severe chronic hidradenitis suppurativa patients

1. To determine the efficacy of CJM112 300 mg in chronic hidradenitis suppurativa (HS) patients, by clinical responder rate at week 16.2. To assess the safety and tolerability of CJM112 in patients with chronic hidradenitis suppurativa (HS)3. To…

A randomized, double-blind, placebo-controlled, cross-over study to assess the effects of fampridine on eye movements and nerve conduction and function in patients with multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO)

Primary objective: - to evaluate the effects of fampridine on eye movements in MS patients with a unilateral or bilateral INO. Secondary objectives:- to determine whether there is an association between MRI signal of the medial longitudinal…

A randomized, placebo-controlled, 2-way crossover, double-blind study to evaluate the efficacy, safety and tolerability of JNJ-42847922 in subjects with insomnia disorder without psychiatric comorbidity.

The purpose of this study is to see if JNJ-42847922 is useful for treating patients with insomnia without any other psychiatric disease. The safety of JNJ-42847922 will also be studied.

Effects of ODM109 on respiratory function in patients with ALS. A
randomised, double blind, placebocontrolled, crossover, 3 period,
multicentre study with openlabel followup extension.

The primary objective of this study will investigate the effect of oral levosimendan on the respiratory function of patients with Amyotrophic Lateral Sclerosis.

A Randomized, Double-Blind, Four Treatment, Four Period, Crossover Study, with Placebo, Tizanidine Immediate-Release and Diphenhydramine to Study Effect of Tizanidine Extended-Release on Simulated Driving Performance, Cognitive, and Psychomotor Functioning

To investigate effect of tizanidine ER 12 mg on simulated driving performance, cognitive and psychomotor functions compared with placebo, tizanidine IR 8 mg (two 4 mg doses given 6.5 hours apart) and active-control in healthy subjects

A phase 2/3, multicenter, randomized, double-blinded, placebo-controlled, repeatdose study to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of olipudase alfa in patients with acid sphingomyelinase deficiency

The primary objective of this study is to evaluate the efficacy of olipudase alfa in adult patients with acid sphingomyelinase deficiency.