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Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain component

Primary objectiveThe primary objective is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol PR (300 mg per day after run in, up titration to 500 mg per day) versus a combination of tapentadol PR (300 mg per…

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

In subjects with T2DM, with inadequate glycemic control, who have a history or high risk of CV disease:Primary Objectives*to assess the effect of canagliflozin plus standard of care relative to placebo plus standard of care on CV risk as measured by…

A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreichâ¤*s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)

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 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohnâ¤*s Disease

Primary: to assess the efficacy of GSK1605786A compared with placebo in maintaining remission. Secondary: Safety, quality of life, healthcare resource utilisation, work productivity.

An outpatient phase 3 efficacy study of Ecopipam (PSYRX 101) in the symptomatic treatment of self-injurious behavior in subjects with Lesch-Nyhan disease.

The primary objective of this study is to assess the efficacy of Ecopipam to reduce self-injurious behaviors (SIB) in adults and children with Lesch-Nyhan Disease (LND) in an outpatient setting. The secondary objectives of this study are to assess…

MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma (MEA115575)

Primary: To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS).Secondary: Safety, tolerability, other efficacy parameters, quality of life.

A randomised, double-blind, placebo-controlled,
multicentre prospective dose-finding Phase II/III study
with atacicept given subcutaneously to subjects having
recently experienced a flare of systemic lupus
erythematosus (SLE)

PRIMAIRYThe primary objective of this trial is to evaluate the efficacy of atacicept compared to placeboin preventing new flares in subjects with SLE.SECONDARYSecondary objectives of the trial are:• To evaluate the safety and tolerability profile of…

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event

The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…

Protocol I1V-MC-EIAN Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes - the ACCELERATE Study

The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary…

Transcranial Direct Current Stmulation in Children with Unilateral Motor Deficits: A New Approach for Pediatric Rehabilitation.

The main objective of this study is to investigate the effect of a single tDCS session in children with mild CP on different motor tasks. The second objective is to identify the optimal site of stimulation. In tDCS research the electrodes can be…

A Multicenter, Phase III, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

The purpose of this study is: * To test the safety of the research study drug MK-3102.* To assess how well the research study drug MK-3102 lowers blood sugar levels (fasting plasma glucose [FPG], post meal glucose [PMG], and glycosylated hemoglobin…

Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy

The primary objective is to test the hypothesis that once daily tadalafil administered orally for 48 weeks lessens the decline in ambulatory ability as measured by the 6MWD compared to placebo in boys with Duchenne muscular dystrophy (DMD). Two…

Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early diabetes

1. To assess whether linagliptin compared with placebo improves arterial stiffness in treatment naïve subjects with type 2 diabetes.2. To assess whether linagliptin compared with placebo improves blood pressure parameters, inflammatory and…

A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of eculizumab in subjects with refractory generalized myasthenia gravis (gMG)

Main Objective:Assess the efficacy of eculizumab as compared with placebo in the treatment of refractory gMG based on the improvement in the MG specific Activities of Daily Living profile (MG-ADL).Secondary Objectives: - Safety and tolerability of…

A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

Primary Objective is to evaluate the long-term safety of sirukumab in subjects with RA who are refractory to DMARDs or anti-TNF* agents.The secondary objectives are to observe the following long-term effects of sirukumab in subjects with RA who are…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the
Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged
12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a
Second Allele With a CFTR Mutation Predicted to Have Residual Function

To evaluate the efficacy of VX-661 in combination with ivacaftor and ivacaftormonotherapy through 8 weeks of treatment in subjects with cystic fibrosis (CF)who are heterozygous for the F508del mutation on the CF transmembraneconductance regulator (…

Varenicline, a partial nicotinic receptor agonist, for the treatment of excessive daytime sleepiness in Parkinson*s disease: a placebo-controlled cross-over study

This study is aimed to determine the efficacy of varenicline in reducing EDS in PD patients.

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallelgroup, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2- amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy

To evaluate the efficacy of JZP-110 administered once daily for up to 12 weeks in doses of 75, 150, and 300 mg compared to placebo in the treatment of excessive sleepiness in adult subjects with narcolepsy.

A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk. The CAROLINA Trial.

CAROLINA studyThe aim of the present study is to investigate the long*term impact on CV morbidity and mortality and relevant efficacy parameters (HbA1c, fasting plasma glucose, treatment sustainability) of treatment with linagliptin in a relevant…