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A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE)

Primary:The primary objective of Study 218MS305 is to determine whether prolonged-release fampridine (10 mg BID) has a clinically meaningful effect on patient-reported walking ability over a 24-week study period.Secondary:The secondary objectives…

Bone Marrow Collection in Healthy Volunteers

The objective of this project is to collect fresh human bone marrow and to process this bone marrow to an intended product in a short time to enable the use of this product in the acute phase of a disease/disorder/lesion of the central nervous…

Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase I- II trial

Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…

Can bilateral functional electrical stimulation (FES) of the calf muscles improve ankle push-off during gait in people with Multiple Sclerosis? A proof of principle study

Aim of this proof of principle study is to develop a reliable and safe application of bilateral FES of the calf muscles to facilitate insufficient push-off in patients with MS and to assess the preliminary effects of FES on net ankle power…

Mechanisms of disability in MS patients with long disease duration

*To examine the (longitudinal) association between long term clinical outcomes in MS and pathology occurring in brain grey matter, spinal cord grey matter and brain lesion load.

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…

*A Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and T-cell tolerizing effect of DC-TAB in healthy volunteers, after single and multiple dosing*

To evaluate the safety and tolerability of DC-TAB following a single dose and following repeated dosing in healthy volunteers. To assess the pharmacokinetics of DC-TAB following a single dose and following repeated dosing in healthy volunteers. To…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE)

The objectives of this study in MS subjects treated with prolonged-release fampridine 10 mg twice daily compared with subjects treated with placebo are: - To assess the effect of prolonged-release fampridine over 24 weeks on the following parameters…

An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long Term Prolonged Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis

Primary: The primary objective of the study is to assess the effect of long term treatment with prolonged release fampridine 10 mg twice daily on the physical component scale (PCS) of the Short Form (36) Health Status Questionnaire (SF 36) as…

Prednisolone addition for patients with recent onset psychotic disorder: the role of immune-modulating strategies in the treatment of psychosis.

We propose to investigate the effect of administering a broad-acting, potent immune suppressive agent early in the course of the disease as this may prevent neuronal damage caused by low-grade inflammatory processes in the brain. It is expected that…

A 3-year, multi-center study to evaluate optical coherencetomography as an outcome measure in patients with multiple sclerosis

Primary objective: To evaluate change in RNFL thickness in RRMS patients followed for up to 36 monthscompared to a group of reference subjects (without neurologic or ophthalmic disease) todetermine whether the technology is sufficiently sensitive to…

A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.

Primary Objective: • The primary objective of the study is to evaluate the efficacy of three doses of atacicept to reduce CNS inflammation in subjects with RMS as assessed by frequent MRI.Secondary Objectives: • Evaluate safety and tolerability of…

A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 150 mg once a week (qw) SC (subcutaneous) administration is safe and effective in reducing the recurrence and symptoms of ankylosing spondylitis over a long period of time (up to 5 years).

A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis

The primary objective of the study is to evaluate the effect of Rebif New Formulation 44 mcg (tiw and ow) versus placebo on the time to conversion to McDonald MS in patients with a first clinical demyelinating event at high risk of converting to MS…

Feasibility and effectiveness of web-based cognitive behavioral therapy for multiple sclerosis patients with co-morbid depression: a pilot study.

The goal of this research project is to evaluate feasibility and outcome of a cognitive behavioural therapy self-help intervention offered through the Internet in multiple sclerosis (MS) patients with a comorbid depressive disorder.

The contribution of the central nervous system to fatigue in patients suffering from MS

In the proposed experiments we intend to investigate both central and peripheral aspects of fatigue in MS-patients using a combination of simultaneously applied techniques; twitch-superimposition, electromyographic (EMG) and force recordings and…

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis

North America, Europe, and rest of worldThe primary objective of this study is to determine whether BG00012, when compared with placebo, is effective in reducing the proportion of relapsing subjects at 2 years.The secondary objectives of this study…

Sirolimus (Rapamune®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes

The primary objective of the trial is to study the efficacccy of sirolimus in paraneoplastisch neurological syndromes associated with anti-Hu antibodies (Hu-PNS)Secondary objectives are to correlate clinical improvement with anti-Hu antibody titers…