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Markers for neurocognitive impairment in congenitally CMV infected infants: MARVELYS study

1. To characterize long-term neurologic- and cognitive disorders, audiological and ophthalmological alterations in cCMV-infected children.2. To identify immunological, neurological host factors and virological factors that are predictive of…

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…

Children*s Autoimmunity related to Neuropsychiatric symptoms, Chorea and Epilepsy

(1) To determine the frequency of antibody-mediated encephalopathy in children with seizure-related or (sub)acute onset neuropsychiatric disorders. (2) To identify the target auto-antigens of selected seizure-related and (sub)acute onset…

Antibodies Causing Epilepsy Syndromes

(1) To determine frequency of antibody-mediated encephalopathy in adults with new-onset epilepsy/status epilepticus or chronic epilepsy. (2) To assess outcome of antibody-mediated encephalopathy in adults with epilepsy, and identify markers for good…

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.

Monocyte dysfunction in Multiple Sclerosis (MS)

1). Evaluate the expression of the genes encoding the enzymes that modify histones and DNA during monocyte differentiation in MS.2). Consequences of monocyte dysfunction for migration and cytokine/chemokine production.

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…

Paediatric and Adult Causes of Encephalitis and Meningitis: The PACEM study.

To evaluate the incidence, causes and characteristics of meningitis and/or encephalitis in patients of all ages:1. To determine the causes of meningitis and/or encephalitis in children and adults2. To evaluate the clinical signs and symptoms and CSF…

Cytokines, autoantibodies and astrocytes in the pathology of Aicardi-Goutieres syndrome (AGS)

The objectives of the complete NIMBL study are as follows:Objective 1. Gain insight into the natural history of AGS and RVCL* Create a registry of paediatric and adult AGS and RVCL patients, and develop a network of clinicians caring for these…

A multinational, multicenter, single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial

Primary objective:* To analyze the association between single nucleotide polymorphisms (SNP) markers and treatment response. Treatment response is based on the Expanded Disability Status Scale (EDSS) progression and relapse outcomes over the first 2…

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…

EMR 200136-532: A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®

Primary objective: To assess the efficacy of Vigantol oil versus placebo as add-on therapy in subjects with relapsing-RemittingMultiple sclerosis receiving treatment with Rebif.Secondary objective:To assess changes on clinical parametersto assess…

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…