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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…

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…

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…

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…

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…

German Trial of Acyclovir and Corticosteroids in Herpes-simplex-virus-encephalitis (HSVE); a multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial.

GACHE aims to evaluate the effect on morbidity and mortality of early adjuvantcorticosteroids (dexamethasone) in the treatment of adult patients with HSVE. The major motivation for this trial is the extremely unsatisfactory outcome of patients…

A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis

The objective of the study is to compare the safety and efficacy of masitinib at 4.5 mg/kg/day or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after three month of treatment versus placebo in the treatment of patients with…

Evaluating the effects of intravenous LPS in healthy male volunteers on (neuro)inflammatory biomarkers in CSF and blood

Primary objectives:• To characterize the central inflammatory response to IV LPS by measuring biomarkers in CSF• To characterize the systemic inflammatory response to IV LPS by measuring biomarkers in blood • Characterize CSF/Blood ratios for each…

The effect of rumenic acid rich conjugated linoleic acid supplementation on cognitive functioning

The primary objective is to investigate the effect of 12 weeks of supplementation with 3.5g/day of rumenic acid on episodic memory in older men and women at risk of cognitive impairment. Secondary objectives include working memory, attention,…

A Phase I, single*center, double-blind, randomized, placebo-controlled, single and multiple ascending dose trial to evaluate the safety and pharmacokinetics of PTC857 in healthy volunteers.

Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…

A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.

Primary Objective: To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.Secondary Objectives:1. To compare the efficacy of MEDI-551 versus placebo on the reduction of EDSS…

A single-center randomized, adaptive, investigator/participant blind, single oral ascending dose, placebo-controlled Phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7189752 in healthy male participants.

The purpose of this study is to investigate how safe the new compound RO7189752 is and how well it is tolerated when it is administered as a drink to healthy male volunteers. RO7189752 has not been administered to humans before. It has been…

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…