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A Multicenter, Open-Label Study to Evaluate Fatigue in Subjects With Relapsing-Remitting Multiple Sclerosis During Treatment With Tecfidera® (Dimethyl Fumarate) Gastro-Resistant Hard Capsules (TECNERGY)

Primary:The primary objective of this study is to determine whether DMF taken over 12 months is effective in reducing MS-related fatigue, as measured by mean changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC), in subjects with…

The effects and costs of a multidisciplinary symptomatic treatment strategy on quality of life of people severely affected by MS

The aim of the proposed study is to obtain insight into the needs, functioning and quality of life and changes in these outcomes of people with severe MS who are treated in NU and to identify the experiences, facilitators and barriers using the…

A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis

To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in…

Towards personalized dosing of natalizumab in multiple sclerosis

Our main objective is to prove that extending dose intervals guided by serum concentrations of natalizumab, will not result in radiological or clinical disease activity.

A first-in-human, single-centre, placebo-controlled, randomized, double-blind study in healthy subjects to evaluate safety, tolerability, pharmacokinetics and food effect after oral single and multiple ascending dosing of KAND567

The primary objective is to determine the safety and tolerability of KAND567 following oral single ascending dose (SAD) and multiple ascending doses (MAD) administration in healthy young and elderly subjects.

Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003.

Primary objective: To evaluate the long-term safety of IgPro20.Secondary objectives: * To evaluate the long-term safety of IgPro20 by dose. * To evaluate the efficacy of IgPro20.Exploratory objectives:* To evaluate health-related quality of life (…

Effects of fingolimod on functional brain adaptation and clinical measures in multiple sclerosis

The main objective of the proposed study is to investigate whether the disproportionally strong clinical effects of fingolimod in RRMS can be explained by enhanced functional brain adaptation and whether enhanced functional adaptation is sustained…

Mindfulness Based Cognitive Therapy for subjective fatigue in patients with multiple sclerosis: a prospective cohort study on effectiveness and feasibility.

The purpose of the present study is the evaluation of the effectiveness of MBCT in MS patients. Based on previous research we hypothesize that after the MBCT intervention period, MS patients will have significantly less symptoms of fatigue than…

Randomized, first in human, double-blind, placebo- and active comparator- controlled 3-way crossover study in healthy male subjects (part 1), and a subsequent parallel open label study in healthy male and female subjects and MS patients (part 2), to assess the safety, pharmacokinetics and pharmacodynamics of 2B3-201.

Primairy objective:• To determine the safety, tolerability and pharmacokinetics of 2B3-201, and in comparison to free methylprednisolone hemisuccinate and placebo;Secundairy objective:• To determine the pharmacodynamic effects of 2B3-201 on CNS…

Controlled Study on the Effectiveness of a Dutch Can Do Training (CDT) in People with Relapsing Remitting Multiple Sclerosis

To investigate the effect of a Dutch Can Do Training (CDT) on self-efficacy in people with Relapsing Remitting Multiple Sclerosis.

A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months* administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) (OMS112831)

Primary: To determine whether ofatumumab 3, 30 or 60 milligrams (mg) given subcutaneously (SQ), reduces the cumulative number of new T1 GdE brain lesions over a period of 12 weeks, as compared with placebo.Secondary: Cumulative number of new T1 GdE…

Randomized, multicenter, double-blind, placebo-controlled, parallel group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

The primary objective of the study is to determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placeboSecondary objectives:* To investigate the efficacy of…

A Dose-Frequency Blinded, Multicenter, Extension Study to
Determine the Long-Term Safety and Efficacy of PEGylated
Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple
Sclerosis

Primary: To evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.Secondary: To describe long-term MS outcomes in subjects originally treated in Study 105MS301 who…

Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis (CFTY720D2306E1)

Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.

Treatment of Fatigue in Multiple Sclerosis: Aerobic Training, Cognitive Behavioural Therapy, Energy Conservation Management

To determine whether rehabilitation treatment strategies effectively reduce fatigue and improve participation in MS patients with fatigue, and how they exert their effects.Research questionsQ1) Does AT result in reduced fatigue and improved…

A double-blind, randomized, mulicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…

The effect of natalizumab treatment on functional adaptation in multiple sclerosis (MS)

The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…

Exploratory open label study to investigate the effect of teriflunomide on immune cell subsets in the blood of patients with relapsing forms of multiple sclerosis

Primary:- To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary:- To assess…

Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada.

The objective of this study is to assess the distribution of infusion associated reactions (IARs) by severity grade when Lemtrada is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion…

Immune regulation by dimethylfumarate (DMF) in patients with relapsing Remitting Multiple Sclerosis.

Primary objective: * Increases treatment with DMF the ability of Tregs to inhibit in relapsing-remitting MS patients? Proliferation of conventional T cells * Provides treatment with DMF to an increase in the number of nTreg (Foxp3 expression) or…