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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…

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…

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…

The effect of interferon beta-1a treatment on functional adaptation in Multiple Sclerosis (MS)

Primary: Does immunomodulation brought about by interferon beta-1a (Rebif) enhance or prolong functional reorganization in subjects with RRMS?Secondary: Does interferon beta-1a (Rebif) also affects functional connectivity as measured by resting-…

A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β-1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis

The primary objective of this study is to evaluate the efficacy (clinical and MRI) of switching tonatalizumab compared to receiving interferon β1-a or glatiramer acetate.

A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy

The objectives of this study are to compare the safety and efficacy of 2 annual cycles of intravenous (IV) alemtuzumab to 3-times weekly subcutaneous (SC) interferon beta 1a (Rebif*) in patients with active relapsing-remitting multiple sclerosis (…

Efficacy of client-centred occupational therapy in patients with multiple sclerosis: a cluster-randomized trial

The main research question of this study is:Is client-centred occupational therapy according to the Occupational Performance Process Model more effective than usual-care occuaptional therapy in patients with multiple sclerosis?

Fatigue after mild traumatic brain injury

How important is fatigue in patients with MTBI? What are the mechanisms underlying the decline in force during a fatiguing task? Which changes in brain activation take place during the fatiguing task?

First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG (PN-1007) in anti-MAG neuropathy patients.

Primary objectiveTo assess the safety and tolerability after single and multiple intravenous administrations of PPSGG in patients suffering from anti-MAG neuropathy.Secondary objectives- To evaluate the PK of PPSGG after single and multiple…

Randomized Autologous heMatopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis

This study has been transitioned to CTIS with ID 2024-510630-40-00 check the CTIS register for the current data. The objective of this prospective, randomized study is to investigate the efficacy and safety of HSCT compared to the comparator group (…

Effects of dimethyl fumarate (Tecfidera) on white matter integrity and functional brain adaptation and cognition in Multiple Sclerosis

The primary objective of the study is to investigate changes in white matter structural integrity in patients with relapsing remitting multiple sclerosis (MS) after treatment with dimethyl fumarate and its relation to physical and cognitive…

Blended versus face-to-face Cognitive Behavioural Therapy in treating severe fatigue in patients with MS - an observer-blinded randomized clinical trial testing non-inferiority at post-treatment and long-term effectiveness.

1. To investigate the non-inferiority of blended CBT compared to proven effective face-to-face CBT according to the TREFAMS-CBT treatment protocol in severely fatigued patients with MS, using a non-inferiority margin of 5.3 points on the Checklist…

Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis: a randomized controlled trial

With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity (clinically and radiologically) compared to the standard (fixed 24 week interval) treatment.

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS

The goal of the fenebrutinib development program in MS is to evaluate the benefits and risks of fenebrutinib treatment across the spectrum of patients with MS. Based on the existing toxicology, pharmacology, and clinical experience with fenebrutinib…

DE-escalating ocRelizumAb In cLinical and radiological stable MS

To describe the efficacy and safety of a maintenance versus induction anti-CD20 treatment strategy in pwMS.

Efficacy of add-on high-dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial.

To assess the efficacy of add-on high-dose simvastatin on markers for disease progression in MS patients treated with natalizumab or ocrelizumab for at least six months.

A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

This study will evaluate the efficacy, safety, and pharmacokinetics of a higher dose of ocrelizumab compared with the approved dose of ocrelizumab in patients with relapsing forms of multiple sclerosis.

Assessing fatigue, disease activity and progression through smartphone surveillance in multiple sclerosis

to develop and explore measuring methods using conventional smartphones to quantify fatigue, disease activity, and short term and long progression in a day-to-day setting in patients with MS. Key research questions: - Are the NeuroKeys and MS Sherpa…

The effect of cognitive rehabilitation therapy and mindfulness based cognitive therapy on cognitive functioning in multiple sclerosis.

The main aim of the current study is to investigate whether two promising therapies, namely cognitive rehabilitation therapy (CRT) and mindfulness based cognitive therapy (MBCT), may improve cognitive functioning of patients with MS. Additionally,…

Need for speed: a pilot study on feasibility of cognitive rehabilitation for patients with progressive multiple sclerosis (MS)

The aim of this pilot study is to investigate the feasibility and to gain preliminary information on the effectiveness of a cognitive rehabilitation program in patients with (severe) progressive MS, i.e. a speed of processing training (SPT).…