This is a Global, Multicentre Phase III, Randomised, Double-Blind Clinical Trial. The study will include over 150 adults and adolescents (12-18 years of age) with MOGAD from around the world. Participants will be randomly assigned between treatment arms. In Australia 8 sites will participate in the study, 4 in NSW, 3 in Victoria and 1 […]
The Wellbeing Neuro Course: A Randomised Controlled Trial of an Online Treatment Program for Adults with Multiple Sclerosis
Mental health (e.g., anxiety, depression) and functional difficulties (e.g., cognitive problems) are highly comorbid in people with Multiple Sclerosis (MS). However, access to effective psychological treatments are limited. People with MS face many barriers (e.g., costs, limited trained clinicians, mobility issues) accessing effective psychological care. The Wellbeing Neuro Course offers an innovative solution to these […]
Reducing the frequency of Autoimmune adverse events in the treatment of Multiple sclerosis with alemtuzumab using B-celL dEpletion (RAMBLE): a phase II, randomised, placebo-controlled clinical trial
To reduce the occurrence of autoimmune adverse events from the treatment of multiple sclerosis (MS) with alemtuzumab through the subsequent targeted use of rituximab. The hypothesis to be tested is that rituximab therapy following alemtuzumab treatment for MS will reduce the frequency of autoimmune adverse events. If this strategy proves to be safe and is […]
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab (ARTIOS)
This is a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.
Individuals with MS and migraine can face difficulties with thinking skills (e.g. concentration and memory), mood, fatigue, work and social activities. However, to date, there has been no CBT program developed that is specifically tailored to these difficulties for individuals with MS and migraine. The project aims to assess how feasible and acceptable such a […]
Effects of a probiotic intervention on cognitive symptoms and gut-brain biomarkers in multiple sclerosis (MS); a pilot study.
This study will be a pilot examination of the effectiveness of a multi-strain probiotic intervention to improve cognitive symptoms (primary outcome variables), and cognition-related fatigue, everyday functioning and health-related quality of life (secondary outcome variables) in people living with Relapsing Remitting and Secondary Progressive MS. The study will also examine the potentially important relationship between […]
A Phase 3, Randomized, Double-Blind, Efficacy and Safety Study Comparing SAR442168 To Placebo In Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
SAR442168 is being developed for the indication of treatment of patients with MS. This study is designed to collect evidence of efficacy and safety of the drug. The goal of this Phase 3 clinical trial is to demonstrate the efficacy and safety of SAR442168 compared to placebo in participants with primary progressive multiple sclerosis (PPMS). […]
This study aims to observe the effectiveness of a practical cooling strategy (cold water spray bottle skin cooling) in reducing heat-related fatigue in hot conditions for people with MS. Participants will complete 5 sessions in total: • 3 practice sessions (1.5hr each): two cycling, handgrip & balance sessions in room temperature conditions, and one in […]
To investigate the acute effect of the UnderCool 2.0 cooling vest during high-intensity exercise in a heat sensitive MS population on; i) body temperatures and sweating, ii) feelings of exertion and hotness, iii) MS symptoms that are aggravated by heat, and iv) Concealability, comfort and functionality. With a controlled, cross-over design, 20 participants diagnosed with […]
An online lifestyle modification course for people with multiple sclerosis: a randomised controlled trial of course effectiveness
Lifestyle factors are known to affect the progression of multiple sclerosis (MS). The Multiple Sclerosis Online Course (MSOC) has been developed to deliver a widely accessible and user-friendly educational tool regarding modification of lifestyle related risk factors for people with MS. The intervention consists of arms: 1. an MS Online intervention course based delivering evidence-based […]