Largest-Ever Study of New MS Fatigue Therapy Launched by Accelerated Cure Project & iConquerMS

WALTHAM, Mass., May 29, 2024 -- The iConquerMS™ People-Powered Research Network (PPRN), an initiative of the Accelerated Cure Project (ACP), has launched a significant clinical trial in collaboration with several partners, including the Department of Veterans Affairs (VA), digital therapy firm GAIA AG, Charité – Universitätsmedizin Berlin, the University Medical Center Göttingen, and Ordinal Data, Inc. This four-year trial, which is funded by a nearly $4.5 million grant from the Department of Defense's Multiple Sclerosis Research Program, aims to evaluate the effectiveness of online programs, known as digital therapeutics, in managing fatigue in individuals with multiple sclerosis (MS).

Fatigue is a prevalent symptom among those living with MS, affecting roughly 70% of patients and significantly impacting their daily activities and quality of life. Traditional medication-based treatments have shown mixed results and often come with side effects, whereas non-pharmacological treatments have demonstrated potential benefits in smaller studies.

The upcoming clinical trial intends to test two distinct online programs, each designed to help patients better understand and manage their fatigue, with the ultimate goal of gaining FDA approval for a new non-pharmacological therapy for MS-related fatigue. The trial, which will enroll 2,000 participants, is structured to enhance the representation of traditionally under-represented populations within MS clinical studies, thereby broadening the applicability of the findings.

Laura Kolaczkowski, Lead Patient Representative for iConquerMS, emphasized the significance of the study, noting the community's enthusiasm for a non-pharmacological treatment that could be universally accessible. The study's large and inclusive design aims to provide conclusive evidence on the effectiveness of these online programs.

GAIA, alongside Charité and the University Medical Center Göttingen, previously conducted a trial with 275 patients using a digital therapeutic program for fatigue, showing significant reductions in fatigue levels without safety concerns. This program, already approved by German authorities and covered by health insurance, will be one of the programs tested in the new US trial.

The US trial will follow a 3-arm, randomized controlled format, with participants divided into three groups: one using each of the two online programs along with their usual MS treatment, and a control group receiving only their standard treatment. The trial's main phase will last six months, followed by a final evaluation at 12 months. Participants in the control group will have the option to use one of the online programs in the latter half of the trial.

Robert McBurney of ACP, a co-lead investigator, highlighted the importance of finding scalable, non-pharmacological treatments for MS fatigue. Such therapies could be particularly beneficial for patients in rural areas or those facing barriers to more traditional medical treatments.

iConquerMS is a network driven by individuals affected by MS, including patients, caregivers, researchers, and advocates, working collectively to advance the understanding and treatment of the disease. This trial is part of their broader efforts to gather valuable data and develop treatments that improve the lives of those with MS.

The study's partners include prestigious institutions and organizations such as Charité – Universitätsmedizin Berlin, the University Medical Center Göttingen, and Ordinal Data, Inc., each bringing their expertise to the project.

The Multiple Sclerosis Research Program (MSRP), established by Congress in 2009, has been pivotal in supporting innovative research to address key challenges in MS. The program has received substantial funding over the years, including $20 million in 2024, to advance impactful research initiatives.

This project is endorsed by the Department of Defense and reflects a broader commitment to advancing healthcare solutions for Service Members, Veterans, and the general public through high-impact research.

The clinical trial is expected to begin recruiting participants in the summer of 2024 through the iConquerMS network and in the fall of 2024 at VA sites.

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