iConquerMS will Launch the Largest-Ever Study on a new therapy to combat MS fatigue
iConquerMS is partnering with the Department of Veterans Affairs (VA), GAIA AG (a digital therapy company), Charité – Universitatsmedizin Berlin, the University Medical Center Göttingen, and Ordinal Data, Inc., on a four-year, large-scale clinical trial of online programs, or digital therapeutics, for treating fatigue in MS.
This trial is funded by a nearly $4.5 million grant from the Department of Defense Congressionally Directed Medical Research Programs (CDMRP), Multiple Sclerosis Research Program (MSRP).
For many people living with MS, fatigue is a common symptom that limits their ability to engage in regular everyday activities. Affecting about 70 percent of people with MS, it accounts for a substantial portion of the disability and psychosocial burden of this disease. While medication-based treatments have had mixed results in studies and carry risks of side effects, analyses of a number of smaller studies show treatment with non-pharmacological approaches may be effective and safe.
The clinical trial will assess the effectiveness of two online programs and will be conducted with the goal of gaining FDA approval of a novel, non-pharmacological therapy for fatigue in MS. Although they differ, both of these online programs contain potentially useful information about MS and fatigue intended to help people with MS understand and manage this debilitating symptom.
The large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 VA sites in the MS Centers of Excellence is designed to ensure sufficient representation of people living with MS from populations traditionally under-represented in MS clinical trials in order to increase generalizability of the study results.
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