Multiple Sclerosis, Chronic Progressive

The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577. This study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of chronic demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis. In addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.

The Clinnova-Multiple Sclerosis (MS) study is part of the Clinnova program (NCT06526364; NCT06235684 and NCT05733702), which seeks to advance precision medicine and the digitalization of healthcare through high-quality, interoperable health data. This program focuses on people with multiple sclerosis (MS) and aims to identify objective surrogate markers derived from clinical, epidemiological, imaging, and omics data that can predict disease activity, such as progression or relapses. By combining data science and artificial intelligence, the project seeks to improve patient stratification, support personalized therapeutic decisions, and provide insights into the mechanisms underlying treatment response and disease progression. Although many therapies are available for MS, it remains challenging to determine the most appropriate strategy for each patient and to prevent long-term disability. Current treatments mainly target relapses and inflammation, with limited effects on chronic progression. Clinnova-MS will collect and analyze real-world and research data to better understand variability in disease activity and treatment outcomes, enabling more precise, evidence-based care within the standard of care. This study represents the first step toward the broader Clinnova objective: developing sustainable, personalized, and preventive healthcare for people living with MS.

The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).