You know that I’m not that bothered with these “this is my new clinial trial” papers but it let’s you know what is happenening and it may help the trials to recruit people. This is a remyelination study so I thought that you may be interested as its not all about relapses. However, unfortunately you will have to wait for the results
Nylander A, Anderson A, Rowles W, Hsu S, Lazar AA, Mayoral SR, Pease-Raissi SE, Green A, Bove R.Contemp Clin Trials. 2023 Sep 20:107333. doi: 10.1016/j.cct.2023.107333.
Introduction: Multiple sclerosis (MS) is a major cause of disability in young and middle-aged people, and myelin repair therapies are needed to slow or potentially reverse this damage. Bazedoxifene (BZA) is a selective oestrogen receptor modulator identified in ….unbiased screen for its remyelinating potential, and its remyelinating effects were demonstrated in pre-clinical models.
Methods: This is a single-center, double blind, randomized, controlled, delayed-start Phase 2 clinical trial (NCT04002934) investigating the remyelinating effects of BZA relative to placebo. Female patients with relapsing-remitting MS, aged 45-60 years (or > 40 if post-menopausal), and ambulatory status (EDSS 0-6 inclusive), will be recruited into a clinical trial with 2 arms of identical design, except that the “Chronic Optic Neuropathy” arm requires additional inclusion criteria of electrophysiological evidence of prior visual pathway demyelination. Clinical, electrophysiological, and imaging evaluations will occur at baseline, 3 months, and 6 months. The primary outcome is change in Myelin Water Fraction (MWF) on MRI within the corpus callosum (The nerve highay betweenthe left and right sides of the brain). Secondary outcomes are: visual evoked potential (VEP) P100 latency, novel digital measures of cognition and activity, and patient reported outcomes. Tertiary outcomes are: safety and tolerability.
Discussion: BZA has strong preclinical effects on myelin repair, and in the general population demonstrated benefits in treating post-menopausal osteoporosis. Together, these findings support the rationale for an RCT testing BZA in women with MS, evaluating established neuroimaging and neurovisual measures of myelin repair. Additionally, validating novel digital tools could increase sensitivity to change and inform the duration and design of future clinical trials.
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