Dataset Information

Assessing Repair in Multiple Sclerosis: Outcomes for Phase II Clinical Trials.

ABSTRACT: Multiple Sclerosis (MS) pathology is complex and includes inflammatory processes, neurodegeneration, and demyelination. While multiple drugs have been developed to tackle MS-related inflammation, to date there is scant evidence regarding which therapeutic approach, if any, could be used to reverse demyelination, foster tissue repair, and thus positively impact on chronic disability. Here, we reviewed the current structural and functional markers (magnetic resonance imaging, positron emission tomography, optical coherence tomography, and visual evoked potentials) which could be used in phase II clinical trials of new compounds aimed to foster tissue repair in MS. Magnetic transfer ratio recovery in newly formed lesions currently represents the most widely used biomarker of tissue repair in MS, even if other markers, such as optical coherence tomography and positron emission tomography hold great promise to complement magnetic transfer ratio in tissue repair clinical trials. Future studies are needed to better characterize the different possible biomarkers to study tissue repair in MS, especially regarding their pathological specificity, sensitivity to change, and their relationship with disease activity.

SUBMITTER: Sormani MP

PROVIDER: S-EPMC5722763 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Assessing Repair in Multiple Sclerosis: Outcomes for Phase II Clinical Trials.

Sormani Maria Pia MP Pardini Matteo M

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics 20171001 4

Multiple Sclerosis (MS) pathology is complex and includes inflammatory processes, neurodegeneration, and demyelination. While multiple drugs have been developed to tackle MS-related inflammation, to date there is scant evidence regarding which therapeutic approach, if any, could be used to reverse demyelination, foster tissue repair, and thus positively impact on chronic disability. Here, we reviewed the current structural and functional markers (magnetic resonance imaging, positron emission tom ...[more]

PMID: 28695472

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Project description:: BACKGROUND:: The visual pathways are increasingly recognized as an ideal model to study neurodegeneration in multiple sclerosis (MS). Low-contrast letter acuity (LCLA) and optical coherence tomography (OCT) are validated measures of function and structure in MS. In fact, LCLA was the topic of a recent review by the Multiple Sclerosis Outcome Assessments Consortium (MSOAC) to qualify this visual measure as a primary or secondary clinical trial endpoint with the Food and Drug Administration (FDA) and other regulatory agencies. This review focuses on the use of LCLA and OCT measures as outcomes in clinical trials to date of MS disease-modifying therapies.MethodsA Pubmed search using the specific key words "optical coherence tomography," "low-contrast letter acuity," "multiple sclerosis," and "clinical trials" was performed. An additional search on the clinicaltrials.gov website with the same key words was used to find registered clinical trials of MS therapies that included these visual outcome measures.ResultsAs demonstrated by multiple clinical trials, LCLA and OCT measures are sensitive to treatment effects in MS. LCLA has been used in many clinical trials to date, and findings suggest that 7 letters of LCLA at the 2.5% contrast level are meaningful change. Few clinical trials using the benefits of OCT have been performed, although results of observational studies have solidified the ability of OCT to assess change in retinal structure. Continued accrual of clinical trial and observational data is needed to validate the use of OCT in clinical trials, but preliminary work suggests that an intereye difference in retinal nerve fiber layer thickness of 5-6 μm is a clinically meaningful threshold that identifies an optic nerve lesion in MS.ConclusionsVisual impairment represents a significant component of overall disability in MS. LCLA and OCT enhance the detection of visual pathway injury and can be used as measures of axonal and neuronal integrity. Continued investigation is ongoing to further incorporate these vision-based assessments into clinical trials of MS therapies.

Dataset Information

Assessing Repair in Multiple Sclerosis: Outcomes for Phase II Clinical Trials.

Publications

Assessing Repair in Multiple Sclerosis: Outcomes for Phase II Clinical Trials.

Similar Datasets

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