MS and NMOSD in African-Americans

Withdrawn

• Conditions: Neuromyelitis Optica; Multiple Sclerosis

• Registration Number: NCT04131673
• Lead Sponsor: Jagannadha R Avasarala

Brief Summary

This is a prospective study that aims to collect and review neuromyelitis optica spectrum disorder (NMOSD) data from African American patients with a known diagnosis of multiple sclerosis (MS). It is an investigational study, prospective in nature. No randomization of patients will be done. Information collected includes: Age, gender, age at diagnosis, MRI data (access to images), clinical presentation, findings on clinical examination, lab (blood and evoked potentials) and LP test results, eye exam findings if any and treatment, if started. Additional details may include other NEUROLOGICAL diseases which are also diagnosed (if any).

Detailed Description

African-Americans with MS are high risk for ambulatory difficulty given aggressive disease phenotype. Disease responsiveness to FDA-approved drugs is also marginal at best.

A positive correlation between the presence of oligoclonal bands (OCBs) and progressive course of MS has been established even when adjusted for ethnicity. It is well documented that the CSF humoral immune response, including a higher IgG index is higher in African-American MS patients. Although MRI lesions, specifically cord and infra-tentorial regions, contribute to disability, the phenotype in African-American populations is also probably linked to HLA-antigen complex. No study has ever collected data as it relates to ethnic background and MS. The University of Kentucky would be the first institution to collect such data.

This is a prospective study that will collect data from patients with the known diagnosis of MS who were later classified as NMOSD from the University of Kentucky's Multiple Sclerosis Clinic. Researchers will use REDCap to store data.

Study Timeline

• Study Start: 2019-07-05
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• between the ages of 18 and 80
• are African-American
• have a diagnosis of MS and later diagnosis of NMOSD
• have been seen at the University of Kentucky's Kentucky Neuroscience Institute

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical data collection and comparison	Through study completion, average duration of four years	Collect patient age, sex, date of birth, and date of diagnosis to examine trends among this population.

Secondary Outcome Measures

Name	Time	Method
Diagnostic tests collection and comparison	Through study completion, average duration of four years	Collect blood tests, CSF studies, mimic conditions, and AQP4 testing will be collected and analyzed for changes over the course of the study and compared to other patients in the study.
MRI analysis	Through study completion, average duration of four years	Analyze MRIs of subjects to see how lesions contribute to this disorder over the course of the study.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States