MS and NMOSD in African-Americans

Multiple Sclerosis Clinical Trial

Official title:

MS and NMOSD in African-Americans: a Prospective Data Collection Protocol Using REDCap

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04131673
• Other study ID #: 51232
• Status: Withdrawn
• Start date: July 5, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuromyelitis Optica
• Sclerosis

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Jagannadha R Avasarala

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical data collection and comparison	Collect patient age, sex, date of birth, and date of diagnosis to examine trends among this population.	Through study completion, average duration of four years
Secondary	MRI analysis	Analyze MRIs of subjects to see how lesions contribute to this disorder over the course of the study.	Through study completion, average duration of four years
Secondary	Diagnostic tests collection and comparison	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.	Through study completion, average duration of four years