Clinical trial NCT04131673: MS and NMOSD in African-Americans
Official title: MS and NMOSD in African-Americans: a Prospective Data Collection Protocol Using REDCap
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Sclerosis
Neuromyelitis Optica
Keywords: multiple sclerosis
MS
Neuromyelitis optica spectrum disorder
NMOSD
African Americans
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American patients who have been diagnosed with MS and later diagnosed as having NMOSD. They will be patients that have been seen in the Kentucky Neuroscience Institute (KNI). The age range will be 18-80.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical data collection and comparison
timeFrame: Through study completion, average duration of four years
Secondary outcomes:
measure: MRI analysis
timeFrame: Through study completion, average duration of four years
measure: Diagnostic tests collection and comparison
timeFrame: Through study completion, average duration of four years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jagannadha Avasarala, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: