MS and NMOSD in African-Americans

NCT04131673 | Withdrawn

• 1 other identifier: 51232
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis; Neuromyelitis Optica

Keywords

multiple sclerosis; MS; Neuromyelitis optica spectrum disorder; NMOSD; African Americans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• MRI analysis

  Through study completion, average duration of four years

• Diagnostic tests collection and comparison

  Through study completion, average duration of four years

Study Arms (1)

African Americans with MS

African American patients seen in the University of Kentucky's Multiple Sclerosis Clinic between the ages of 18 and 80 who have been diagnosed with MS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Jagannadha R Avasarala: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Jagannadha Avasarala, MD PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 18, 2019
• Study Start: July 5, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)