MS and NMOSD in African-Americans | NCT04131673

Studies
MS and NMOSD in African-Americans

NCT04131673

Sponsor

Jagannadha R Avasarala

Status

Withdrawn

Last Update Posted

Nov 14, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Multiple Sclerosis
Neuromyelitis Optica

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IRB closed

Expanded Access Info

Start Date

Jul 5, 2019Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Oct 14, 2019

First Submission Date that Met QC Criteria

Oct 17, 2019

First Posted Date

Oct 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2022

Last Update Posted Date

Nov 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jagannadha R Avasarala, Professor of Neurology, University of KentuckySponsor-Investigator

Lead Sponsor

Jagannadha R AvasaralaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Diagnostic tests collection and comparison

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jagannadha Avasarala, MD PhD	University of Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40536	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D009471	Neuromyelitis Optica

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

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Browse Branches

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