Multiple SclerosisNCT04131673
MS and NMOSD in African-Americans
An observational study of Multiple Sclerosis and Neuromyelitis Optica, run by Jagannadha R Avasarala at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MS and NMOSD in African-Americans: a Prospective Data Collection Protocol Using REDCap
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).
Read the 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.
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica
- Keywords
- multiple sclerosis, MS, Neuromyelitis optica spectrum disorder, NMOSD, African Americans
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical data collection and comparison
Collect patient age, sex, date of birth, and date of diagnosis to examine trends among this population.
Measured: Through study completion, average duration of four years
Secondary outcomes (2)
MRI analysis
Analyze MRIs of subjects to see how lesions contribute to this disorder over the course of the study.
Measured: Through study completion, average duration of four years
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.
Measured: Through study completion, average duration of four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start5 Jul 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: IRB closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagannadha R Avasarala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jagannadha R Avasarala, University of Kentucky
- Investigators
- Jagannadha Avasarala, MD PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131673
- Sponsor's protocol ID
- 51232
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MS and NMOSD in African-Americans: a Prospective Data Collection Protocol Using REDCap
- ClinicalTrials.gov ID
- NCT04131673
- Acronym / sponsor ID
- 51232
- Conditions
- Multiple Sclerosis, Neuromyelitis Optica
- Keywords
- multiple sclerosis, MS, Neuromyelitis optica spectrum disorder, NMOSD, African Americans
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: IRB closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jagannadha R AvasaralaUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical data collection and comparison
Time frame: 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.
2 secondary outcomes
MRI analysis
Time frame: Through study completion, average duration of four years
Diagnostic tests collection and comparison
Time frame: Through study completion, average duration of four years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jagannadha Avasarala, MD PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Neuromyelitis Optica, run by Jagannadha R Avasarala at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical data collection and comparison (time frame: Through study completion, average duration of four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.