The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

September 2, 2023 updated by: Benjamin Greenberg, University of Texas Southwestern Medical Center

Collaboration on Neuroimmunology: Question, Understand, Educate, Restore - The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

This study seeks to determine the biologic causes of inflammation in patients with Transverse Myelitis (TM) Neuromyelitis Optica Spectrum Disorder (NMOSD) and related conditions. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study seeks to determine the biologic causes of inflammation in patients with Neuromyelitis Optica (NMO), Transverse Myelitis (TM), optic neuritis (ON), related conditions and healthy controls. While patients will be treated according to decisions with their treating physician, this study will collect data and samples from patients prospectively to gain a better understanding of the disease. We are seeking to understand why some patients respond to medications, while others do not. We also seek to understand what happens biologically, preceding relapses. Gathering these data and samples will allow researchers to identify new ways of diagnosing and treating these diseases. Data and samples will be shared with researchers around the world to support collaborative efforts to treat these conditions.

Patients will agree to share medical records, complete questionnaires and donate samples on a timed basis.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • The University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Benjamin M Greenberg, MD, MHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients previously diagnosed with Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis and Optic Neuritis will be recruited to take part in a longitudinal study of their disease.

Description

Inclusion Criteria:

  • Age 6 years or greater
  • Male or Female
  • Patient or Parent (in the case of a minor) able to give informed consent
  • For patients 10 to 17, patient able to assent
  • Patient diagnosed with NMO, NMOSD, TM or ON

Exclusion Criteria:

  • Unable to maintain scheduled visits
  • Patient has known HIV or hepatitis C infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Neuromyelitis Optica Spectrum Disorder
Patients diagnosed with NMOSD based on revised diagnostic criteria. Seronegative, anti-AQP4 seropositive and ant-MOG seropositive patients will be included
Transverse Myelitis and Optic Neuritis
Patients who have had one demyelinating event, not diagnosed with multiple sclerosis and whom are considered at risk for NMO or NMOSD.
Healthy Controls
patients without a history of CNS inflammation
Neuromyelitis Optica
patients diagnosed with NMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change in standard clinical assessments over time
Time Frame: Every study visit
Standard clinical assessments include: relapse information, level of disability based on EDSS score, high and low contract visual acuity, ambulation index, optical coherence tomography, and MRI, and neurologic/physical exam
Every study visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change in cognition measures over time
Time Frame: Every study visit
Cognition measures include the SDMT, JLO, and PASAT
Every study visit
Measure change in self-reported quality of life surveys
Time Frame: Every study visit
Surveys include MSNQ, MSQOL-54, QIDS, BDI-II, FSS, ESS, MFIS, BPI, and Neuro-QoL
Every study visit
B cell population changes
Time Frame: Up to 5 years
Measure B cell subtypes and changes over time
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Benjamin M Greenberg, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (Estimated)

June 19, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 022012-084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data can be shared with IRB approved researchers upon request and approval from PI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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