The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Brief Title

The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Official Title

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

Brief Summary

      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.
    

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


Primary Outcome

Measure change in standard clinical assessments over time

Secondary Outcome

 Measure change in cognition measures over time

Condition

Neuromyelitis Optica


Study Arms / Comparison Groups

 Neuromyelitis Optica Spectrum Disorder
Description:  Patients diagnosed with NMOSD based on revised diagnostic criteria. Seronegative, anti-AQP4 seropositive and ant-MOG seropositive patients will be included

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

150

Start Date

June 2012

Completion Date

June 2023

Primary Completion Date

June 2023

Eligibility Criteria

        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
      

Gender

All

Ages

6 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Benjamin M Greenberg, MD, 214-645-0555, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01623076

Organization ID

STU 022012-084


Responsible Party

Principal Investigator

Study Sponsor

University of Texas Southwestern Medical Center


Study Sponsor

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


Verification Date

May 2021