The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	6 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01623076
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Texas Southwestern Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Benjamin M Greenberg, MD
Principal Investigator Affiliation	University of Texas Southwestern Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis, Optic Neuritis
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dallas, Texas

Status

Recruiting

Address

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Benjamin M Greenberg, MD, MHS

[email protected]

214-645-0555

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