The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT01623076

Collaborator

(none)

150

Enrollment

Location

132

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Transverse Myelitis Optic Neuritis

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Measure change in standard clinical assessments over time [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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Benjamin Greenberg, Director, Neuromyelitis Optica and Transverse Myelitis Program, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT01623076

Other Study ID Numbers:

STU 022012-084

First Posted:

Jun 19, 2012

Last Update Posted:

May 11, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Benjamin Greenberg, Director, Neuromyelitis Optica and Transverse Myelitis Program, University of Texas Southwestern Medical Center

Neuromyelitis Optica

Neuromyelitis Optica Spectrum Disorder

Transverse Myelitis

Optic Neuritis

Biorepository

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2022