The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Recruiting

• Conditions: Transverse Myelitis; Neuromyelitis Optica Spectrum Disorder; Neuromyelitis Optica; Optic Neuritis

• Registration Number: NCT01623076
• Lead Sponsor: University of Texas Southwestern Medical Center

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States