The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders

Optic Neuritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01623076
• Other study ID #: STU 022012-084
• Status: Recruiting
• Start date: June 2012
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Jan Cameron-Watts, RN
• Phone: 214-645-0555
• Email: jan.cameronwatts[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelitis
• Myelitis, Transverse
• Neuritis
• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder
• Optic Neuritis
• Transverse Myelitis

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Guthy Jackson Charitable Foundation for NMO
•   Transverse Myelitis Association