Optic Neuritis Clinical Trial
Official title:
Collaboration on Neuroimmunology: Question, Understand, Educate, Restore - The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders
NCT number | NCT01623076 |
Other study ID # | STU 022012-084 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | June 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
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 |
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