Neuromyelitis OpticaNCT01623076
The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders
An observational study of Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients previously diagnosed with Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis and Optic Neuritis will be recruited to take part in a longitudinal study of their disease.
Who may be able to join
- 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
Who cannot join
- Unable to maintain scheduled visits
- Patient has known HIV or hepatitis C infection
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Collaboration on Neuroimmunology: Question, Understand, Educate, Restore - The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders
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.
Read the 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.
- Conditions
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis, Optic Neuritis
- Keywords
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis, Optic Neuritis, Biorepository
- Medical subject headings
- Neuromyelitis Optica, Myelitis, Transverse, Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every study visit
Secondary outcomes (3)
Measure change in cognition measures over time
Cognition measures include the SDMT, JLO, and PASAT
Measured: Every study visit
Measure change in self-reported quality of life surveys
Surveys include MSNQ, MSQOL-54, QIDS, BDI-II, FSS, ESS, MFIS, BPI, and Neuro-QoL
Measured: Every study visit
B cell population changes
Measure B cell subtypes and changes over time
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis OpticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Greenberg, University of Texas Southwestern Medical Center
- Investigators
- Benjamin M Greenberg, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623076
- Sponsor's protocol ID
- STU 022012-084
- Status last verified
- Jan 2026
- First submitted
- 15 Jun 2012
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified data can be shared with IRB approved researchers upon request and approval from PI
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaboration on Neuroimmunology: Question, Understand, Educate, Restore - The Longitudinal CONQUER Study of Rare Neuroimmunologic Disorders
- ClinicalTrials.gov ID
- NCT01623076
- Acronym / sponsor ID
- STU 022012-084
- Conditions
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis, Optic Neuritis
- Keywords
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis, Optic Neuritis, Biorepository
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients previously diagnosed with Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Transverse Myelitis and Optic Neuritis will be recruited to take part in a longitudinal study of their disease.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to maintain scheduled visits
- Patient has known HIV or hepatitis C infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure change in standard clinical assessments over time
Time frame: 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
3 secondary outcomes
Measure change in cognition measures over time
Time frame: Every study visit
Measure change in self-reported quality of life surveys
Time frame: Every study visit
B cell population changes
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. Deidentified data can be shared with IRB approved researchers upon request and approval from PI
Related trials for Neuromyelitis Optica
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Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder
Neuromyelitis Optica Spectrum Disorder
RecruitingPhase 1/2
Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases
Chronic Inflammatory Demyelinating Polyradiculoneuropathy, NMO Spectrum Disorder
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Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Greenberg, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure change in standard clinical assessments over time (time frame: Every study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.