A Longitudinal Study of Neuromyelitis Optica and Transverse Myelitis
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Purpose
This study seeks to determine the biologic causes of inflammation in patients with Neuromyelitis Optica (NMO) 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 |
|---|
|
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Transverse Myelitis Optic Neuritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Longitudinal Study of Patients Diagnosed With or at Increased Risk for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder |
Patients will donate serum, plasma, DNA, RNA and white blood cells.
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2012 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Neuromyelitis Optica |
| Neuromyelitis Optica Spectrum Disorder |
|
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 |
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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| Contact: Morgan C McCreary, BS | 214-645-0561 | Morgan.McCreary@utsouthwestern.edu |
| Contact: Samuel Hughes, BS | 214-645-7977 | Samuel.Hughes@utsouthwestern.edu |
| United States, Texas | |
| The University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Principal Investigator: Benjamin M Greenberg, MD, MHS | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Benjamin Greenberg, Director, Neuromyelitis Optica and Transverse Myelitis Program, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT01623076 History of Changes |
| Other Study ID Numbers: | STU-022012-084 |
| Study First Received: | June 15, 2012 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Transverse Myelitis Optic Neuritis Biorepository |
Additional relevant MeSH terms:
|
Neuromyelitis Optica Myelitis Myelitis, Transverse Neuritis Optic Neuritis Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site |
Neoplasms Paraneoplastic Syndromes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Demyelinating Diseases Neurodegenerative Diseases Autoimmune Diseases Immune System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Multiple Sclerosis Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013