A Longitudinal Study of Neuromyelitis Optica and Transverse Myelitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Benjamin Greenberg, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01623076
First received: June 15, 2012
Last updated: September 5, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Biospecimen Retention:   Samples With DNA

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
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623076

Contacts
Contact: Dina Obrien, BA 214-645-7977 Dina.obrien@utsouthwestern.edu
Contact: Samuel Hughes, BS 214-645-0561 Samuel.Hughes@utsouthwestern.edu

Locations
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Benjamin M Greenberg, MD, MHS         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  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: September 5, 2013
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:
Myelitis
Myelitis, Transverse
Neuritis
Neuromyelitis Optica
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 July 23, 2014