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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01396343
Other study ID # 5R01NS071463
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2011
Est. completion date April 2018

Study information

Verified date October 2018
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to better understand multiple sclerosis (MS) in children and adolescents, to learn if it differs from adult MS and to investigate if genes or environmental exposures or a combination of both put children and adolescents at risk for getting MS.


Description:

The overall goal of this project is to determine whether well-established environmental and genetic risk factors for adult onset MS play an important role in susceptibility to pediatric-onset MS. Our study design is based on the hypothesis that genetic influences, specifically variation at HLA-DRB1 and other confirmed non-MHC MS loci, as well as environmental exposures including EBV infection and tobacco smoke, contribute to disease risk. In addition, we will also examine the relationship between serum levels of 25(OH) vitamin D3 and prior vitamin D status, and risk for pediatric onset MS. Finally, we will investigate whether specific G x E, and other multivariable relationships influencing risk exist for pediatric-onset MS. There are 16 collaborating sites other than UCSF that will enroll cases and controls for this study.


Recruitment information / eligibility

Status Completed
Enrollment 1276
Est. completion date April 2018
Est. primary completion date April 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 21 Years
Eligibility Children are eligible for this study as cases if:

- They have MS or clinically isolated syndrome (CIS):

- MS: As defined by the 2010 McDonald criteria for diagnosis of MS (Polman 2010),

- CIS: A first demyelinating event indicating high risk for MS (i.e., one clinical event involving the spinal cord, the optic nerve, the brainstem or cerebellum, or occasionally the hemispheres) and at least 2 silent T2 bright areas on a brain or spinal cord MRI (at least one must be in the brain); AND

- They are three years of age or older; AND

- Disease onset occurred before 18 years of age.

Patients are not eligible for study participation if:

- Disease onset occurred more than 4 years prior to the opportunity to enroll; OR

- They have had an organ transplant; OR

- They are known to have neuromyelitis optica (NMO).

Children are not eligible to participate as pediatric controls if:

- They are two years of age or younger; OR

- They are 22 years of age or older; OR

- They are known to have MS or another demyelinating disease (for example, neuromyelitis optica or acute disseminated encephalomyelitis); OR

- They have a biological family member who has been enrolled as a control; OR

- They have an immediate, biological family member (parent/sibling) who has been diagnosed with MS; OR

- They have an autoimmune disorder (except asthma or eczema); OR

- They have had an organ transplant; OR

- They have a chronic neurological condition with major disability (this does not include, for example, migraine, controlled seizures, and mild learning disabilities such as ADD or ADHD).

Study Design


Locations

Country Name City State
United States Children's Hospital Colorado, University of Colorado School of Medicine Aurora Colorado
United States Center for pediatric-onset demyelinating diseases at the Children's Hospital of Alabama, Birmingham Birmingham Alabama
United States Partners Pediatric MS Center at the Massachusetts General Hospital for Children Boston Massachusetts
United States Pediatric MS Clinic, Children's Hospital Boston Boston Massachusetts
United States Pediatric MS Center of the Jacobs Neurological Institute, University of Buffalo Buffalo New York
United States Pediatric MS Clinic, Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States The Cleveland Clinic Cleveland Ohio
United States Pediatric MS Center, University of Texas, Southwestern Medical Center Dallas Texas
United States The Blue Bird Circle Clinic for MS at Texas Children's Hospital Houston Texas
United States New York University Langone Medical Center New York New York
United States Pediatric MS Clinic, Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Regional Pediatric MS Center at Mayo Clinic Rochester Minnesota
United States Pediatric MS Clinic, Washington University School of Medicine Saint Louis Missouri
United States Pediatric Neurology Clinic, Primary Children's Hospital Salt Lake City Utah
United States Pediatric MS Clinic, Children's Hospital, Loma Linda University San Bernardino California
United States UCSF Pediatric MS Center San Francisco California
United States Pediatric MS Clinic, Children's National Medical Center Washington District of Columbia

Sponsors (17)

Lead Sponsor Collaborator
University of California, San Francisco Ann & Robert H Lurie Children's Hospital of Chicago, Boston Children’s Hospital, Children's Hospital Colorado, Children's Hospital of Philadelphia, Children's National Med Center, Loma Linda University, Massachusetts General Hospital, Mayo Clinic, New York University, Primary Children's Hospital, State University of New York at Buffalo, Texas Children's Hospital, The Cleveland Clinic, University of Alabama at Birmingham, University of Texas, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identify risk factors and their respective contribution to developing pediatric multiple sclerosis The primary objective of this study is to determine if risk factors identified for adult MS such as HLA-DRB1*1501/1503, EBV, 25(OH) vitamin D3 insufficiency, and exposure to cigarette smoking are also risk factors for pediatric MS, and if there are interactions between them analyzing data collected from questionnaires for environmental exposure, demographic and food frequency as well as sample blood specimens. 4 year data collection, 1 year analysis
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