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MS PATHS Normative Sub-Study

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ClinicalTrials.gov Identifier: NCT02996084
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.

Condition or disease
Healthy Volunteer

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Brain Volume Change (and Correlates) in Healthy Control Subjects: A Normative Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Brain volume [ Time Frame: Every 12 months up to 3 years ]
    Measured by using magnetic resonance imaging (MRI) scans

  2. Brain volume change [ Time Frame: Every 12 months up to 3 years ]
    Measured by using MRI scans


Secondary Outcome Measures :
  1. Development of models to calibrate brain volume measurements between centers, if necessary [ Time Frame: Up to 3 years ]
    Measured by using MRI scans


Biospecimen Retention:   Samples Without DNA
Ribonucleic acid (RNA), serum, and whole blood biomarker samples


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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy control (HC) participants enrolled at each institution will be carefully selected to result in a group whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with MS enrolled in MS PATHS at that center. Patients enrolled in MS PATHS at each center will be encouraged to enlist a friend or family member to participate in the study as an HC. Subsequently, on approximately quarterly review of participant participation, particular demographic groups will be targeted for recruitment, if needed, in order for the age, race, and gender distribution of a center's HC sample to be similar to their MS PATHS participant sample (within the study age range).
Criteria

Key Inclusion Criteria

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations.

Key Exclusion Criteria

  • History of human immunodeficiency virus.
  • Confirmed or suspected pregnancy.
  • Diagnosis of migraine requiring medication or any other participant-reported diagnosis of a neurological disease or condition (e.g., stroke, transient ischemic attack, epilepsy, brain infection, brain surgery, prior head injury or concussion, or brain tumor).
  • Any participant-reported diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, Sjögren's syndrome, scleroderma, or systemic lupus erythematosus).
  • Standard MRI exclusion criteria, including claustrophobia, inability to lay still in the magnet (e.g., tremor), or any type of implanted metal in the body that would be affected by the strong magnetic field.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996084


Contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02996084     History of Changes
Other Study ID Numbers: 888MS005
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018

Keywords provided by Biogen:
Imaging research