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MS PATHS Normative Sub-Study

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ClinicalTrials.gov Identifier: NCT02996084
Recruitment Status : Active, not recruiting
First Posted : December 19, 2016
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date December 15, 2016
First Posted Date December 19, 2016
Last Update Posted Date January 6, 2021
Actual Study Start Date December 12, 2017
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 15, 2016)
  • Brain volume [ Time Frame: Every 12 months up to 3 years ]
    Measured by using magnetic resonance imaging (MRI) scans
  • Brain volume change [ Time Frame: Every 12 months up to 3 years ]
    Measured by using MRI scans
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 17, 2017)
Development of models to calibrate brain volume measurements between centers, if necessary [ Time Frame: Up to 3 years ]
Measured by using MRI scans
Original Secondary Outcome Measures
 (submitted: December 15, 2016)
Development of models to calibrate brain volume measurements between centers, if necessary [ Time Frame: Up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MS PATHS Normative Sub-Study
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Ribonucleic acid (RNA), serum, and whole blood biomarker samples
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).
Condition Healthy Volunteer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 15, 2016)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 15, 2022
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02996084
Other Study ID Numbers 888MS005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biogen
Study Sponsor Biogen
Collaborators Not Provided
Investigators
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date January 2021