MS PATHS Normative Sub-Study

Completed

• Conditions: Healthy Volunteer

• Registration Number: NCT02996084
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-19
• Study Start: 2017-12-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain volume	Every 12 months up to 3 years	Measured by using magnetic resonance imaging (MRI) scans
Brain volume change	Every 12 months up to 3 years	Measured by using MRI scans

Secondary Outcome Measures

Name	Time	Method
Development of models to calibrate brain volume measurements between centers, if necessary	Up to 3 years	Measured by using MRI scans

Trial Locations

Locations (6)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Multiple Sclerosis Centre of Catalonia (Cemcat) Vall d'Hebron Hospital; 🇪🇸 Barcelona, Spain

University Hospital Carl Gustav Carus Dresden; 🇩🇪 Dresden, Germany

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States