MS PATHS Normative Sub-Study

Healthy Volunteer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996084
• Other study ID #: 888MS005
• Status: Completed
• Start date: December 12, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Locations

Country	Name	City	State
Germany	University Hospital Carl Gustav Carus Dresden	Dresden
Spain	Multiple Sclerosis Centre of Catalonia (Cemcat) Vall d'Hebron Hospital	Barcelona
United States	Johns Hopkins University	Baltimore	Maryland
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Rochester Medical Center	Rochester	New York
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain volume	Measured by using magnetic resonance imaging (MRI) scans	Every 12 months up to 3 years
Primary	Brain volume change	Measured by using MRI scans	Every 12 months up to 3 years
Secondary	Development of models to calibrate brain volume measurements between centers, if necessary	Measured by using MRI scans	Up to 3 years