MS PATHS Normative Sub-Study

Status:	Recruiting
Conditions:	Healthy Studies, Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	21 - 60
Updated:	9/14/2018
Start Date:	December 12, 2017
End Date:	December 15, 2020
Contact:	US Biogen Clinical Trial Center
Email:	clinicaltrials@biogen.com
Phone:	866-633-4636

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)

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.

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

We found this trial at

sites

Cleveland Clinic Foundation

2049 E 100th St
Cleveland, Ohio 44106

(216) 444-2200