MS PATHS Normative Sub-Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

246 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-12

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

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).

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes