Scan-Rescan Sub-Study of MS PATHS

NCT ID: NCT04123353

Last Updated: 2019-10-10

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-11

Study Completion Date

2017-05-09

Brief Summary

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The primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants with MS. The secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each MS PATHS center.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and l local participant privacy regulations.
* Diagnosis of relapse-onset MS (relapsing-remitting or secondary progressive).
* First MS symptom within the past 1 to 30 years.

Exclusion Criteria

* Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit 1.
* Steroid treatment or suspected MS relapse within 6 weeks prior to Visit 1.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

Baltimore, Maryland, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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888MS004

Identifier Type: -

Identifier Source: org_study_id

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