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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04907305
Other study ID # MS200077_0013
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 2, 2021
Est. completion date February 19, 2024

Study information

Verified date May 2024
Source EMD Serono
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINKā„¢ Outcomes Study (NCT04735406). The study aims to examine the effects of using feed forward Patient Reported Outcomes (PROs) data in real-world Multiple Sclerosis (MS) care settings. The study will be conducted within an emerging Learning Healthcare System (LHS).


Recruitment information / eligibility

Status Terminated
Enrollment 1594
Est. completion date February 19, 2024
Est. primary completion date February 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants willing and able to provide written informed consent - Participants with clinical diagnosis of Multiple Sclerosis (MS) Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Atlanta Neuroscience Institute Atlanta Georgia
United States The University of Texas of Austin Austin Texas
United States Alabama Neurology Associates Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Oklahoma Medical Research Foundation Oklahoma City Oklahoma
United States The Memorial Hospital, d.b.a Memorial Healthcare Owosso Michigan
United States The University of Texas Health Science Center San Antonio Texas
United States Georgetown University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
EMD Serono Research & Development Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14) Baseline up to 18 Months
Secondary Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 Months Baseline up to 18 Months
See also
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Completed NCT02739542 - Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS) Phase 4
Completed NCT03177655 - Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis N/A
Active, not recruiting NCT04777539 - Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
Recruiting NCT02352194 - Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis N/A
Completed NCT02308579 - Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases N/A
Completed NCT02019927 - Electric Stimulation of the Eye to Improve Vision After Trauma N/A