NCT03926637

Brief Summary

The primary objective is to evaluate the feasibility of the Multiple Sclerosis Performance Test (MSPT) in a clinical care setting when used by participants with Multiple Sclerosis (MS).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,073

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
6 countries

33 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2022

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

3.5 years

First QC Date

April 22, 2019

Last Update Submit

January 27, 2023

Conditions

Keywords

Clinically Isolated Syndrome

Outcome Measures

Primary Outcomes (7)

  • Percentage of Participants Completing All Modules

    Baseline to Month 24

  • Percentage of Participants Completing Each Individual Module

    Baseline to Month 24

  • Percentage of Participants Skipping Modules

    Baseline to Month 24

  • Average Time to Complete the Multiple Sclerosis Performance Test (MSPT)

    Baseline to Month 24

  • Average Time to Complete Individual MSPT Modules

    Baseline to Month 24

  • Frequency of Reasons for Not Completing MSPT Modules

    Baseline to Month 24

  • Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules

    Baseline to Month 24

Study Arms (1)

Study Participants

Participants with MS, including CIS will complete the MSPT at their standard of care visits.

Other: Multiple Sclerosis Performance Test (MSPT)

Interventions

Administered as specified in the treatment arm.

Study Participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with a diagnosis of MS, including CIS will be offered study participation during their standard of care clinic visit or by contacting eligible participants identified from medical records.

You may qualify if:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations
  • Diagnosis of MS, including Clinically Isolated Syndrome
  • Ability to understand the audio and visual instructions for the test modules
  • Visual function, based on the investigator's clinical judgement that does not preclude an ability to interact with the Multiple Sclerosis Performance Test (MSPT).

You may not qualify if:

  • Unable or unwilling to provide informed consent
  • Participants younger than 18 years of age, unless their parent or legal guardian provides the required signed and dated informed consent and authorization to use confidential health information and the participant provides assent in accordance with national and local subject privacy regulations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Research Site

Berkeley, California, 94705, United States

Location

Research Site

Los Angeles, California, 90033-5310, United States

Location

Research Site

Aurora, Colorado, 80045, United States

Location

Research Site

Washington D.C., District of Columbia, 20007, United States

Location

Research Site

Atlanta, Georgia, 30309, United States

Location

Research Site

Atlanta, Georgia, 30327, United States

Location

Research Site

Chicago, Illinois, 60008, United States

Location

Research Site

Boston, Massachusetts, 02215, United States

Location

Research Site

Farmington Hills, Michigan, 48334, United States

Location

Research Site

Owosso, Michigan, 48867, United States

Location

Research Site

St Louis, Missouri, 63131, United States

Location

Research Site

Teaneck, New Jersey, 07666, United States

Location

Research Site

Buffalo, New York, 14202, United States

Location

Research Site

Durham, North Carolina, 27710, United States

Location

Research Site

Oklahoma City, Oklahoma, 73104, United States

Location

Research Site

Portland, Oregon, 97225, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15212, United States

Location

Research Site

Dallas, Texas, 75390-8806, United States

Location

Research Site

Salt Lake City, Utah, 84103, United States

Location

Research Site

Seattle, Washington, 98122, United States

Location

Research Site

Spokane, Washington, 99208, United States

Location

Research Site

Prague, 12000, Czechia

Location

Research Site

Strasbourg, 67200, France

Location

Research Site

Bari, 70124, Italy

Location

Research Site

Catania, 95123, Italy

Location

Research Site

Milan, 20132, Italy

Location

Research Site

Orbassano, 10043, Italy

Location

Research Site

Roma, 00185, Italy

Location

Research Site

Basel, 4031, Switzerland

Location

Research Site

Bern, 3010, Switzerland

Location

Research Site

Camberley, GU16 7UJ, United Kingdom

Location

Research Site

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 24, 2019

Study Start

June 17, 2019

Primary Completion

December 5, 2022

Study Completion

December 5, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

More information

Locations