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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis

Clinicaltrials.gov identifier NCT03926637

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted February 5, 2020

Study Description

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).

  • Condition or Disease:Multiple Sclerosis
  • Intervention/Treatment: Other: Multiple Sclerosis Performance Test (MSPT)
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 5000 participants
  • Observational Model: Case-Only
  • Time Perspective: Prospective
  • Official Title: Feasibility of the Multiple Sclerosis Performance Test for Assessment of Functional Performance Measures in Patients With Multiple Sclerosis
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: September 2022
  • Estimated Study Completion Date: February 2023
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Study Participants
Participants with MS, including CIS will complete the MSPT at their standard of care visits.
Other: Multiple Sclerosis Performance Test (MSPT)
Administered as specified in the treatment arm.
Outcome Measures
  • Primary Outcome Measures: 1. Percentage of Participants Completing All Modules [ Time Frame: Baseline to Month 24 ]
  • 2. Percentage of Participants Completing Each Individual Module [ Time Frame: Baseline to Month 24 ]
  • 3. Percentage of Participants Skipping Modules [ Time Frame: Baseline to Month 24 ]
  • 4. Average Time to Complete the Multiple Sclerosis Performance Test (MSPT) [ Time Frame: Baseline to Month 24 ]
  • 5. Average Time to Complete Individual MSPT Modules [ Time Frame: Baseline to Month 24 ]
  • 6. Frequency of Reasons for Not Completing MSPT Modules [ Time Frame: Baseline to Month 24 ]
  • 7. Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules [ Time Frame: Baseline to Month 24 ]
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-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.
Criteria

Key Inclusion Criteria:

- 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).

Key Exclusion Criteria:

- 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
Contacts

Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com

Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
Show 44 Study Locations
Sponsors and Collaborators

Biogen

Investigators

Study Director: Medical Director Biogen

More Information
  • Responsible Party: Biogen
  • ClinicalTrials.gov Identifier: NCT03926637 History of Changes
  • Other Study ID Numbers: US-MSG-18-11424
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: February 5, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
  • URL: http://www.biogenclinicaldatarequest.com/
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Biogen: Clinically Isolated Syndrome
  • Additional relevant MeSH terms: Sclerosis Multiple Sclerosis