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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926637
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

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 Intervention/treatment
Multiple Sclerosis Other: Multiple Sclerosis Performance Test (MSPT)

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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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort 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.




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 ]


Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926637


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

Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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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: April 24, 2019
Last Verified: April 2019
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/

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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:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases