Multiple SclerosisNCT03926637
Feasibility of the Multiple Sclerosis Performance Test in Participants With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Biogen at 33 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Multiple Sclerosis Performance Test (MSPT)
- How many people
- 3,073 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 17 Jun 2019to 5 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States22 sites
Research Site
Atlanta, Georgia, 30309
Research Site
Atlanta, Georgia, 30327
Research Site
Aurora, Colorado, 80045
Research Site
Berkeley, California, 94705
Research Site
Boston, Massachusetts, 02215
Research Site
Buffalo, New York, 14202
Research Site
Chicago, Illinois, 60008
Research Site
Dallas, Texas, 75390-8806
Research Site
Durham, North Carolina, 27710
Research Site
Farmington Hills, Michigan, 48334
Research Site
Los Angeles, California, 90033-5310
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Owosso, Michigan, 48867
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Portland, Oregon, 97225
Research Site
Salt Lake City, Utah, 84103
Research Site
Seattle, Washington, 98122
Research Site
Spokane, Washington, 99208
Research Site
St Louis, Missouri, 63131
Research Site
Teaneck, New Jersey, 07666
Research Site
Washington D.C., District of Columbia, 20007
Italy5 sites
Research Site
Bari, 70124
Research Site
Catania, 95123
Research Site
Milan, 20132
Research Site
Orbassano, 10043
Research Site
Roma, 00185
United Kingdom2 sites
Research Site
Camberley, GU16 7UJ
Research Site
Oxford, OX3 9DU
About this study
Official title: Feasibility of the Multiple Sclerosis Performance Test for Assessment of Functional Performance Measures in Patients With Multiple Sclerosis
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).
- Conditions
- Multiple Sclerosis
- Being tested
- Multiple Sclerosis Performance Test (MSPT)
- Keywords
- Clinically Isolated Syndrome
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Sclerosis Performance Test (MSPT)Other
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Participants with MS, including CIS will complete the MSPT at their standard of care visits. Receives: Other: Multiple Sclerosis Performance Test (MSPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Completing All Modules
Measured: Baseline to Month 24
Percentage of Participants Completing Each Individual Module
Measured: Baseline to Month 24
Percentage of Participants Skipping Modules
Measured: Baseline to Month 24
Average Time to Complete the Multiple Sclerosis Performance Test (MSPT)
Measured: Baseline to Month 24
Average Time to Complete Individual MSPT Modules
Measured: Baseline to Month 24
Frequency of Reasons for Not Completing MSPT Modules
Measured: Baseline to Month 24
Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules
Measured: Baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start17 Jun 2019
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Why it stopped: Biogen will stop any further development of the MSPT. The data collected thus far in the MSPT Feasibility Study allow us to answer the primary study objectives that are associated with assessing the feasibility of the MSPT in a clinical care setting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926637
- Sponsor's protocol ID
- US-MSG-18-11424
- Status last verified
- Jan 2023
- First submitted
- 22 Apr 2019
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Multiple Sclerosis Performance Test for Assessment of Functional Performance Measures in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03926637
- Acronym / sponsor ID
- US-MSG-18-11424
- Conditions
- Multiple Sclerosis
- Keywords
- Clinically Isolated Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Biogen will stop any further development of the MSPT. The data collected thus far in the MSPT Feasibility Study allow us to answer the primary study objectives that are associated with assessing the feasibility of the MSPT in a clinical care setting.
- Enrolment
- 3,073 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Other: Multiple Sclerosis Performance Test (MSPT)Participants with MS, including CIS will complete the MSPT at their standard of care visits. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Sclerosis Performance Test (MSPT)Administered as specified in the treatment arm. | Other | Study Participants |
Primary outcome
Percentage of Participants Completing All Modules
Time frame: Baseline to Month 24
Percentage of Participants Completing Each Individual Module
Time frame: Baseline to Month 24
Percentage of Participants Skipping Modules
Time frame: Baseline to Month 24
Average Time to Complete the Multiple Sclerosis Performance Test (MSPT)
Time frame: Baseline to Month 24
Average Time to Complete Individual MSPT Modules
Time frame: Baseline to Month 24
Frequency of Reasons for Not Completing MSPT Modules
Time frame: Baseline to Month 24
Frequency Distribution of Demographic Characteristics of Participants Failing to Complete Specific MSPT Modules
Time frame: Baseline to Month 24
Results and safety
The study was stopped early (reason given: Biogen will stop any further development of the MSPT. The data collected thus far in the MSPT Feasibility Study allow us to answer the primary study objectives that are associated with assessing the feasibility of the MSPT in a clinical care setting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Biogen at 33 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Italy, Switzerland, United Kingdom, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Biogen will stop any further development of the MSPT. The data collected thus far in the MSPT Feasibility Study allow us to answer the primary study objectives that are associated with assessing the feasibility of the MSPT in a clinical care setting.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Completing All Modules (time frame: Baseline to Month 24). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.