Healthy VolunteerNCT02996084
MS PATHS Normative Sub-Study
An observational study of Healthy Volunteer, run by Biogen at 6 sites in 3 countries.
Trial summary
The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- How many people
- 246 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 12 Dec 2017to 31 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy control (HC) participants enrolled at each institution will be carefully selected to result in a group whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with MS enrolled in MS PATHS at that center. Patients enrolled in MS PATHS at each center will be encouraged to enlist a friend or family member to participate in the study as an HC. Subsequently, on approximately quarterly review of participant participation, particular demographic groups will be targeted for recruitment, if needed, in order for the age, race, and gender distribution of a center's HC sample to be similar to their MS PATHS participant sample (within the study age range).
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 protected health information in accordance with national and local participant privacy regulations.
Who cannot join
- History of human immunodeficiency virus.
- Confirmed or suspected pregnancy.
- Diagnosis of migraine requiring medication or any other participant-reported diagnosis of a neurological disease or condition (e.g., stroke, transient ischemic attack, epilepsy, brain infection, brain surgery, prior head injury or concussion, or brain tumor).
- Any participant-reported diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, Sjögren's syndrome, scleroderma, or systemic lupus erythematosus).
- Standard MRI exclusion criteria, including claustrophobia, inability to lay still in the magnet (e.g., tremor), or any type of implanted metal in the body that would be affected by the strong magnetic field.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Rochester Medical Center
Rochester, New York, 14642
Washington University
St Louis, Missouri, 63110
Spain1 site
Multiple Sclerosis Centre of Catalonia (Cemcat) Vall d'Hebron Hospital
Barcelona
About this study
Official title: Longitudinal Brain Volume Change (and Correlates) in Healthy Control Subjects: A Normative Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.
- Conditions
- Healthy Volunteer
- Keywords
- Imaging research
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain volume
Measured by using magnetic resonance imaging (MRI) scans
Measured: Every 12 months up to 3 years
Brain volume change
Measured by using MRI scans
Measured: Every 12 months up to 3 years
Secondary outcomes (1)
Development of models to calibrate brain volume measurements between centers, if necessary
Measured by using MRI scans
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start12 Dec 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 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
- NCT02996084
- Sponsor's protocol ID
- 888MS005
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2016
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Brain Volume Change (and Correlates) in Healthy Control Subjects: A Normative Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
- ClinicalTrials.gov ID
- NCT02996084
- Acronym / sponsor ID
- 888MS005
- Conditions
- Healthy Volunteer
- Keywords
- Imaging research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Dec 2016 (estimated)
- 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 of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy control (HC) participants enrolled at each institution will be carefully selected to result in a group whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with MS enrolled in MS PATHS at that center. Patients enrolled in MS PATHS at each center will be encouraged to enlist a friend or family member to participate in the study as an HC. Subsequently, on approximately quarterly review of participant participation, particular demographic groups will be targeted for recruitment, if needed, in order for the age, race, and gender distribution of a center's HC sample to be similar to their MS PATHS participant sample (within the study age range).
Key inclusion criteria (1 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations.
Key exclusion criteria (6 listed)
- History of human immunodeficiency virus.
- Confirmed or suspected pregnancy.
- Diagnosis of migraine requiring medication or any other participant-reported diagnosis of a neurological disease or condition (e.g., stroke, transient ischemic attack, epilepsy, brain infection, brain surgery, prior head injury or concussion, or brain tumor).
- Any participant-reported diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, Sjögren's syndrome, scleroderma, or systemic lupus erythematosus).
- Standard MRI exclusion criteria, including claustrophobia, inability to lay still in the magnet (e.g., tremor), or any type of implanted metal in the body that would be affected by the strong magnetic field.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain volume
Time frame: Every 12 months up to 3 years
Measured by using magnetic resonance imaging (MRI) scans
Brain volume change
Time frame: Every 12 months up to 3 years
Measured by using MRI scans
1 secondary outcome
Development of models to calibrate brain volume measurements between centers, if necessary
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
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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
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, run by Biogen at 6 sites in 3 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brain volume (time frame: Every 12 months up to 3 years). The study lists 2 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 24 Feb 2023.