Serum Neurofilament Light in Multiple Sclerosis

February 12, 2025 updated by: Dent Neuroscience Research Center

Serum Neurofilament Light As a Clinical Tool in Relapsing Remitting Multiple Sclerosis

This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with relapsing remitting multiple sclerosis.

Description

Inclusion Criteria:

  1. Patients diagnosed with RRMS
  2. Adults aged 18+ at time of screening
  3. Patients who are able to consent
  4. Patients who agree to be reasonably compliant with study protocol for the duration of the study
  5. Any subject who is currently being treated with an MS DMT or any subject initiating a new MS DMT throughout the duration of their participation in the study will be initiated and/or treated according to local label

Exclusion Criteria:

  1. Patients with current diagnosis of a neurodegenerative or autoimmune disease other than MS that may impact sNfL levels, in the opinion of the investigator (including but not limited to: Alzheimer's disease, Huntington's disease, Amyotrophic Lateral Sclerosis, or Parkinson's disease, systemic lupus erythematosus, rheumatoid arthritis)
  2. Inability to complete blood draws
  3. Pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study
  4. Patients who have taken an investigational medication within five half-lives prior to screening or who plan to take an investigational medication during the study
  5. Patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' understanding of patient's clinical status before sNfL results are received vs. after sNfL results are received
Time Frame: 1 year
This outcome is based on structured clinician questionnaires developed for this study. Prior to receiving patient sNfL results, clinicians will answer the question "My current clinical impression of this patient's disease status is (circle one): a. Stable, b. Suspected disease activity, c. Confirmed disease activity, d. At risk for relapse, e. Relapse, f. Other (please specify)." After receiving patient sNfL results, clinicians will answer the question "After reviewing this patient's sNfL results along with other diagnostic testing at this time, my opinion of the patient's disease status is (circle one): a. Stable, b. Suspected disease activity, c. Confirmed disease activity, d. At risk for relapse, e. Relapse, f. Other (please specify)" and these answers will be reported.
1 year
Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' opinion as to how sNfL results could guide clinical practice
Time Frame: 1 year
This outcome is based on a structured clinician questionnaire developed for this study. Clinicians will answer the question: "This patient's sNfL results have had the following impact on my opinions or confidence in this patient's care plan, or have potential to guide my clinical practice in the following way (please list specifics, e.g., increased confidence in assessment of disease status; decision to order additional testing; change in mediation therapy; change in frequency of follow-up, etc)" and these answers will be reported.
1 year
Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements.
Time Frame: 1 year
1 year
Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements.
Time Frame: 1 year
This outcome is based on a structured clinician questionnaire developed for this study. Prior to receiving patient's sNfL results, clinicians will answer the question, "Is this an unscheduled sNfL measurement? Yes No; If yes, please specify reason why this sNfL measurement was scheduled" and these answers will be reported.
1 year
Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.
Time Frame: 1 year
After receiving sNfL results, clinicians will answer the following prompt on a visual analog scale: "Knowledge of sNfL level has the potential to be useful in my clinical practice for this patient" and these answers will be reported. The scale is measured from "Not at all" to "extremely."
1 year
Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.
Time Frame: 1 year
After receiving sNfL results, clinicians will answer the following prompt on a visual analog scale: "sNfL results has the potential to be a useful/suitable alternative to MRI for this patient" and these answers will be reported. The scale is measured from "Not at all" to "extremely."
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Describe patient demographics
Time Frame: 1 year
1 year
Describe patient comorbidities
Time Frame: 1 year
1 year
Describe patient concomitant medications
Time Frame: 1 year
1 year
Describe patient MS medications
Time Frame: 1 year
1 year
Describe patient reasons for MS medication changes
Time Frame: 1 year
1 year
Describe patient MS relapses including date of relapse
Time Frame: 1 year
1 year
Describe patient MS relapses including clinical findings
Time Frame: 1 year
1 year
Describe patient MS relapses including radiologic findings
Time Frame: 1 year
1 year
Describe patient MS relapses including severity
Time Frame: 1 year
Severity of MS relapses will be described by change in EDSS score from non-relapsing EDSS measurement.
1 year
Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
Time Frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more accessible: ____________ " and these answers will be reported.
1 year
Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
Time Frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more burdensome: ___________" and these answers will be reported.
1 year
Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
Time Frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were more uncomfortable: ___________" and these answers will be reported.
1 year
Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
Time Frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL draws were easier to fit into my schedule: ____________" and these answers will be reported.
1 year
Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire.
Time Frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? Compared to MRI, sNfL results were more difficult to understand: ____________" and these answers will be reported.
1 year
Explore patient attitudes towards sNfL measurements by capturing patients' understanding of their disease before sNfL results are received vs. after sNfL results are received via a structured questionnaire.
Time Frame: 1 year
This outcome is based on structured patient questionnaires developed for this study. Patients will answer the following question before and after receiving sNfL results: "My current understanding of my MS disease is that I am (circle one): a. Stable, b. Experiencing increased disease activity, c. At risk for relapse, d. Experiencing a relapse, e. Unknown" and these answers will be reported.
1 year
Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.
Time Frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? sNfL results were easy to understand: _______" and these results will be reported.
1 year
Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.
Time Frame: 1 year
This outcome is based on a structured patient questionnaire developed for this study. Patients will answer the following question after receiving sNfL results: "How much do you agree with the following statements on a scale of 0 to 10, where 0 is "completely disagree" and 10 is "completely agree"? sNfL results increased my knowledge of my MS disease status: ____________" and these results will be reported.
1 year
Compare sNfL levels after initiation of a new MS disease-modifying therapy (DMT; when patient is treated with a DMT) vs. prior to MS DMT initiation (when patient is not treated with any DMT) where available.
Time Frame: 1 year
1 year
Compare sNfL levels at scheduled sampling time points between patients initiating any new MS DMT vs. patients who do not change MS DMT where available.
Time Frame: 1 year
1 year
Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not.
Time Frame: 1 year
1 year
Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
Time Frame: 1 year
EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS.
1 year
Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
Time Frame: 1 year
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
1 year
Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
Time Frame: 1 year
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
1 year
Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
Time Frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
1 year
Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
Time Frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
1 year
Describe changes in sNfL levels with magnetic resonance imaging disease activity where available.
Time Frame: 1 year
1 year
Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
Time Frame: 1 year
1 year
Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
Time Frame: 1 year
EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS.
1 year
Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
Time Frame: 1 year
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
1 year
Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
Time Frame: 1 year
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
1 year
Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
Time Frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
1 year
Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
Time Frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
1 year
Compare changes in sNfL levels with magnetic resonance imaging disease activity where available.
Time Frame: 1 year
1 year
Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
Time Frame: 1 year
1 year
Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
Time Frame: 1 year
1 year
Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
Time Frame: 1 year
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
1 year
Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
Time Frame: 1 year
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
1 year
Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
Time Frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
1 year
Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
Time Frame: 1 year
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
1 year
Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available.
Time Frame: 1 year
1 year
Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dent Neuroscience Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG
Monogram Biosciences (LabCorp Specialty Testing Group)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML 45098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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