Multiple SclerosisNCT06282081
Serum Neurofilament Light in Multiple Sclerosis
An observational study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, run by Dent Neuroscience Research Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Serum Neurofilament Light
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2024to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with relapsing remitting multiple sclerosis.
Who may be able to join
- Patients diagnosed with RRMS
- Adults aged 18+ at time of screening
- Patients who are able to consent
- Patients who agree to be reasonably compliant with study protocol for the duration of the study
- 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
Who cannot join
- 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)
- Inability to complete blood draws
- Pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study
- 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
- Patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Serum Neurofilament Light
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Neurofilament LightDiagnostic test
The purpose of this research is to investigate a biomarker, called serum neurofilament light (sNfL), which is measured in blood. This study will attempt to investigate whether or not sNfL is a useful tool for clinicians in patients diagnosed with relapsing remitting multiple sclerosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 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
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.
Measured: 1 year
Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements.
Measured: 1 year
Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements.
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.
Measured: 1 year
Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.
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."
Measured: 1 year
Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale.
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."
Measured: 1 year
Secondary outcomes (41)
Describe patient demographics
Measured: 1 year
Describe patient comorbidities
Measured: 1 year
Describe patient concomitant medications
Measured: 1 year
Describe patient MS medications
Measured: 1 year
Describe patient reasons for MS medication changes
Measured: 1 year
Describe patient MS relapses including date of relapse
Measured: 1 year
Describe patient MS relapses including clinical findings
Measured: 1 year
Describe patient MS relapses including radiologic findings
Measured: 1 year
Describe patient MS relapses including severity
Severity of MS relapses will be described by change in EDSS score from non-relapsing EDSS measurement.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 1 year
Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.
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.
Measured: 1 year
Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not.
Measured: 1 year
Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS.
Measured: 1 year
Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
Measured: 1 year
Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
Measured: 1 year
Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Measured: 1 year
Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Measured: 1 year
Describe changes in sNfL levels with magnetic resonance imaging disease activity where available.
Measured: 1 year
Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
Measured: 1 year
Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
EDSS scale is from 0 to 10, where 0 indicates normal neurologic exam and 10 indicates death due to MS.
Measured: 1 year
Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
Measured: 1 year
Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
Measured: 1 year
Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Measured: 1 year
Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Measured: 1 year
Compare changes in sNfL levels with magnetic resonance imaging disease activity where available.
Measured: 1 year
Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
Measured: 1 year
Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
Measured: 1 year
Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
SDMT scale is from 0 to 110, where 0 indicates none correct and 110 indicates all correct.
Measured: 1 year
Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
PHQ-9 scores from 0 to 27, where 1-4 indicates minimal depression and 20-27 indicates severe depression.
Measured: 1 year
Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available.
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Measured: 1 year
Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
MSQOL-54 scale scores range from 0 to 100 and a higher scale score indicates improved quality of life.
Measured: 1 year
Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available.
Measured: 1 year
Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start9 Apr 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
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.
- 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dent Neuroscience Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG, Monogram Biosciences (LabCorp Specialty Testing Group)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282081
- Sponsor's protocol ID
- ML 45098
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Neurofilament Light As a Clinical Tool in Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06282081
- Acronym / sponsor ID
- ML 45098
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Dent Neuroscience Research CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc., a subsidiary of F. Hoffman-La Roche AG, Monogram Biosciences (LabCorp Specialty Testing Group)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Feb 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with relapsing remitting multiple sclerosis.
Key inclusion criteria (5 listed)
- Patients diagnosed with RRMS
- Adults aged 18+ at time of screening
- Patients who are able to consent
- Patients who agree to be reasonably compliant with study protocol for the duration of the study
- 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
Key exclusion criteria (5 listed)
- 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)
- Inability to complete blood draws
- Pregnant or breastfeeding, or planning to become pregnant or breastfeed for the duration of the study
- 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
- Patients with a medical condition or taking a medication that may interfere with study endpoints in the opinion of the investigator
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 |
|---|---|---|
| Serum Neurofilament LightThe purpose of this research is to investigate a biomarker, called serum neurofilament light (sNfL), which is measured in blood. This study will attempt to investigate whether or not sNfL is a useful tool for clinicians in patients diagnosed with relapsing remitting multiple sclerosis. | Diagnostic test | – |
Primary outcome
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.
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.
Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements.
Time frame: 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.
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."
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."
41 secondary outcomes
Describe patient demographics
Time frame: 1 year
Describe patient comorbidities
Time frame: 1 year
Describe patient concomitant medications
Time frame: 1 year
Describe patient MS medications
Time frame: 1 year
Describe patient reasons for MS medication changes
Time frame: 1 year
Describe patient MS relapses including date of relapse
Time frame: 1 year
Describe patient MS relapses including clinical findings
Time frame: 1 year
Describe patient MS relapses including radiologic findings
Time frame: 1 year
Describe patient MS relapses including severity
Time frame: 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
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
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
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
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
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
Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.
Time frame: 1 year
Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire.
Time frame: 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
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
Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not.
Time frame: 1 year
Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
Time frame: 1 year
Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
Time frame: 1 year
Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
Time frame: 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
Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
Time frame: 1 year
Describe changes in sNfL levels with magnetic resonance imaging disease activity where available.
Time frame: 1 year
Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
Time frame: 1 year
Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
Time frame: 1 year
Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
Time frame: 1 year
Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
Time frame: 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
Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
Time frame: 1 year
Compare changes in sNfL levels with magnetic resonance imaging disease activity where available.
Time frame: 1 year
Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available.
Time frame: 1 year
Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available.
Time frame: 1 year
Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available.
Time frame: 1 year
Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available.
Time frame: 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
Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available.
Time frame: 1 year
Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, run by Dent Neuroscience Research Center at 1 site in United States.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
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). The study lists 6 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 14 Feb 2025.