What side effects are associated with this type of intervention?

The most common treatments for Multiple Sclerosis (MS) include interferon beta-1a, glatiramer acetate, and natalizumab. Interferon beta-1a can cause flu-like symptoms, injection site reactions, and liver enzyme abnormalities. Glatiramer acetate is associated with injection site reactions, lipoatrophy, and immediate post-injection reactions such as flushing and chest pain. Natalizumab carries a risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection, and can also cause infusion-related reactions and hypersensitivity.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS) that target various aspects of the immune system. Notable drugs include glatiramer acetate, which modulates the immune response by mimicking myelin basic protein, and natalizumab, which inhibits immune cell migration into the central nervous system by targeting the alpha-4 integrin. Other approved treatments include interferon beta formulations, which reduce inflammation and modulate immune activity, and fingolimod, which traps immune cells in lymph nodes. These treatments align with the goals of the SOMAscan Assay trial, which aims to identify protein biomarkers in CSF to better understand and treat MS.

What other types of research exist?

Promising novel alternatives to the SOMAscan assay for identifying and quantifying protein biomarkers in CSF for Multiple Sclerosis patients include: 1) Mass spectrometry-based proteomics, which offers high sensitivity and specificity for protein detection and quantification. 2) Next-generation sequencing (NGS) technologies for transcriptomic and proteomic analysis, providing comprehensive insights into biomarker profiles. 3) Immunoassay-based multiplex platforms, such as Luminex xMAP technology, which allow simultaneous detection of multiple biomarkers with high throughput and accuracy.

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SOMAscan Diagnostic Test for Multiple Sclerosis (SPINCOMS Trial)

N/A

Waitlist Available

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

SPINCOMS Trial Summary

This trial will test if a new medical test is able to accurately detect Multiple Sclerosis and other diseases of the central nervous system.

Who is the study for?

This trial is for individuals with Multiple Sclerosis (MS) who can attend in-person follow-ups and have had a lumbar puncture. They should be untreated at the time of the lumbar puncture, not on steroids for at least one month, and able to consent to future research use of their samples. Participants must also meet the 2017 McDonald criteria for MS diagnosis.Check my eligibility

What is being tested?

The study is using SOMAscan assay technology to analyze cerebrospinal fluid (CSF) samples from MS patients. It aims to find biomarkers that help detect differences between MS subtypes and other CNS diseases, as well as predict disease progression and treatment response.See study design

What are the potential side effects?

Since this trial involves CSF testing rather than drug intervention, typical medication side effects are not applicable. However, participants may experience discomfort or complications related to the lumbar puncture procedure.

SPINCOMS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Biomarker Predicted Outcomes against NeurEx-based outcomes

MS Severity Model Analyses

SPINCOMS Trial Design

4Treatment groups

Experimental Treatment

Group I: Relapsing Remitting Multiple SclerosisExperimental Treatment1 Intervention

Blood sample collection Vital signs, weight, height and BMI. Complete neurological examination documented in NeurEx (recorded with an iPAD). Clinical data questionnaire 25FW & non-dominant hand 9HPT (required for calculating CombiWISE & MS-DSS). Smartphone Apps (include 25FW, SDMT and tests that correlate highly w 9HPT - can be acquired in patient-autonomous manner with minimal assistance). Optical Coherence Tomography (OCT) CSF Analysis

Group II: Progressive Multiple SclerosisExperimental Treatment1 Intervention

Group III: Other Non-Inflammatory Neurological DiseasesExperimental Treatment1 Intervention

Clinical data questionnaire CSF Analysis

Group IV: Non-Inflammatory Neurological DiseasesExperimental Treatment1 Intervention

Clinical data questionnaire CSF Analysis

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) work through various mechanisms to modulate the immune system and reduce inflammation. Dimethyl fumarate activates the Nrf2 pathway, providing neuroprotection and reducing oxidative stress. Glatiramer acetate mimics myelin basic protein, distracting the immune system from attacking myelin. Natalizumab blocks the adhesion molecule α4-integrin, preventing immune cells from crossing the blood-brain barrier and causing inflammation. Alemtuzumab targets CD52 on lymphocytes, depleting these immune cells to reduce autoimmune activity. Understanding these mechanisms is crucial for MS patients as it helps tailor treatments to individual needs and predict responses, which is the focus of biomarker studies like the SOMAscan Assay.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,944 Previous Clinical Trials

2,304,333 Total Patients Enrolled

15 Trials studying Multiple Sclerosis

52,122 Patients Enrolled for Multiple Sclerosis

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,277 Previous Clinical Trials

5,487,293 Total Patients Enrolled

16 Trials studying Multiple Sclerosis

4,134 Patients Enrolled for Multiple Sclerosis

University of Colorado, DenverOTHER

1,749 Previous Clinical Trials

2,163,900 Total Patients Enrolled

20 Trials studying Multiple Sclerosis

2,607 Patients Enrolled for Multiple Sclerosis

Media Library

SOMAscan Clinical Trial Eligibility Overview. Trial Name: NCT04496830 — N/A

Multiple Sclerosis Research Study Groups: Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Non-Inflammatory Neurological Diseases, Other Non-Inflammatory Neurological Diseases

Multiple Sclerosis Clinical Trial 2023: SOMAscan Highlights & Side Effects. Trial Name: NCT04496830 — N/A

SOMAscan 2023 Treatment Timeline for Medical Study. Trial Name: NCT04496830 — N/A

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