An Observational Biomarker Study in Multiple Sclerosis (MS) Patients (NCT05663853) | Clinical Trial Compass
CompletedNot Applicable
An Observational Biomarker Study in Multiple Sclerosis (MS) Patients
United States137 participantsStarted 2023-03-28
Plain-language summary
All males and females between 18-70 years of age regardless of their race and ethnicity with a confirmed diagnosis of Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), and Relapse Remitting Multiple Sclerosis (RRMS) are invited to participate in this Observational study being conducted across four sites in the US. Since this is an observational study no medication/drug or treatment will be given to the participants. The investigator will be collecting information about the participant's MS disease, its progression, current medications, radiographic scans, and blood samples. This will help the investigator evaluate the biomarkers and new treatment options to better understand the MS disease process.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects with a confirmed diagnosis of different types of Multiple Sclerosis (MS) namely PPMS, SPMS, and RRMS, by the revised 2017 McDonald criteria.
. Male or female MS subjects aged 18 -70 years.
. Body Mass Index (BMI) 18.0-35.0 kg/m2 at screening.
. Subjects have undergone 1.5T and/or 3T MRI brain and /or spinal cord with or without contrast within the past 6 months.
. Subject, or their legally authorized representative/guardian, must be willing and able to provide written informed consent prior to initiation of any study procedures.
. Subjects who are willing and able to adhere to study protocol requirements including but not limited to scheduled visits and laboratory tests.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collect clinical information pertaining to MS disease
Timeframe: 1 year
2
Collect radiographical data
Timeframe: 1 year
3
Collect patient demographic data
Timeframe: 1 year
4
Evaluate factors affecting the pharmacological response to LAPIX's lead immune-tolerance restoration molecule ex-vivo.
. Subjects diagnosed with Clinically Isolated syndrome (CIS) which describes the first episode of neurological symptoms that last at least 24 hours caused by inflammation or demyelination in the central nervous system. It usually occurs in young adults and affects optic nerves, the brainstem, or the spinal cord.
. Subjects with a confirmed diagnosis of NMOSD by the 2015 International Panel for NMO Diagnosis (IPND) criteria.
. Subjects with a confirmed diagnosis of MOGAD by meeting the following criteria:
. Laboratory finding serum positive MOG-IgG by cell-based assay.
. Clinical findings of any of the following presentations:
. Subjects with Grade-3 lymphocytopenia (\<500-200 /mm3 or \<0.5-0.2\* 10e9/L) over the past 6 months.
. COVID-19:
. Blood loss of \>250 mL or donated blood within 56 days, or donated plasma within 7 days, of study screening.