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 range18 Years
SexALL
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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
✕. 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.
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.