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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

An Observational Biomarker Study in Multiple Sclerosis (MS) Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subjects with a confirmed diagnosis of different types of Multiple Sclerosis (MS) namely PPMS, SPMS, and RRMS, by the revised 2017 McDonald criteria. 2. Male or female MS subjects aged 18 -70 years. 3. Body Mass Index (BMI) 18.0-35.0 kg/m2 at screening. 4. Subjects have undergone 1.5T and/or 3T MRI brain and /or spinal cord with or without contrast within the past 6 months. 5. Subject, or their legally authorized representative/guardian, must be willing and able to provide written informed consent prior to initiation of any study procedures. 6. Subjects who are willing and able to adhere to study protocol requirements including but not limited to scheduled visits and laboratory tests.

Exclusion Criteria:

1. 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. 2. Subjects with a confirmed diagnosis of NMOSD by the 2015 International Panel for NMO Diagnosis (IPND) criteria. 3. Subjects with a confirmed diagnosis of MOGAD by meeting the following criteria: 1. Laboratory finding serum positive MOG-IgG by cell-based assay. 2. Clinical findings of any of the following presentations: i)Acute disseminated encephalomyelitis (ADEM) ii)Optic neuritis, including chronic relapsing optic neuropathy (CRION) iii)Transverse myelitis (short or long segment) iv)Brain or brainstem syndrome compatible with demyelination v)Any combination of the above c) Exclusion of the alternative diagnosis. 4. Subjects with Grade-3 lymphocytopenia (<500-200 /mm3 or <0.5-0.2* 10e9/L) over the past 6 months. 5. COVID-19: Subject has a known COVID-19 positive status (confirmed by clinical signs and symptoms and/or + ve SARS-CoV-2 NAAT result COVID test) during enrollment. OR has had recent COVID-19 vaccination including a booster dose in the past 30 days OR has received anti-viral therapy intended to prevent COVID-19 such as Paxlovid, remdesivir, molnupiravir, interferons, Anti-SARS-CoV-2 monoclonal antibodies, IVIG-SARS-CoV-2, COVID-19 Convalescent plasma, etc. in the past 4-6 weeks. 6. Blood loss of >250 mL or donated blood within 56 days, or donated plasma within 7 days, of study screening. 7. Subjects with acute illness such as fever (body temperature of ≥100.4°F or ≥ 38°C), vomiting, cough, or diarrhea within 48 hours before the screening period. (Upon recovery these subjects can be rescreened / re-enrolled in the study. 8. Recent vaccination with live attenuated vaccines such as influenza, MMR, Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, Rabies vaccine, etc. in the past 30 days. 9. Subject has participated in another investigational study involving any investigational product within 60 days to the start of the study, or within 5 half-lives, of the experimental drug, biologic, or device whichever is longer. 10. Subjects who have been recently diagnosed or have a documented history of HIV or HIV-related disease conditions, hepatitis B or C, or other infectious diseases. 11. History of cancer treatment with either chemo or radiation therapy or both in the past 5 years prior to enrollment in the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05663853
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

LAPIX Therapeutics Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Robert Shin, MD,FANASylvia Klineova, MD,MSShiv Saidha, MD,MRCPIRobert Bermel, MD,MBA
Principal Investigator Affiliation Prof of Neurology MedStar Georgetown University HospitalAssistant Prof of Neurology Icahn School of Medicine at Mt SinaiProf of Neurology, Johns Hopkins Hospital, Baltimore MDDirector Mellen Center for Multiple Sclerosis, Cleveland Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive
Additional Details

Multiple sclerosis (MS) is a chronic disabling disorder of the central nervous system with inflammatory etiology and genetic and environmental factors. It affects females more than males (2-3:1ratio). The National Multiple Sclerosis Society estimates 2.8 million people are affected by Multiple Sclerosis (MS) globally, with around 1 million patients in the US alone. This is an observational protocol designed to collect clinical and radiographical data and blood samples from patients with a confirmed diagnosis of multiple sclerosis (MS). The blood samples are collected to conduct research on the likelihood of response to LAPIX's novel small molecule therapy and to better understand the MS disease process. Since this is an observational study, no drug or device will be administered to the participants and randomization will not be performed. There will be no alterations/modifications to the current treatment plan or modalities of the enrolled participants. This multicenter study will be conducted across four US sites that will enroll 200 MS patients. The total duration of this observational study (including the screening period and Visit-1) will be 7 days. However, both the screening period and Visit-1 can be combined into a single visit. There will be no follow-up period.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The Johns Hopkins University, Baltimore, Maryland

Status

Recruiting

Address

The Johns Hopkins University

Baltimore, Maryland, 21205

Site Contact

Shiv Saidha, MD,MRCPI

[email protected]

6172035516

MedStar Health, Chevy Chase, Maryland

Status

Recruiting

Address

MedStar Health

Chevy Chase, Maryland, 20815

Site Contact

Jamal D Smith, MBBS, CCRP

[email protected]

202-877-3476

New York, New York

Status

Recruiting

Address

Corinne Goldsmith Dickinson Center for MS

New York, New York, 10029

Site Contact

Susan Filomena, BA

[email protected]

212-241-3841

Mellen Center, Cleveland, Ohio

Status

Not yet recruiting

Address

Mellen Center

Cleveland, Ohio, 44195

Site Contact

Emmy Drenkhan, BA

[email protected]

216-445-3671

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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