Status:
UNKNOWN
Effects of Ozanimod on Immune-mediated Mechanisms of Neurodegeneration in Multiple Sclerosis - a Preclinical Study
Lead Sponsor:
Neuromed IRCCS
Collaborating Sponsors:
University of Rome Tor Vergata
Conditions:
Relapsing-Remitting Multiple Sclerosis (RRMS)
Neuromyelitis Optica
Eligibility:
All Genders
18-55 years
Brief Summary
This is a prospective non interventional study including patients with Relapsing-Remitting Multiple Sclerosis (RRMS) or with Neuromyelitis Optica Spectrum Disorders (NMOSD) and healthy subjects, who a...
Detailed Description
Multiple sclerosis (MS) is a multifactorial and complex disease with several and tangled pathophysiological mechanisms, responsible for the inflammatory and neurodegenerative damage. Therapies targeti...
Eligibility Criteria
Inclusion
- Main inclusion criteria of patients with RRMS:
- Relapsing-remitting MS, as diagnosed by the revised 2010 McDonald Criteria
- EDSS score ≤ 5.5;
- Age between 18 and 55 years (exclusive);
- No disease modifying therapies for at least 3 months or treatment naïve;
- No corticosteroid administration in the previous month;
- Disease duration \<10 years;
- Ability to provide written informed consent.
- For the estimation of radiological variables, brain and spinal cord MRI will be performed according to clinical practice and lesions will be classified as symptomatic or asymptomatic if they were associated with clinical relapse or not.
- Patient groups will be matched by gender, age, ethnicity and MS duration.
- Main inclusion criteria of patients with NMOSD (Wingerchuk et al., 2015):
- Positive test for Aquaporin 4 IgG;
- Age between 18 and 55 years (exclusive);
- no immunosuppressive therapies for at least 3 months or treatment naïve
- no corticosteroid administration in the previous month
- disease duration \<10 years
- Ability to provide written informed consent
- Healthy subjects
- Age between 18 and 55 years (exclusive), matched by gender, age and ethnicity towards the MS groups.
- Ability to provide written informed consent
Exclusion
- Exclusion criteria patients with RRMS:
- Adverse effects to MRI imaging with i.v. gadolinium;
- Blood count basal alteration;
- Clinically significant medical condition other than MS, including latent infections (e.g. tuberculosis, viral hepatitis, HIV/AIDS) that might confound the results of the study.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05245344
Start Date
April 1 2022
End Date
October 31 2023
Last Update
February 17 2022
Active Locations (3)
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1
IRCCS INM-Neuromed
Pozzilli, Isernia, Italy, 86077
2
IRCCS Ospedale Policlinico San Martino
Genova, Italy
3
Centre for Experimental Neurological Therapies (CENTERS), Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome
Roma, Italy