2024-513960-24-00RecruitingPhase 4
Effects of ozanimod on myelin dynamics and neurodegeneration in patients with relapsingremitting multiple sclerosis: correlation with disease activity, cognition, fatigue,depression and quality of life
Source: EU CTIS (euclinicaltrials.eu) · Last updated 24 Jun 2026
Brief summary (registry, in English)
The primary objective of this study is to evaluate the effects of ozanimod in RRMS patients in limiting the progression of brain neurodegenerative phenomena over the course of 2 years.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 29 May 2024
- Start date
- 22 Jun 2022
- Lead sponsor
- Ospedale San Raffaele S.r.l.
- Diseases
- Multiple sclerosis
- EU CT number
- 2024-513960-24-00
- EudraCT number
- 2021-003577-63
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with relapsing-remitting multiple sclerosis (RRMS) who are starting ozanimod, plus healthy volunteers for comparison.
- Age
- 18 to 55 years (as written in the inclusion criteria).
- Sex
- Women and men can join.
- Disease stage
- RRMS, diagnosed by the 2017 McDonald criteria, with an EDSS score of 5.0.
- Earlier treatment
- Starting ozanimod treatment under EMA and AIFA criteria. Planned vaccinations must be finished before joining. No earlier ozanimod trial.
Main reasons for not taking part
- Contraindications to ozanimod
- Major other illnesses (heart, kidney, liver, bone or joint, rheumatic, other nervous system)
- History of psychiatric or mood disorders, or drug or alcohol abuse
- MRI contraindications, such as claustrophobia or metal implants
- Pregnant, breastfeeding or planning pregnancy
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For RRMS patients: MRI contraindications, including claustrophobia, pregnancy, breastfeeding or metal implants;
- For RRMS patients: One or more symptomatic treatment(s) (e.g., antidepressants, myorelaxants, psychoactive drugs) started/modified within the 3 months before ozanimod start;
- For RRMS patients: The participant has previously participated in any clinical trial of ozanimod;
Other illness
- For HC subjects: Major medical illnesses including neurological, cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;
- For HC subjects: History of psychiatric or mood disorders, or of drug or alcohol abuse;
- For RRMS patients: Major medical illnesses including neurological (apart MS), cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;
- For RRMS patients: History of psychiatric or mood disorders, or of drug or alcohol abuse;
Age
- For RRMS patients: Age <18 or >55 years;
- For HC subjects: Age <18 or >55 years;
Other
- For HC subjects: MRI contraindications;
- For HC subject: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial (positive urine ß-subunit of HCG).
- For RRMS patients: Contraindications to ozanimod treatment as reported by EMA and AIFA (if available) recommendations;
- For RRMS patients: The participant is accommodated in an institution because of a regulatory or legal order, is a prisoner, or is legally institutionalized;
- For RRMS patients: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. (positive urine ß-subunit of human chorionic gonadotropin [HCG]).
Who the study is looking for
- For RRMS patients: Age between 18 and 55 years (in line with phase III RCTs);
- For RRMS patients:A diagnosis of RRMS according to the 2017 Revisions of the McDonald criteria;
- For RRMS patients: RRMS patients starting treatment with ozanimod, according to European Medicines Agency (EMA) and Italian Medicine Agency (AIFA) criteria (if available at the moment of study initiation);
- For RRMS patients: EDSS score =5.0 (in line with phase III RCTs);
- For RRMS patients: Planned vaccinations completed prior to enrollment;
- For RRMS patients: Provide informed consent signed for participation in the trial;
- For RRMS patients: Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.* * NOTE where the use of effective contraception is a protocol requirement a section on Contraception and Pregnancy should be added to the safety reporting section with corresponding information in the Participant Information Sheet.
- For HC subjects: Age between 18 and 55 years;
- For HC subjects: Provide informed consent signed for participation in the trial.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale San Raffaele S.r.l. | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.