Frontlight ResearchEarly access
Taking people in ItalyPhase 4
Tests ozanimod in adults with relapsing-remitting multiple sclerosis over 2 years
Studies whether ozanimod slows brain nerve damage in relapsing-remitting multiple sclerosis.
Key facts
- Who runs it
- Ospedale San Raffaele S.r.l.
- Where
- Milan, ItalySee the site
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 30 people, planned
- Started
- 22 Jun 2022
- Expected to end
- 28 Feb 2028
- Type of study
- Interventional
- Record updated
- 24 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. 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
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- For RRMS patients: Age <18 or >55 years
- For HC subjects: Age <18 or >55 years
- 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])
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Italy
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests ozanimod in adults with relapsing-remitting multiple sclerosis over 2 yearsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Fit questions
- Built from 2024-513960-24-00, who can take part
- Record updated
- 24 June 2026