Authorised Therapeutic confirmatory (Phase III) Relapsing Remitting Multiple Sclerosis

A Phase 3 Double-blind Study to Evaluate the Efficacy and Safety of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents with Relapsing Remitting Multiple Sclerosis

EU CTIS ID: 2022-501332-42-00

What this study is testing

To test if ozanimod is effective compared to fingolimod (a different medication that can treat RRMS)

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Core Phase: Diagnosis of MS with a RRMS
Core Phase: 1 MS relapse in the previous year or 2 MS relapse in past 2 years or evidence of 1 or more growth in MRI within 6 months
Core Phase: 0 - 5.5 Expanded Disability Status Scale (EDSS)
Core Phase: Must be able to swallow capsule
Extension Phase: Completion of core phase

You likely can't join if

Core and Extension phase: Diagnosis of progressive form of MS
Core and Extension Phase: Active or chronic disease of the immune system
Core and Extension Phase: Any cardiovascular, liver, neurological, endocrine, or other major body disease or history or presence of malignancy
Core and Extension Phase: History of any type of epileptic seizures, substance abuse, progressive neurological disorder, or history of suicide attempt
Core and Extension Phase: Pregnant or breastfeeding females
Core and Extension Phase: Previous treatment with certain lymphocyte-depleting therapies or other immunosuppressants

See the full eligibility criteria

Who can join

Core Phase: Diagnosis of MS with a RRMS
Core Phase: 1 MS relapse in the previous year or 2 MS relapse in past 2 years or evidence of 1 or more growth in MRI within 6 months
Core Phase: 0 - 5.5 Expanded Disability Status Scale (EDSS)
Core Phase: Must be able to swallow capsule
Extension Phase: Completion of core phase

What rules you out

Core and Extension phase: Diagnosis of progressive form of MS
Core and Extension Phase: Active or chronic disease of the immune system
Core and Extension Phase: Any cardiovascular, liver, neurological, endocrine, or other major body disease or history or presence of malignancy
Core and Extension Phase: History of any type of epileptic seizures, substance abuse, progressive neurological disorder, or history of suicide attempt
Core and Extension Phase: Pregnant or breastfeeding females
Core and Extension Phase: Previous treatment with certain lymphocyte-depleting therapies or other immunosuppressants
Core and Extension Phase: Discontinued treatment with fingolimod or similar modulator, due to the medication not working

The study team makes the final eligibility decision.

Where it's taking place

Turkey
Argentina
Taiwan
Australia
United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Turkey; Argentina; Taiwan; Australia; United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.