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Sphingosine-1-phosphate receptor modulator

Ozanimod for Multiple Sclerosis

Phase 4

Waitlist Available

Led By Bart Rypma, PhD

Research Sponsored by The University of Texas at Dallas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will look at how a medication called ozanimod can improve cognitive function in people with Multiple Sclerosis. Researchers will use brain imaging and behavioral tests to see how ozanimod affects the brain

Who is the study for?

This trial is for individuals with Relapsing-Remitting Multiple Sclerosis (RRMS) who are interested in the potential cognitive benefits of a drug called Ozanimod. Participants should be willing to undergo neuroimaging and behavioral assessments.Check my eligibility

What is being tested?

The study is testing whether Ozanimod can improve thinking and memory in people with RRMS. It involves brain scans and tests to track changes in cognition and brain activity over time while on this medication.See study design

What are the potential side effects?

Ozanimod may cause side effects like infections, slow heart rate when starting treatment, liver problems, high blood pressure, breathing issues, swelling of the eyes, or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Processing Speed/Symbol-Digit Modality Test (SDMT) Performance

Secondary outcome measures

Change in Cerebral Blood Flow (CBF) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI)

Change in Cerebral Metabolic Rate of Oxygen (CMRO2) as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI)

Change in Volumetric Blood-Oxygen-Level-Dependent (BOLD) signal as Measured by Dual Echo Functional Magnetic Resonance Imaging (fMRI)

+2 more

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734

49%

Influenza Like Illness

12%

Headache

11%

Nasopharyngitis

Upper Respiratory Tract Infection

Orthostatic Hypotension

Pyrexia

Alanine Aminotransferase Increased

Urinary Tract Infection

Hypertension

Pharyngitis

Gamma-Glutamyltransferase Increased

100%

80%

60%

40%

20%

Study treatment Arm

Interferon Beta-1a

Ozanimod 0.5 mg

Ozanimod 1 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: OzanimodExperimental Treatment1 Intervention

Participants will receive Ozanimod and work up to .92 mg. They will then take one pill daily for a duration of 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ozanimod

2020

Completed Phase 3

~3510

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas at DallasLead Sponsor

58 Previous Clinical Trials

106,205 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

80 Patients Enrolled for Multiple Sclerosis

Texas Institute for Neurological DisordersUNKNOWN

Bart Rypma, PhDPrincipal InvestigatorThe University of Texas at Dallas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with Ozanimod for individuals?

"According to our evaluation at Power, Ozanimod's safety is rated as 3 due to it being part of a Phase 4 trial, representing an approved therapy."

Answered by AI

Does the clinical trial include individuals who are older than 65 years?

"Individuals interested in participating must be between 18 and 65 years old as per the study's eligibility requirements."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Per information found on clinicaltrials.gov, this specific trial is not actively seeking participants. The initial posting date was recorded as June 1st, 2024 with the most recent update listed on March 26th, 2024. Despite this particular trial no longer accepting candidates, there are currently 413 alternative trials actively pursuing eligible patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS

Dr. Bart Rypma 2024. "Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06334094.