This is a single-arm, open-label, before-and-after interventional clinical trial conducted at Ayatollah Kashani Educational and Medical Center in Isfahan, Iran. The study aims to evaluate the efficacy and safety of ozanimod in patients with relapsing-remitting multiple sclerosis (RRMS). Eligible participants will receive ozanimod hydrochloride at a daily dose of 0.5 milligrams for 24 months. Clinical outcomes will be assessed using the Expanded Disability Status Scale (EDSS), the Nine-Hole Peg Test (9HPT), and the Timed 25-Foot Walk Test (T25FW). Disease relapses, magnetic resonance imaging (MRI) lesions, and adverse events will also be recorded. The study will be conducted without blinding.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Written informed consent
Age between 18 and 50 years
Definite diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2024 McDonald criteria
Expanded Disability Status Scale (EDSS) score less than 3.5
Exclusion Criteria:
Pregnancy or breastfeeding
Progressive forms of multiple sclerosis
Cardiac conduction block
Untreated severe obstructive sleep apnea
Liver diseases
Uncontrolled hypertension
Intervention groups
Eligible patients with relapsing-remitting multiple sclerosis (RRMS) receiving oral ozanimod hydrochloride 0.5 mg (equivalent to 0.46 mg ozanimod) once daily for 24 months.
Main outcome variables
Change in Expanded Disability Status Scale (EDSS) score following ozanimod treatment in patients with relapsing-remitting multiple sclerosis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171220037977N2
Registration date:2026-06-27, 1405/04/06
Registration timing:registered_while_recruiting
Last update:2026-06-27, 1405/04/06
Update count:0
Registration date
2026-06-27, 1405/04/06
Registrant information
Name
Vahid Shaygannejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3667 6292
Email address
shaygannejad@med.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-07-24, 1404/05/02
Expected recruitment end date
2027-08-21, 1406/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of ozanimod in patients with multiple sclerosis: a clinical trial
Public title
Evaluation of efficacy and safety of ozanimod
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
written informed consent
Age between 18 and 50 years
Definite diagnosis of multiple sclerosis according to the 2024 McDonald criteria
Relapsing-remitting multiple sclerosis (RRMS)
EDSS score < 3.5
At least one documented relapse during the previous 24 months
Patients previously treated with the first-line disease-modifying therapies or patients who experienced severe adverse affects from second-line therapies such as infection or treatment-resistant hypogammaglobulinemia
Exclusion criteria:
Pregnancy or breastfeeding
Progressive forms of multiple sclerosis
Cardiac conduction block
Untreated severe obstructive sleep apnea
Liver disease
Uncontrolled hypertension
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2025-07-21, 1404/04/30
Ethics committee reference number
IR.MUI.MED.REC.1404.161
Health conditions studied
1
Description of health condition studied
Relapsing-remitting Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Change in Expanded Disability Status (EDSS) score in patients with relapsing-remitting multiple sclerosis following ozanimod treatment.
Timepoint
24 months after treatment initiation
Method of measurement
Disability status assessed using the standardized Expanded Disability Status Scale (EDSS) by a trained neurologist.
Secondary outcomes
1
Description
change in number of disease relapse in patients with relapsing-remitting multiple sclerosis during 24 months of Ozanimod treatment.
Timepoint
24 months after treatment
Method of measurement
The number of disease relapse recorded and assessed based on neurologist evaluation and review of patients' medical records.
Intervention groups
1
Description
Intervention group: Eligible patients with relapsing-remitting multiple sclerosis (RRMS) receiving ozanimod treatment. Participants will receive oral ozanimod hydrochloride 0.5 mg manufactured by Zist Darou (equivalent to 0.46 mg ozanimod) once daily for 24 months.