Effects of fingolimod in treatment of multiple sclerosis

Safety and efficacy of fingolimod in Iranian patients with relapsing-remitting multiple sclerosis compared to interferons

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170604034325N1

Enrollment

Registered

2018-11-29

Start date

2014-11-22

Completion date

Unknown

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis. Multiple sclerosis

Interventions

Intervention group: Daily use of 0.5 mg oral "Fingolimod" for 12 months. It is produced in Iran by "Osve" company with brand name of "fingolid". Chemical structure of findolimod is 2-amino-2-[2-(4 oc

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Relapsing remitting multiple sclerosis according to the McDonald criteria No response or complications to first line multiple sclerosis(MS) drugs Needle phobia Age between 18 - 50 Informed consent form

Exclusion criteria

Exclusion criteria: Significant systemic disease, especially heart disease Lymphopenia Other chronic immune system diseases Varicella zoster, HTLV-1 or TB infection Macular edema Malignancy

Design outcomes

Primary

Measure	Time frame
Proportion of relapse-free patients within 12 months of fingolimod therapy. Timepoint: Number of attacks before intervention and 12 months after initiation of intervention. Method of measurement: No specific measurement tool. Evaluation by a neurologist according to clinical and radiologic findings.;T1 and T2 MRI lesions. Timepoint: MRI scan at baseline (before intervention) and 12 months after treatment with fingolimod. Method of measurement: Magnetic resonance imaging device.	—

Measure

Time frame

Proportion of relapse-free patients within 12 months of fingolimod therapy. Timepoint: Number of attacks before intervention and 12 months after initiation of intervention. Method of measurement: No specific measurement tool. Evaluation by a neurologist according to clinical and radiologic findings.;T1 and T2 MRI lesions. Timepoint: MRI scan at baseline (before intervention) and 12 months after treatment with fingolimod. Method of measurement: Magnetic resonance imaging device.

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Secondary

Measure	Time frame
Expanded disability status scale (EDSS). Timepoint: At baseline (before intervention) and 12 months after initiation of fingolimod therapy. Method of measurement: Expanded disability status scale test.;Blood lymphocyte count. Timepoint: At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy. Method of measurement: Blood sampling-measurement using cell count device.;Aspartate aminotransferase. Timepoint: At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy. Method of measurement: Blood sampling. Measurement using biochemistry auto-analyzer device.;Alanine aminotransferase. Timepoint: At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy. Method of measurement: Blood sampling. Measurement using biochemistry auto-analyzer device.	—

Measure

Time frame

Expanded disability status scale (EDSS). Timepoint: At baseline (before intervention) and 12 months after initiation of fingolimod therapy. Method of measurement: Expanded disability status scale test.;Blood lymphocyte count. Timepoint: At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy. Method of measurement: Blood sampling-measurement using cell count device.;Aspartate aminotransferase. Timepoint: At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy. Method of measurement: Blood sampling. Measurement using biochemistry auto-analyzer device.;Alanine aminotransferase. Timepoint: At baseline (before intervention) and at months 1,3,6 and 12 after initiation of fingolimod therapy. Method of measurement: Blood sampling. Measurement using biochemistry auto-analyzer device.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Yavari

Mashhad University of Medical Sciences

mana_baba_110@yahoo.com+98 51 3882 3103

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026