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Effects of fingolimod in treatment of multiple sclerosis

Phase 2
Conditions
Multiple Sclerosis.
Multiple sclerosis
Registration Number
IRCT20170604034325N1
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
50
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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
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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