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
Name Time Method 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
Name Time Method 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.