Effects of Rapamycin on multiple Sclerosis treatment

Phase 1

• Conditions: relapsing remitting multiple sclerosis.; Demyelinating diseases of the central nervous system; G35-G37

• Registration Number: IRCT2012092510936N1
• Lead Sponsor: Vice-chancellor of Research and Technology, Isfahan University of Medical Sciences, Isfahan, Iran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Relapsing- Remitting MS; MRI records that proved the existence of demyelination; 0-6 expanded disability status scale (EDSS); lack of response to ß interferon or glatiramer acetate; stopping ß interferon or glatiramer acetate one month before the experimentation .
Exclusion criteria: primary progressive MS; history of immunosuppressive therapy; side effects of the drug; steroid therapy in the last one month; any sign of infection and cancer; cardiovascular and hematological disorders; high serum cholesterol and using medication for it; history of hepatic cirrhosis or other liver diseases that require treatment; history of C and B hepatitis; active CMV infection; renal diseases which require treatment; active lung diseases, diabetes, hyperthyroidism, infection with HIV, tuberculosis; history of alcohol misuse during last 6 months; phobia from MRI (claustrophobia) and pregnant and lactating women.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in plaque area and number, variation in the expesion of FOXP3 gene. Timepoint: Before and 6 months after the therapy with rapamyin. Method of measurement: MRI, real-time PCR.

Secondary Outcome Measures

Name	Time	Method
Th1, 2 and 17 Cytokine variation. Timepoint: Before and 6 months after therapy with rapamycin. Method of measurement: ELISA.