Use on Human Beings of Mix of Known Drugs for New Destination - MS Treatment — NMSNT  

Multiple Sclerosis Clinical Trial

Official title: Use on Human Being of a Mix Between Very Well Known Drugs, Tested Upon Registered Trial n° NCT02606929, to Consider Effectiveness of Improvement After 45 Days

Status Completed

Clinical Trial Summary

The purpose of this interventional study was to evaluate the use on human being of a mix between very well known drugs, tested upon registered trial n° NCT02606929, to consider effectiveness of improvement after 45 days in MS conditions on a larger group of patients based on different study cohorts.

Clinical Trial Description

The purpose of this interventional study was to evaluate the use on human being of a mix between very well known drugs, tested upon registered trial n° NCT02606929, to consider effectiveness of improvement after 45 days in MS conditions on a larger group of patients based on different study cohorts.

The method of analysis chosen was for all cohorts (3) the analysis of movement through the analysis of the mobility with the Barthel Index (disability evaluation) before and after treatment, the analysis of muscle imbalance Kendall before and after treatment and the final EDSS score. The cohorts had defined as group 1: cohort with new compound drug, group 2: cohort with new compound drug and fingolimod, group 3: cohort with new compound drug and copaxone. The treatment had a total duration of 45 days with three active principles subministration for 2 times a day in all groups, fingolimod in group 2 for one capsule daily, copaxone in group 3 for one injection daily; controlled nutrition, physiotherapy and gymnastics in all groups.

All the above mentioned groups showed significant improvement, also if the group 1 has better enhancement than other groups.

Considering the above, therefore, seems promising, also because of the low toxicity of the active, non immunosuppressant action and indeed exciting and synergistic action between them in the interests of recovery of homeostasis of the organism, the conduct of a suitable interventional trial aimed at demonstrating the ability anti inflammatory and potentially reconstruction of damaged tissues, specially in patients that show no response to commonly used treatments ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases
• Disseminated or Multiple Sclerosis Nos
• Multiple Sclerosis
• Multiple Sclerosis, Acute Relapsing
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

• NCT number: NCT02632591
• Study type: Interventional
• Source: Università Popolare Homo & Natura
• Status: Completed
• Phase: Phase 1
• Start date: August 2015
• Completion date: December 2015