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

Multiple Sclerosis Clinical Trial

— NMSNT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632591
• Other study ID #: HN3-2015
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2015
• Last updated: December 15, 2015
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Università Popolare Homo & Natura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Multiple Sclerosis

• EDSS score range from 3 to 7,5

Exclusion Criteria:

• Liver diseases: GOT GPT = 40

• Kidney diseases: Creatinine > 1,50

• Use of psychotropic drugs

• Other musculoskeletal diagnoses, unstable cardiovascular, respiratory, metabolic or other conditions that would interfere with this study

• Received a course of steroids (IV or oral) within 60 days of screening

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

Intervention

Drug:
• Tetracycline
every 12 hours orally form
• statin
every 12 hours
• antimycotic
every 12 hours
• Fingolimod
every 24 hours
• copaxone
every 24 hours

Locations

Country	Name	City	State
Italy	Centro Medico Forme di Bellezza	Terni	TR

Sponsors (1)

Lead Sponsor	Collaborator
Università Popolare Homo & Natura

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Disability level at 45 days using expanded disability status scale	use of EDSS (expanded disability status scale)	baseline - 45 days	No
Secondary	Change from baseline in Muscle imbalance level at 45 days using Kendall Test	use of Kendall Test	baseline - 45 days	No
Secondary	Change from baseline in mobility level at 45 days using Barthel Index	use of Barthel Index	baseline - 45 days	No