Use of Well Known Drugs for New Destination - MS Improvement (MSNT)

Multiple Sclerosis Clinical Trial

— MSNT  

Official title:

Expanded Access Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Multiple Sclerosis Not Responding With Commonly Used Treatments

Clinical Trial Details — Status: Temporarily not available

Administrative data

• NCT number: NCT02606929
• Other study ID #: HN1-2015
• Status: Temporarily not available
• Phase: Phase 0
• First received: November 12, 2015
• Last updated: November 13, 2015
• Start date: January 2015
• Est. completion date: November 2015

Study information

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

Clinical Trial Summary

The purpose of this expanded access retrospective study is to determine whether tetracyclines, statins and antimycotics are effective in improvement of life and health condition in the treatment of multiple sclerosis due to autoimmune disease (MS) in all his forms, specially in patients that show no response to commonly used treatments

Description:

The purpose of this expanded access retrospective study is to determine whether tetracyclines, statins and antimycotics are effective in improvement of life and health condition in the treatment of multiple sclerosis due to autoimmune disease (MS) in all his forms.

The method of analysis chosen was 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 treatment had a total duration of 45 days with three active principles subministration for 2 times a day, controlled nutrition, physiotherapy and gymnastics.

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 observational 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: Temporarily not available
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: September 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

N/A

Related Conditions & MeSH terms

• 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 - Statin - Antimycotic
every 12 hours, orally form

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,