COMPLETED

Metformin Treatment in Progressive Multiple Sclerosis

Conditions

Secondary Progressive Multiple Sclerosis Primary Progressive Multiple Sclerosis Multiple sclerosis Demyelinating disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety of metformin for treatment of progressive multiple sclerosis

Official Title

A Double-blind, Placebo Controlled Trial of Metformin Treatment in Progressive Multiple Sclerosis

Quick Facts

Study Start:2022-04-26

Study Completion:2025-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05349474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient signed informed consent. 2. Age 30-65 3. Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by the 2017 McDonald Criteria 4. Intent to maintain current MS disease modifying treatment through the trial duration	1. Clinical relapse in prior 12 months 2. New T2 lesion or gadolinium enhancing lesion in prior 12 months 3. Glucocorticoid use in prior six months outside the context of premedication for disease modifying treatment 4. Changes in disease modifying therapy in prior three months 5. Plans to change current disease modifying therapy 6. Contraindication to MRI, inability to tolerate MRI 7. Use of metformin for any other indication 8. Renal dysfunction (GFR \< 60) 9. Hepatic dysfunction (AST or ALT \> 1.5 x upper limit of normal) 10. B12 deficiency 11. Prior poor reaction to metformin 12. Congestive heart failure 13. Alcohol abuse 14. Metabolic acidosis 15. Females who are pregnant or who plan to become pregnant during the 12 months of enrollment, or who wish to breastfeed during any part of the 12 months of enrollment 16. Concomitant use of drugs with drug-drug interactions with metformin 17. Previous adverse effect with metformin treatment

Inclusion Criteria

Exclusion Criteria

1. Patient signed informed consent.
2. Age 30-65
3. Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by the 2017 McDonald Criteria
4. Intent to maintain current MS disease modifying treatment through the trial duration

1. Clinical relapse in prior 12 months
2. New T2 lesion or gadolinium enhancing lesion in prior 12 months
3. Glucocorticoid use in prior six months outside the context of premedication for disease modifying treatment
4. Changes in disease modifying therapy in prior three months
5. Plans to change current disease modifying therapy
6. Contraindication to MRI, inability to tolerate MRI
7. Use of metformin for any other indication
8. Renal dysfunction (GFR \< 60)
9. Hepatic dysfunction (AST or ALT \> 1.5 x upper limit of normal)
10. B12 deficiency
11. Prior poor reaction to metformin
12. Congestive heart failure
13. Alcohol abuse
14. Metabolic acidosis
15. Females who are pregnant or who plan to become pregnant during the 12 months of enrollment, or who wish to breastfeed during any part of the 12 months of enrollment
16. Concomitant use of drugs with drug-drug interactions with metformin
17. Previous adverse effect with metformin treatment

Contacts and Locations

Principal Investigator

Kevin R Patel, MD

PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Kevin R Patel, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-26

Study Completion Date2025-05-30

Study Record Updates

Study Start Date2022-04-26

Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

Multiple sclerosis
Demyelinating disease

Additional Relevant MeSH Terms

Secondary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis