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Metformin Treatment in Progressive Multiple Sclerosis

CompletedEARLY_Phase 1

Sponsor: University of California, Los Angeles

Conditions: Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis

Interventions: Metformin 500 Mg Oral Tablet, up to 4 tablets a day, Placebo oral tablet identical to metformin, up to 4 tablets a day

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 30 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion 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

Exclusion Criteria:

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

Locations (1)

Los Angeles, California, United States