Metformin Treatment in Progressive Multiple Sclerosis

• Status: Not yet recruiting
• Trial end date: 2025-05-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Metformin

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