Metformin Treatment in Progressive Multiple Sclerosis

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Apr 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called metformin for people with progressive forms of multiple sclerosis (MS), specifically Secondary Progressive and Primary Progressive MS. The goal is to see if metformin can be a helpful treatment option for these conditions. The trial is currently recruiting participants aged 30 to 65 who have been diagnosed with MS and are willing to continue their current MS treatments throughout the study.

To participate, individuals must be in good health aside from their MS and must not have had any recent disease flare-ups or changes in their MS treatment. Participants will be monitored closely during the trial to ensure their safety and to assess how well metformin works for them. It's important to note that certain health conditions and medications may exclude someone from participating, so potential volunteers should discuss their eligibility with their healthcare provider. Overall, this trial offers a chance to explore new treatment options for those living with progressive MS.

Gender

ALL

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