Status:
COMPLETED
Metformin Treatment in Progressive Multiple Sclerosis
Lead Sponsor:
University of California, Los Angeles
Conditions:
Secondary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis
Eligibility:
All Genders
30-65 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to assess the safety of metformin for treatment of progressive multiple sclerosis
Detailed Description
This will be a single site 1:1 randomized, placebo controlled trial of metformin treatment vs matching placebo in 44 men and women with primary progressive multiple sclerosis and secondary multiple sc...
Eligibility Criteria
Inclusion
- Patient signed informed consent.
- Age 30-65
- Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by the 2017 McDonald Criteria
- Intent to maintain current MS disease modifying treatment through the trial duration
Exclusion
- Clinical relapse in prior 12 months
- New T2 lesion or gadolinium enhancing lesion in prior 12 months
- Glucocorticoid use in prior six months outside the context of premedication for disease modifying treatment
- Changes in disease modifying therapy in prior three months
- Plans to change current disease modifying therapy
- Contraindication to MRI, inability to tolerate MRI
- Use of metformin for any other indication
- Renal dysfunction (GFR \< 60)
- Hepatic dysfunction (AST or ALT \> 1.5 x upper limit of normal)
- B12 deficiency
- Prior poor reaction to metformin
- Congestive heart failure
- Alcohol abuse
- Metabolic acidosis
- 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
- Concomitant use of drugs with drug-drug interactions with metformin
- Previous adverse effect with metformin treatment
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05349474
Start Date
April 26 2022
End Date
May 30 2025
Last Update
July 22 2025
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095