Metformin Treatment in Progressive Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Metformin
Placebo or sham
- Placebo oral tablet identical to metformin, up to 4 tablets a day
What it measured
Main measures
number of patients with adverse events between baseline and conclusion (month 0 and month 12)
between month 0 and month 12
Safetynumber of patients with laboratory abnormalities between baseline and conclusion (month 0 and month 12)
between month 0 and month 12
Safetynumber of patients with new T2 lesions on MRI from baseline to conclusion (month 0 and month 12)
between month 0 and month 12
MRI lesions
Other measures (2)
a reduction in localized cortical thinning on brain MRI between baseline and conclusion (month 0 and month 12)
between month 0 and month 12
MRI lesionsa reduction in thalamic atrophy on brain MRI between baseline and conclusion (month 0 and month 12)
between month 0 and month 12
MRI lesionsBrain volume loss
Who could take part
Progressive MS · 30 to 65
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to assess the safety of metformin for treatment of progressive multiple sclerosis
Papers
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History
Started
Apr 2022
Main results due
May 2025
Finished
May 2025
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