CompletedEarly phase 1Progressive MSNCT05349474

What it found

Result in a paper, not read yet

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

    Safety
  • number of patients with laboratory abnormalities between baseline and conclusion (month 0 and month 12)

    between month 0 and month 12

    Safety
  • number 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 lesions
  • a 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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Related trials

History

    1. Started

      Apr 2022

    2. Main results due

      May 2025

    3. Finished

      May 2025

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