Secondary Progressive Multiple Sclerosis Clinical Trial
Official title:
A Double-blind, Placebo Controlled Trial of Metformin Treatment in Progressive Multiple Sclerosis
The purpose of this study is to assess the safety of metformin for treatment of progressive multiple sclerosis
Status | Recruiting |
Enrollment | 44 |
Est. completion date | May 26, 2026 |
Est. primary completion date | May 26, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | improvement in SDMT-oral score between baseline and conclusion (month 0 and month 12) | improvement in SDMT-oral score between comparing the two treatment groups | between month 0 and month 12 | |
Other | improvement in CVLT-II score between baseline and conclusion (month 0 and month 12) | improvement in CVLT-II score between comparing the two treatment groups | between month 0 and month 12 | |
Other | improvement in PACC score between baseline and conclusion (month 0 and month 12) | improvement in PACC score between comparing the two treatment groups | between month 0 and month 12 | |
Other | improvement in PASAT score between baseline and conclusion (month 0 and month 12) | improvement in PASAT score between comparing the two treatment groups | between month 0 and month 12 | |
Other | decrease in plasma neurofilament light chain levels between baseline and conclusion (month 0 and month 12) | decrease in plasma neurofilament light chain levels comparing the two treatment groups | between month 0 and month 12 | |
Other | decrease in number of phase rimmed lesions between baseline and conclusion (month 0 and month 12) | decrease in number of phase rimmed lesions comparing the two treatment groups | between month 0 and month 12 | |
Primary | number of patients with adverse events between baseline and conclusion (month 0 and month 12) | number of patients with adverse events comparing the two treatment groups | between month 0 and month 12 | |
Primary | number of patients with laboratory abnormalities between baseline and conclusion (month 0 and month 12) | number of patients with laboratory abnormalities comparing the two treatment groups | between month 0 and month 12 | |
Primary | number of patients with new T2 lesions on MRI from baseline to conclusion (month 0 and month 12) | number of patients with new T2 lesions comparing the two treatment groups | between month 0 and month 12 | |
Secondary | a reduction in localized cortical thinning on brain MRI between baseline and conclusion (month 0 and month 12) | a reduction in localized cortical thinning on brain MRI comparing the two treatment groups | between month 0 and month 12 | |
Secondary | a reduction in thalamic atrophy on brain MRI between baseline and conclusion (month 0 and month 12) | a reduction in thalamic atrophy on brain MRI comparing the two treatment groups | between month 0 and month 12 |
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