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Metformin Treatment in Progressive Multiple Sclerosis

Study Purpose

The purpose of this study is to assess the safety of metformin for treatment of progressive multiple sclerosis

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	30 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05349474
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, Los Angeles
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kevin R Patel, MD
Principal Investigator Affiliation	University of California, Los Angeles
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis

Additional Details

This will be a single site 1:1 randomized, placebo controlled trial of metformin treatment vs.#46; matching placebo in 44 men and women with primary progressive multiple sclerosis and secondary multiple sclerosis, without diabetes, not treated with metformin aged 30-65. The trial will last 12 months and have 3 study visits, baseline, 6 months, and 12 months. The trial will be preceded by a screening period. Over the initial 30 day titration period subjects will be titrated from 500 mg a day to 2,000 mg of metformin in increments of 500 mg every 10 days. Patients will remain on their tolerated dose and included in analysis on an intent to treat basis. Brain MRI, cognitive testing and clinical measures will be collected at baseline, month 6 and month 12. OCT will be collected at baseline and month 12. The primary outcomes are the following safety outcomes: 1) number of patients with adverse events 2) number of patients with laboratory abnormalities 3) number of patients with new T2 lesions on MRI. The secondary outcomes include reduction in localized cortical thinning on brain MRI; reduction in thalamic atrophy on brain MRI. Further exploratory outcomes include 1) improvement in SDMT-oral score, 2) improvement in CVLT-II score, 3) improvement in PACC score 4) improvement in PASAT score. Exploratory outcomes include 1) Decrease in plasma neurofilament light chain levels, 2) Reginal nerve fiber layer preservation on OCT, 3) Ganglion cell inner plexiform layer preservation, and 4) Percentage of phase rim lesions.

Arms & Interventions

Arms

Experimental: Metformin Treatment

Metformin 500 mg tablets up to 2,000 mg (4 tablets) a day divided into two doses. Patients will start on 500 mg Qday and a titration to maximum dose will be attempted during the first 30 day period of the study.

Placebo Comparator: Placebo Treatment

Placebo tablets identical to metformin 500 mg tablets divided into two doses. Patients will be started on 1 tablet a day and a titration to maximum dose (4 tablets) will be attempted during the first 30 day period of the study.

Interventions

Drug: - Metformin 500 Mg Oral Tablet, up to 4 tablets a day

Metformin 500 mg oral tablets to be titrated to 2000 mg/day divided over two doses or maximum tolerated dose

Drug: - Placebo oral tablet identical to metformin, up to 4 tablets a day

Placebo tablets identical to metformin tablets. To be titrated to four tablets divded over two doses or maximum tolerated dose

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California, Los Angeles

Los Angeles, California, 90095

Site Contact

Michael Montag

[email protected]

310-205-2176

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