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Biguanide
Metformin for Progressive Multiple Sclerosis
Phase < 1
Recruiting
Led By Kevin R Patel, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 30-65
Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by the 2017 McDonald Criteria
Must not have
Plans to change current disease modifying therapy
Renal dysfunction (GFR < 60)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between month 0 and month 12
Summary
This trial is testing metformin, a diabetes medication, to see if it can help adults aged 30-65 with progressive multiple sclerosis. The goal is to find out if metformin can reduce inflammation and protect nerve cells, potentially slowing down the disease.
Who is the study for?
This trial is for people aged 30-65 with Progressive Multiple Sclerosis who have been stable on their current MS treatment for at least three months. They must not have had a clinical relapse or new lesions in the past year and should not be using metformin for other conditions, nor have kidney or liver issues, B12 deficiency, heart failure, alcohol abuse, metabolic acidosis, or plans to become pregnant.
What is being tested?
The study is testing the safety of metformin (up to four 500 mg tablets daily) compared to a placebo in treating progressive multiple sclerosis. Participants will continue their usual MS treatments during the trial and either add metformin or a look-alike pill without active medication.
What are the potential side effects?
Potential side effects of metformin include digestive upset like nausea and diarrhea, risk of vitamin B12 deficiency over time, and very rarely a serious condition called lactic acidosis where too much acid builds up in the blood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30 and 65 years old.
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My condition is diagnosed as progressive multiple sclerosis according to the 2017 criteria.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I plan to change my current treatment for my condition.
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My kidney function is reduced.
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I am not pregnant, planning to become pregnant, or breastfeeding during the trial.
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I have had a bad reaction to metformin before.
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My condition worsened in the last year.
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I had a bad reaction to metformin.
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I am not taking any medications that interact with metformin.
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I am currently taking metformin for a condition other than diabetes.
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My liver tests are higher than normal.
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I have been diagnosed with congestive heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between month 0 and month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between month 0 and month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
number of patients with adverse events between baseline and conclusion (month 0 and month 12)
number of patients with laboratory abnormalities between baseline and conclusion (month 0 and month 12)
number of patients with new T2 lesions on MRI from baseline to conclusion (month 0 and month 12)
Secondary study objectives
a reduction in localized cortical thinning on brain MRI between baseline and conclusion (month 0 and month 12)
a reduction in thalamic atrophy on brain MRI between baseline and conclusion (month 0 and month 12)
Other study objectives
decrease in number of phase rimmed lesions between baseline and conclusion (month 0 and month 12)
decrease in plasma neurofilament light chain levels between baseline and conclusion (month 0 and month 12)
improvement in CVLT-II score between baseline and conclusion (month 0 and month 12)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Metformin TreatmentExperimental Treatment1 Intervention
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.
Group II: Placebo TreatmentPlacebo Group1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) such as dimethyl fumarate, glatiramer acetate, and metformin. Dimethyl fumarate works by activating the Nrf2 pathway, which reduces oxidative stress and inflammation.
Glatiramer acetate mimics myelin basic protein, distracting the immune system from attacking myelin. Metformin, although primarily a diabetes medication, has shown potential in MS by increasing regulatory T cells and reducing inflammation.
These mechanisms are crucial for MS patients as they help to reduce relapse rates, slow disease progression, and manage symptoms by targeting the underlying immune dysfunction and neurodegeneration characteristic of MS.
Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program.Immunologic Effects of Metformin and Pioglitazone Treatment on Metabolic Syndrome and Multiple Sclerosis.Adoptive transfer of cytokine-induced immunomodulatory adult microglia attenuates experimental autoimmune encephalomyelitis in DBA/1 mice.
Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program.Immunologic Effects of Metformin and Pioglitazone Treatment on Metabolic Syndrome and Multiple Sclerosis.Adoptive transfer of cytokine-induced immunomodulatory adult microglia attenuates experimental autoimmune encephalomyelitis in DBA/1 mice.
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,562 Previous Clinical Trials
10,262,317 Total Patients Enrolled
7 Trials studying Multiple Sclerosis
305 Patients Enrolled for Multiple Sclerosis
Kevin R Patel, MDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 30 and 65 years old.I plan to change my current treatment for my condition.My kidney function is reduced.I am not pregnant, planning to become pregnant, or breastfeeding during the trial.I have had a bad reaction to metformin before.My condition worsened in the last year.I had a bad reaction to metformin.I haven't changed my disease treatment in the last 3 months.I have signed the informed consent form.I am not taking any medications that interact with metformin.I have used glucocorticoids in the last 6 months, not just as premedication.I am currently taking metformin for a condition other than diabetes.My liver tests are higher than normal.My condition is diagnosed as progressive multiple sclerosis according to the 2017 criteria.I have been diagnosed with congestive heart failure.I plan to continue my current MS treatment throughout the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Treatment
- Group 2: Metformin Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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