Secondary Progressive Multiple SclerosisEarly Phase 1NCT05349474
Metformin Treatment in Progressive Multiple Sclerosis
A Early Phase 1 study testing Metformin 500 Mg Oral Tablet, up to 4 tablets a day in people with Secondary Progressive Multiple Sclerosis and Primary Progressive Multiple Sclerosis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety of metformin for treatment of progressive multiple sclerosis Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis
- What is being tested?
- Metformin 500 Mg Oral Tablet, up to 4 tablets a day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 30 May 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient signed informed consent.
- Age 30-65
- Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by the 2017 McDonald Criteria
- Intent to maintain current MS disease modifying treatment through the trial duration
Who cannot join
- Clinical relapse in prior 12 months
- New T2 lesion or gadolinium enhancing lesion in prior 12 months
- Glucocorticoid use in prior six months outside the context of premedication for disease modifying treatment
- Changes in disease modifying therapy in prior three months
- Plans to change current disease modifying therapy
- Contraindication to MRI, inability to tolerate MRI
Show all 17Show fewer
- Use of metformin for any other indication
- Renal dysfunction (GFR < 60)
- Hepatic dysfunction (AST or ALT > 1.5 x upper limit of normal)
- B12 deficiency
- Prior poor reaction to metformin
- Congestive heart failure
- Alcohol abuse
- Metabolic acidosis
- 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
- Concomitant use of drugs with drug-drug interactions with metformin
- Previous adverse effect with metformin treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
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
Read the detailed description
This will be a single site 1:1 randomized, placebo controlled trial of metformin treatment vs 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.
- Being tested
- Metformin 500 Mg Oral Tablet, up to 4 tablets a day, Placebo oral tablet identical to metformin, up to 4 tablets a day
- Keywords
- Multiple sclerosis, Demyelinating disease
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 500 Mg Oral Tablet, up to 4 tablets a dayDrug
Metformin 500 mg oral tablets to be titrated to 2000 mg/day divided over two doses or maximum tolerated dose
Placebo oral tablet identical to metformin, up to 4 tablets a dayDrug
Placebo tablets identical to metformin tablets. To be titrated to four tablets divded over two doses or maximum tolerated dose
| Study group | Role | What they receive |
|---|---|---|
| Metformin Treatment | Experimental | 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. Receives: Drug: Metformin 500 Mg Oral Tablet, up to 4 tablets a day |
| Placebo Treatment | Placebo comparator | 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. Receives: Drug: Placebo oral tablet identical to metformin, up to 4 tablets a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between month 0 and month 12
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
Measured: between month 0 and month 12
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
Measured: between month 0 and month 12
Secondary outcomes (2)
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
Measured: between month 0 and month 12
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
Measured: between month 0 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start26 Apr 2022
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Patel, University of California, Los Angeles
- Investigators
- Kevin R Patel, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349474
- Sponsor's protocol ID
- 22-000020
- Status last verified
- Jul 2025
- First submitted
- 21 Apr 2022
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled Trial of Metformin Treatment in Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05349474
- Acronym / sponsor ID
- 22-000020
- Keywords
- Multiple sclerosis, Demyelinating disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety of metformin for treatment of progressive multiple sclerosis
Detailed description
This will be a single site 1:1 randomized, placebo controlled trial of metformin treatment vs 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin Treatment | Experimental | Drug: Metformin 500 Mg Oral Tablet, up to 4 tablets a dayMetformin 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 Treatment | Placebo comparator | Drug: Placebo oral tablet identical to metformin, up to 4 tablets a dayPlacebo 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient signed informed consent.
- Age 30-65
- Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by the 2017 McDonald Criteria
- Intent to maintain current MS disease modifying treatment through the trial duration
Key exclusion criteria (17 listed)
- Clinical relapse in prior 12 months
- New T2 lesion or gadolinium enhancing lesion in prior 12 months
- Glucocorticoid use in prior six months outside the context of premedication for disease modifying treatment
- Changes in disease modifying therapy in prior three months
- Plans to change current disease modifying therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin 500 Mg Oral Tablet, up to 4 tablets a dayMetformin 500 mg oral tablets to be titrated to 2000 mg/day divided over two doses or maximum tolerated dose | Drug | Metformin Treatment |
| Placebo oral tablet identical to metformin, up to 4 tablets a dayPlacebo tablets identical to metformin tablets. To be titrated to four tablets divded over two doses or maximum tolerated dose | Drug | Placebo Treatment |
Primary outcome
number of patients with adverse events between baseline and conclusion (month 0 and month 12)
Time frame: between month 0 and month 12
number of patients with adverse events comparing the two treatment groups
number of patients with laboratory abnormalities between baseline and conclusion (month 0 and month 12)
Time frame: between month 0 and month 12
number of patients with laboratory abnormalities comparing the two treatment groups
number of patients with new T2 lesions on MRI from baseline to conclusion (month 0 and month 12)
Time frame: between month 0 and month 12
number of patients with new T2 lesions comparing the two treatment groups
2 secondary outcomes
a reduction in localized cortical thinning on brain MRI between baseline and conclusion (month 0 and month 12)
Time frame: between month 0 and month 12
a reduction in thalamic atrophy on brain MRI between baseline and conclusion (month 0 and month 12)
Time frame: between month 0 and month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin R Patel, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin 500 Mg Oral Tablet, up to 4 tablets a day in people with Secondary Progressive Multiple Sclerosis and Primary Progressive Multiple Sclerosis, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with adverse events between baseline and conclusion (month 0 and month 12) (time frame: between month 0 and month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.