Metformin Treatment in Progressive Multiple Sclerosis

NCT05349474 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 22-000020
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis

Keywords

Multiple sclerosis; Demyelinating disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (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

• a reduction in thalamic atrophy on brain MRI between baseline and conclusion (month 0 and month 12)

  between month 0 and month 12

Other Outcomes (6)

• improvement in SDMT-oral score between baseline and conclusion (month 0 and month 12)

  between month 0 and month 12

• improvement in CVLT-II score between baseline and conclusion (month 0 and month 12)

  between month 0 and month 12

• improvement in PACC score between baseline and conclusion (month 0 and month 12)

  between month 0 and month 12

Study Arms (2)

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.

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.

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

Interventions

Metformin 500 Mg Oral Tablet, up to 4 tablets a day DRUG

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

Metformin Treatment

Placebo oral tablet identical to metformin, up to 4 tablets a day DRUG

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

Placebo Treatment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis; Demyelinating Diseases

Interventions

Metformin; Tablets

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Kevin R Patel, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Neurology

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: April 26, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)