Trial · NCT06463743
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
NCT06463743, Phase 2, Recruiting, State University of New York at Buffalo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS). Trials, record NCT06463743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06463743
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
- NCT number
- NCT06463743
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- State University of New York at Buffalo
- Conditions
- Multiple Sclerosis
- Interventions
- metformin, Placebo
- First posted
- 2024-06-18
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | 1 year | The adverse events (AE) will be collected using standardized Adverse Events Form. The severity of the AE will be determined using 5-level grading system where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Additional information regarding the relation to the study medication (related/non related), treatment required (none/drug/non-drug) and the outcome of the AE will be recorded |
| Primary | Percent change in N-Acetyl Aspartate (NAA) in the cortex over 9 months | 9 months | The MRI scans will be acquired at baseline and 9-month follow-up using magnetic resonance spectroscopy (MRS). |
| Secondary | Disability progression as measured with Expanded Disability Status Scale (EDSS) | 1 year | Disability quantification using Expanded Disability Status Scale (EDSS) (evaluation performed at baseline, 3, 6 and 9 and 12 months). Disability progression will be determined as an increase of 1.0 points in EDSS if the baseline EDSS is \<5.5 and increase of 0.5 points in EDSS over the follow-up period if baseline EDSS is ≥5.5 points. |
| Secondary | Symbol Digit Modality Test (SDMT) | 1 year | A neuropsychological assessment will be included using the Brief International Cognitive Assessment in MS (BICAMS) battery at baseline, and 9 months. Within the BICAMS battery, the cognitive performance will be evaluated using the Symbol Digit Modalities Test (SDMT)-measuring the correct number match within 90 sec ( higher is better- over 60 normal) . Group difference of 4-points in the SDMT test will be considered as significantly meaningful cognitive difference between the metformin-treated and placebo group. |
| Secondary | Brief Visuospatial Memory Test ( BVMT) | 1 year | correct number of figures out of 6 - immediate and delayed after 20 min |
| Secondary | California Verbal Learning Test (CVLT) | 1 year | Number of words remembered immediate and delayed out of a list of 16 words- (max is 16) |
| Secondary | Conventional MRI outcomes | 9 months | Conventional MRI metrics: lesion burden: number and volume of lesions |
| Secondary | Timed 25-foot walk test (T25FWT) | 1 year | Eval of gait, Change of 20% in the T25FWT (seconds) represents a meaningful change |
| Secondary | 9-hole peg test (9HPT) | 1 year | 9HPT measured in seconds performed at baseline, 3, 6 and 9 and 12 months. Change of 20% in the 9HPT (seconds) represents a meaningful change |
| Secondary | Myelin water fraction (MWF) | 9 months | Non-conventional MRI metrics : myelin water fraction (MWF) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR001412 | University of Buffalo Clinical and Translational Science Institute | MURPHY, TIMOTHY F | STATE UNIVERSITY OF NEW YORK AT BUFFALO | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2015 to 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06463743
GET https://conductscience.org/api/trials/v1/NCT06463743/registered