Trial · NCT06463743
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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) |
| Other | Exploratory/tertiary MRI metrics | 9 months | Exploratory/tertiary MRI metrics assessment of cortical lesion burden using synthetic DIR sequence and perfusion-based imaging using arterial spin labeling (ASL). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT06463743/registered