Metformin for Older Adults with Multiple Sclerosis
This study is looking into how safe and effective metformin is for people aged 55 to 75 with multiple sclerosis (MS). Metformin is a drug that may be used alone or in addition to your current MS treatment. Researchers want to see if metformin can protect your nervous system and brain tissue from damage related to MS and aging. They will compare metformin to a placebo (an inactive substance) over a 9-month period. The study aims to enroll 30 participants who have a confirmed MS diagnosis, have not had recent relapses or MRI activity, and have an EDSS score (a measure of disability) less than 7.0. The study's current status is unclear.
- Study design
- This interventional study plans to enroll 30 participants to compare metformin to a placebo. The phase of the study is not specified.
- What's involved
- The study measures adverse events for 1 year and changes in brain markers over 9 months. This suggests regular visits and MRI scans over this period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for treatment-related adverse events for 1 year after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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
- Percent change in N-Acetyl Aspartate (NAA) in the cortex over 9 months9 months
The MRI scans will be acquired at baseline and 9-month follow-up using magnetic resonance spectroscopy (MRS).