Status unknownPhase 2MS (type not specified)NCT05298670

What it found

Missed its main goal

The main measure did not show a significant benefit.

“After 6 months, the change in the median (interquartile range) of the results for both the intervention and control group were; IL17 (- 1.39 (4.19) vs - 0.93 (5.48), p = 0.48), IL22 (- 0.14 (0.48) vs - 0.09 (0.6), p = 0.53), and EDSS (0 vs 0, p = 1), respectively.”
Read by software from the paper's abstract

6 months

GroupnValue
IFNβ-1a alone- 0.93 (5.48)

p = 0.48

Read by software from the paper's abstract

What was tested

Treatment tested

What it measured

Main measures

  • Change in IL17 in both arms as measured by ELISA.

    After 6 months

    Immune response

Other measures (5)

  • Percentage of Quality of Life deterioration in both arms measured by MSQOL-54.

    After 6 months

    Quality of life (reported by participants)
  • Change in IL22 in both arms as measured by ELISA.

    After 6 months

    Immune response
  • Malondialdehyde in both arms as measured by Colorimetric tests.

    After 6 months

  • Degree of remyelination visualized by MRI, it depends on clinician's overview.

    After 6 months

    MRI lesionsMyelin repair
  • Degree of disability assessed by Expanded Disability Status Scale.

    After 6 months

    Disability progression

Who could take part

MS (type not specified) · 18 to 50

Inclusion Criteria: * Age between 18 and 50 years at time of signing informed consent form. * Relapsing- remitting multiple sclerosis as per the McDonald 2017 criteria, including an MRI brain satisfying the 2017 radiological criteria. * Full-field visual evoked potential (VEP) P100 latency in at least one eye of ≥118 ms. * Kurtzke EDSS step 0.0 - 6.0. * At the time of screening, being treated with a stable dose for at least 6 months of a category 1 multiple sclerosis DMT or for at least 2 years with a category 2 DMT. Exclusion Criteria: * People taking medication for Diabetes Mellitus at screening. * Female participants who are pregnant, lactating, planning pregnancy, or unwilling to use reliable contraception during the trial. * Significant liver impairment; alanine aminotransferase > 3 times the upper limit of normal. * People suffering from congestive heart failure, chronic lung disease with hypoxia, and severe anemia. * Patients with compromised renal function ((eGFR \<60 mL/min/1.73m2) or coexistent hypoxic conditions should not be given metformin. * Chronic or acute intake of large amounts of alcohol may potentiate the effect of metformin on lactate metabolism. * Patients had been prescribed oral, intravenous, and intramuscular corticosteroids for one month prior to study.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study aims to evaluate the effect of Metformin as add- on therapy for improving the outcome in RRMS patients.

Papers

Loading reviews and guidelines…

Related trials

History

    1. Started

      Feb 2022

    2. Main results due

      Feb 2023

    3. Finished

      Mar 2023

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error