Metformin add-on clinical study in multiple sclerosis to evaluate brain remyelination and neurodegeneration: a phase IIb triple-blind placebo-controlled randomized clinical trial (MACSiMiSE-BRAIN)

Conditions

Progressive Multiple Sclerosis

Brief summary

Change in walking speed, measured by T25FW, between baseline and 96 weeks of treatment.

Detailed description

Change in Expanded Disability Status Scale (EDSS) between baseline and after 96 weeks of treatment., Change in cognitive function as measured by Symbol Digit Modalities Test (SDMT) between baseline and 96 weeks of treatment., Change in hand function as measured by Nine-Hole Peg Test (9HPT) between baseline and 96 weeks of treatment., Change in the Compisite endpoint as measured by Overall Disability Response Score (ODRS) between baseline and 96 weeks of treatment., Change in 2 minute walk test between baseline and 96 weeks of treatment., Change in brain volume (whole brain volume and gray matter volume) as measured by MRI from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks., Change in brain MRI-DTI metrics (fractional anisotropy (FA), mean diffusivity (MD) and radial diffusivity (RD)) from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks, Change in quality of life as measured by EQ-5D-5L between baseline and 96 weeks of treatment., Change in quality of life as measured by Multiple Sclerosis Impact Scale-29 between baseline and 96 weeks of treatment., Change in number of SWI lesions from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks., Change in Modified Caregiver strain index (MCSI) from baseline to 96 weeks., Average total costs between baseline and 96 weeks of treatment and incremental cost-effectiveness ratio

Anna‐Victoria De Keersmaecker, Eline Van Doninck, Veronica Popescu, Lander Willem, Melissa Cambron et al. (14 authors)

Frontiers in Immunology2024-02-2123 citations

10.3389/fimmu.2024.1362629

Interventions

DRUGGilenya 0.5 mg hard capsules

DRUGTYSABRI 300 mg concentrate for solution for infusion

DRUGThe placebo will be manufactured based on the Metformin Hydrochloride 850 mg (Metformin STADA® 850 mg) specifications to match the characteristics (appearance

DRUGsize) of the IMP

DRUGwithout containing the active ingredient (see IMPD).

DRUGAUBAGIO 14 mg film-coated tablets

DRUGZeposia 0.92 mg hard capsules

DRUGThe placebo will be manufactured based on the metformin hydrochloride 850 mg (metformin ALIUD® 850 mg) specifications to match the characteristics (appearance

DRUGsize) of the imp

DRUGwithout containing the active ingredient (see impd).

DRUGBetaferon 250 microgram/ml

DRUGpowder and solvent for solution for injection

DRUGMayzent 2 mg film-coated tablets

DRUGTecfidera 240 mg gastro-resistant hard capsules

DRUGCopaxone 20 mg/ml oplossing voor injectie in een voorgevulde spuit.

DRUGAVONEX 30 micrograms/0.5 ml solution for injection.

DRUGMetformin STADA® 850 mg Filmtabletten

DRUGKesimpta 20 mg solution for injection in pre-filled syringe

DRUGOcrevus 300 mg concentrate for solution for infusion

DRUGPlegridy 125 micrograms solution for injection in pre-filled syringe

DRUGGlatiramyl 40 mg/ml

DRUGoplossing voor injectie in een voorgevulde spuit

DRUGRebif 22 micrograms solution for injection in pre-filled syringe

DRUGGlatiramyl 20 mg/ml oplossing voor injectie in een voorgevulde spuit

DRUGCopaxone 40 mg/ml oplossing voor injectie in een voorgevulde spuit.

DRUGMayzent 1 mg film-coated tablets

DRUGPonvory 20 mg film-coated tablets

DRUGMetformin AL 850 mg Filmtabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in walking speed, measured by T25FW, between baseline and 96 weeks of treatment.	—

Secondary

Measure	Time frame
Change in Expanded Disability Status Scale (EDSS) between baseline and after 96 weeks of treatment., Change in cognitive function as measured by Symbol Digit Modalities Test (SDMT) between baseline and 96 weeks of treatment., Change in hand function as measured by Nine-Hole Peg Test (9HPT) between baseline and 96 weeks of treatment., Change in the Compisite endpoint as measured by Overall Disability Response Score (ODRS) between baseline and 96 weeks of treatment., Change in 2 minute walk test between baseline and 96 weeks of treatment., Change in brain volume (whole brain volume and gray matter volume) as measured by MRI from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks., Change in brain MRI-DTI metrics (fractional anisotropy (FA), mean diffusivity (MD) and radial diffusivity (RD)) from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks, Change in quality of life as measured by EQ-5D-5L between baseline and 96 weeks of treatment., Change	—

Measure

Time frame

Change in Expanded Disability Status Scale (EDSS) between baseline and after 96 weeks of treatment., Change in cognitive function as measured by Symbol Digit Modalities Test (SDMT) between baseline and 96 weeks of treatment., Change in hand function as measured by Nine-Hole Peg Test (9HPT) between baseline and 96 weeks of treatment., Change in the Compisite endpoint as measured by Overall Disability Response Score (ODRS) between baseline and 96 weeks of treatment., Change in 2 minute walk test between baseline and 96 weeks of treatment., Change in brain volume (whole brain volume and gray matter volume) as measured by MRI from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks., Change in brain MRI-DTI metrics (fractional anisotropy (FA), mean diffusivity (MD) and radial diffusivity (RD)) from baseline to 48 weeks, from baseline to 96 weeks and from 48 to 96 weeks, Change in quality of life as measured by EQ-5D-5L between baseline and 96 weeks of treatment., Change

—

Countries

Belgium

Outcome results

None listed