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Metformin Add-on Clinical Study in Multiple Sclerosis to Evaluate Brain Remyelination And Neurodegeneration

NCT05893225 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-24

No results posted yet for this study

Summary

This clinical trial aims to demonstrate that metformin can prevent clinical disability in patients with progressive MS by stopping or slowing down neurodegeneration by enhancing endogenous remyelination. Patients will continue their DMT treatment: metformin or placebo will be used as add-on study treatment.

Conditions

Interventions

DRUG

Metformin Hydrochloride 850 mg Oral Tablet

Metformin Hydrochloride oral tablets 850 mg t.i.d. or b.i.d.

DRUG

Placebo

Placebo matching Metformin Hydrochloride oral tablets t.i.d. or b.i.d.

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • Hasselt University

    collaborator OTHER

  • AZ Sint-Jan AV

    collaborator OTHER

  • Noorderhart Pelt

    collaborator OTHER

  • National MS Center Melsbroek

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Barbara Willekens, MD, PhD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-23
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05893225 on ClinicalTrials.gov