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

Sponsor
University Hospital, Antwerp
Study ID
NCT05893225
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride 850 mg Oral Tablet — DRUG
    Metformin Hydrochloride oral tablets 850 mg t.i.d. or b.i.d.
  • Placebo — DRUG
    Placebo matching Metformin Hydrochloride oral tablets t.i.d. or b.i.d.

Study Details

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.

Key Dates

Start date
Nov 23, 2023
Status verified
Apr 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment group
    The treatment group will receive Metformin Hydrochloride oral tablets 850mg tid or bid, during a maximum of 96 weeks.
  • Placebo Comparator: Control group
    The control group will receive a matching placebo, during a maximum of 96 weeks.

Primary Outcome Measure

Change in walking speed [ Time Frame: From baseline to 96 weeks ]

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